Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices(Order of the Ministry of Health, Labour and Welfare No. 1 of 1961)
Last Version: Order of the Ministry of Health, Labour and Welfare No. 82 of 2015
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Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Order of the Ministry of Health, Labour and Welfare No. 1 of February 1, 1961
Based on the provisions of Articles 7 and 10 (including as applied mutatis mutandis pursuant to Articles 38 and 40), Article 14, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23), Article 17, paragraph (1) (including as applied mutatis mutandis pursuant to Article 23), Article 19 (including as applied mutatis mutandis pursuant to Article 23), Article 21 (including as applied mutatis mutandis pursuant to Article 23), Article 29, Article 32, Article 33, paragraph (2), Article 39, paragraph (1), Article 43, paragraph (1), Article 44, paragraphs (1) and (2), Article 49, paragraph (2), Article 50, Article 52, and Article 53 (including as applied mutatis mutandis pursuant to Articles 60, 62 and 64) Articles 58, 59, 61, 63 and 82 of the Pharmaceutical Affairs Act (Act No. 145 of 1960), and Articles 2, 8, 9, 11, 15, and 16, and the row of Tools and Instruments, item (84) of Appended Table 1 of the Order for Enforcement of the Pharmaceutical Affairs Act (Cabinet Order No. 11 of 1961), the Regulation for Enforcement of the Pharmaceutical Affairs Act is hereby enacted as follows.
Chapter I Pharmacy(Articles 1 to 18)
Chapter II Marketing and Manufacturing Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics(Articles 19 to 114)
Chapter III Marketing and Manufacturing Medical Devices and In-Vitro Diagnostics
Section 1 Marketing and Manufacturing Medical Devices and In-Vitro Diagnostics(Articles 114-2 to 114-85)
Section 2 Registered Certification Bodies(Articles 115 to 137)
Chapter IV Marketing and Manufacturing Regenerative Medicine Products(Articles 137-2 to 137-78)
Chapter V Selling Pharmaceuticals, Medical Devices and Regenerative Medicine Products(Articles 138 to 196-13)
Chapter VI Official Verification of Pharmaceuticals(Articles 197 to 203)
Chapter VII Handling of Pharmaceuticals(Articles 204 to 228-9)
Chapter VIII Advertisement of Pharmaceuticals(Article 228-10)
Chapter IX Safety Measures for Pharmaceuticals(Articles 228-11 to 228-27)
Chapter X Special Provisions Concerning Biological Products(Articles 229 to 243)
Chapter XI Supervision(Articles 244 to 249)
Chapter XII Handling of Designated Substances(Articles 249-2 to 249-8)
Chapter XIII Designation of Orphan Drugs, Orphan Medical Devices, and Orphan Regenerative Medicine Products(Articles 250 to 252)
Chapter XIV Miscellaneous Provisions(Articles 253 to 288)
Chapter I Pharmacy
(Application for Establishment)
Article 1(1)Written applications prescribed in Article 4, paragraph (2) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter called the "Act") are to be based on Form No. 1.
(2)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (2), item (vi) of the Act are as follows:
(i)whether an applicant (including an officer in charge of operations if the applicant is a corporation) falls under any of Article 5, item (iii), (a) through (d) and (e) of the Act (excluding the part pertaining to a person who is addicted to narcotics, cannabis, opium, or stimulants);
(ii)normal business days and business hours;
(iii)the telephone number or other contact information for times of consultation and in emergencies;
(iv)whether specified sales (sales or provision of OTC pharmaceuticals or pharmacy-made pharmaceuticals (excluding any poisonous drugs and deleterious drugs; the same applies in paragraph (4), item (ii), (e) and Article 15-6) to persons at the pharmacy or at a pharmacy in a store or at a location other than the store; the same applies hereinafter) have been implemented.
(3)Criteria specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (3), item (iv), (a) of the Act are as follows:
(i)pharmacy-only pharmaceuticals (excluding pharmacy-made pharmaceuticals);
(ii)pharmacy-made pharmaceuticals;
(iii)pharmaceuticals requiring guidance;
(iv)schedule I pharmaceuticals;
(v)designated schedule II pharmaceuticals (meaning schedule II pharmaceuticals designated by the Minister of Health, Labour and Welfare as requiring special care; the same applies hereinafter);
(vi)schedule II pharmaceuticals (excluding designated schedule II pharmaceuticals; the same applies in item (ii) of the following paragraph and Article 15-6, item (iii));
(vii)schedule III pharmaceuticals.
(4)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (3), item (iv), (b) of the Act are as follows:
(i)the means of communication used in specified sales;
(ii)criteria for pharmaceuticals to be sold in specified sales set forth in (a) to (e) below:
(a)schedule I pharmaceuticals;
(b)designated schedule II pharmaceuticals;
(c)schedule II pharmaceuticals;
(d)schedule III pharmaceuticals;
(e)pharmacy-made pharmaceuticals;
(iii)in cases where there is the time for making specified sales or the time exclusively for making specified sales during business hours, the time;
(iv)in cases of labeling a name different from the name of the pharmacy indicated in a written application prescribed in Article 4, paragraph (2) of the Act in an advertisement for specified sales, the name;
(v)if specified sales are advertised on the Internet, a main web page address and summary of a main web page configuration;
(vi)a prefectural governor (if the location is in a city specified by Cabinet Order prescribed in Article 5, paragraph (1) of the Community Health Act (Act No. 101 of 1947) (hereinafter referred to as a "city with established health centers") or a special ward, the mayor of the city or the head of the special ward; the same applies in paragraph (6), Articles 6 and Article 15-6, item (iv)) or outline of the equipment required for the Minister of Health, Labour and Welfare to properly supervise the methods of carrying out specified sales (limited to cases where there is the time exclusively for making specified sales during the business hours of the pharmacy).
(5)Documents specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (3), item (v) of the Act are as follows:
(i)a certificate of registered information in the case of a corporation;
(ii)documents including working hours per week (regular working hours per week) of a pharmacy manager (including a pharmacy proprietor responsible for practical management of the pharmacy pursuant to the provisions of Article 7, paragraph (1) of the Act; the same applies hereinafter except in the following item) and a registration number and a registration date of the register of pharmacists;
(iii)a copy of the employment agreement of a pharmacy manager and other documents proving an employment relationship between the applicant and the pharmacy manager, in cases where the pharmacy manager is designated for practical management of the pharmacy pursuant to the provisions of the proviso of Article 7, paragraph (1) of the Act or the provisions of Article 7, paragraph (2) of the Act;
(iv)documents showing whether the person is a pharmacist or a registered sales clerk, working hours per week, and a registration number and a registration date of the register of pharmacists or those of the registration under Article 36-8, paragraph (2) of the Act (hereinafter referred to as the "sales engagement registration"), in cases of assigning a pharmacist or a registered sales clerk who engages in pharmaceutical practice at the pharmacy besides the pharmacy manager;
(v)a copy of an employment agreement of the pharmacist engaged in pharmaceutical practices or the registered sales clerk and other documents proving an employment relationship of applicant with the pharmacist or registered sales clerk, in cases of assigning a pharmacist or a registered sales clerk who engages in pharmaceutical practice at the pharmacy besides the pharmacy manager;
(vi)documents showing the average number of prescriptions handled per day (meaning the average number of prescriptions handled per day provided in Article 1, paragraph (1), item (ii) of the Ministerial Order to Determine the System for Pharmacies, Store-Based Distribution, and Household Distribution (Order of the Ministry of Health and Welfare No. 3 of 1964); the same applies hereinafter);
(vii)documents showing types of radioactive pharmaceuticals and the outline of equipment required to handle radioactive pharmaceuticals when the pharmacy intends to deal with radioactive pharmaceuticals (meaning radioactive pharmaceuticals provided in Article 1, item (i) of the Rules to Manufacture and Handle Radioactive Pharmaceuticals (Order of the Ministry of Health and Welfare No. 4 of 1961); the same applies hereinafter) (excluding the case where the pharmacy intends to handle radioactive pharmaceuticals below the quantity or concentration specified by the Minister of Health, Labour and Welfare);
(viii)documents showing types of operations undertaken at the pharmacy if selling pharmaceuticals or other businesses are also carried out there;
(ix)a doctor's written diagnosis with regard to mental impairment of the applicant (an officer responsible for the operation if the applicant is a corporation; the same applies in hereinafter in this item), or whether or not the applicant is addicted to narcotics, cannabis, opium, or stimulant.
(6)From among the documents set forth in each item of Article 4, paragraph (3) of the Act, those submitted to a prefectural governor who is in charge of receiving the written applications at the time of application or notification of license, etc. under the Act (hereinafter referred to as "applications and other acts") or submitted to the Minister of Health, Labour and Welfare via the prefectural governor are not required to be attached, if the written application has a supplementary note to that effect.
(7)The applicant may submit a document which shows the officer does not fall under Article 5, item (iii), (e) of the Act (except the part pertaining to adult wards; the same applies hereinafter) and (f) in place of a written diagnosis set forth in paragraph (5), item (ix) in cases where an applicant is a corporation, and a prefectural governor (in cases where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward) acknowledges the services are not adversely affected according to contents of the duties of the officer.
(8)The applicant is to present a registration certificate for completion of re-education prescribed in paragraph (3) of the same Article or attach its copy if a pharmacy manager is ordered by the Minister of Health, Labour and Welfare under Article 8-2, paragraph (1) of the Pharmacists Act (Act No. 146 of 1960) (hereinafter referred to as the "order for reeducation and training")
(Form for License Certificate for Establishing Pharmacies)
Article 2A license certificate for establishing a pharmacy is to be based on Form No. 2.
(Display Form for License Certificate for Establishing Pharmacies)
Article 3A pharmacy proprietor must display a license certificate for establishing a pharmacy at a readily visible place in the pharmacy.
(Written Application for Updated Issuance of License Certificate for Establishing Pharmacies)
Article 4A written application for an updated issuance of a license certificate for establishing a pharmacy prescribed in Article 1-5, paragraph (2) of the Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the "Order") is to be based on Form No. 3.
(Written Application for Reissuance of License Certificate for Establishing Pharmacies)
Article 5A written application for reissuance of a license certificate for establishing a pharmacy prescribed in Article 1-6 paragraph (2) of the Order is to be based on Form No. 4.
(Application for Renewal of License for Establishing Pharmacies)
Article 6An applicant who intends to receive a renewal of a license certificate for establishing a pharmacy pursuant to the provisions of Article 4, paragraph (4) of the Act must submit a written application based on Form No. 5 with the license certificate for establishing a pharmacy to a prefectural governor.
(Matters to Be Included in Registry of License for Establishing Pharmacies)
Article 7Matters to be included in the registry of license under Article 4, paragraph (1) of the Act provided in Article 1-8 of the Order are as follows:
(i)the license number and date;
(ii)the name of a pharmacy proprietor (in the case of a corporation, its name; the same applies hereinafter) and address (in the case of a corporation, the location of its principal office; the same applies hereafter);
(iii)the name and location of the pharmacy;
(iv)normal business days and business hours;
(v)the telephone number or other contact information for times of consultation and in emergencies;
(vi)the name, address, and working hours per week of a pharmacy manager;
(vii)the name, address, and working hours per week of a pharmacist engaged in pharmaceutical practice or a registered sales clerk who works for the pharmacy other than the pharmacy manager, if any;
(viii)the average number of prescriptions handled per day;
(ix)types of radioactive pharmaceuticals at the time of handling them;
(x)types of operations undertaken at the pharmacy if selling pharmaceuticals or other businesses are also carried out there;
(xi)criteria for pharmaceuticals sold or provided at the pharmacy which are set forth in each item of Article 1, paragraph (3);
(xii)matters set forth in each item of Article 1, paragraph (4) when the pharmacy conducts specified sales (excluding the overview of the configuration of the main website; the same applies in Article 16-2, paragraph (1), item (iii)).
(Period Specified by Order of the Ministry of Health, Labour and Welfare Prescribed in Article 4, Paragraph (5), Item (iii), (a) and (b) of the Act)
Article 7-2(1)The period specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (5), item (iii), (a) of the Act is the period set forth in each of the following items in accordance with the criteria for pharmaceuticals set forth in the following items:
(i)new pharmaceuticals provided in Article 14-4, paragraph (1), item (i) of the Act:the investigation period provided in Article 14-4, paragraph (1), item (i) of the Act (the extended period if the period has been extended under paragraph (2) of the same Article);
(ii)pharmaceuticals that are obliged to receive an investigation regarding post-marketing safety for a person who has obtained a marketing approval as a condition for the approval based on the provisions of Article 79, paragraph (1) of the Act (excluding the early post-marketing phase vigilance (hereinafter referred to as "EPPV") provided in Article 10, paragraph (1) of the Ministerial Order on Standards for Post-Marketing Safety Control of Pharmaceuticals, Quasi-Pharmaceutical Products, Cosmetics, Medical Devices, and Regenerative Medicine Products (Order of the Ministry of Health, Labour and Welfare No. 135 of 2004)):the investigation period offered as a condition for marketing approval.
(2)The period specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 4, paragraph (5), item (iii), (b) of the Act is the period until the expiration date of the periods prescribed in each item of the preceding paragraph relating to pharmaceuticals set forth in (a) of the same item whose active components, quantities, usages, efficacies, indications, effects, etc. are found to have equivalence with pharmaceuticals set forth in (b) of the same item.
(Persons Specified by Order of the Ministry of Health, Labour and Welfare Prescribed in Article 5, Item (iii), (f) of the Act)
Article 8Persons specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 5, item (iii), (f) of the Act are those who are unable to adequately carry out the reasoning, decision making, and communication necessary for appropriately engaging in the services of a pharmacy proprietor due to mental impairment.
(Consideration of Treatments)
Article 9If finding that a person who applies for a license for establishing a pharmacy falls under a person provided in the preceding Article, and determining whether to provide a license to the applicant, a prefectural governor (in case of a city with established health centers or a special ward, the mayor of the city or the head of the special ward) must take into account the situation where the level of disability is reduced by medical treatment that the applicant is actually receiving.
(Special Provisions on Uses of Names)
Article 10A place that can have a name of pharmacy in accordance with provisions of the proviso of Article 6 of the Act is a dispensary of a hospital or a clinic.
Article 11Deletion
(Report to Prefectural Governor)
Article 11-2A report to a prefectural governor under Article 8-2, paragraph (1) of the Act is to be delivered by the day specified by the prefectural governor one or more times per year.
(Matters to Be Reported by Establisher of Pharmacy)
Article 11-3Matters to be reported by a pharmacy proprietor to a prefectural governor that governs the location of the pharmacy pursuant to the provisions of Article 8-2, paragraph (1) of the Act are as in Appended Table 1.
(Basic Information Change Report)
Article 11-4(1)Matters to be reported by a pharmacy proprietor to a prefectural governor that governs the location of the pharmacy pursuant to the provisions of Article 8-2, paragraph (2) of the Act are matters set forth in basic information set forth in row 1, item (1) of Appended Table 1.
(2)The report prescribed in the preceding paragraph is to be delivered via a means specified by the prefectural governor pursuant to the provisions of Article 11-2.
(Means That Makes Use of Information Communication Technology)
Article 11-5(1)In lieu of making documents under Article 8-2, paragraph (1) of the Act pursuant to the provisions of paragraph (3) of the same Article, when providing the matters to be stated in the document by a means that uses electronic data processing systems or other means that makes use of other information communication technology and that is set forth in the following paragraph (hereinafter referred to as "electronic or magnetic means" in this Article), a pharmacy proprietor must, in advance, notify a recipient of medical care of the following types and details of electronic or magnetic means to be used:
(i)any of the means provided in the following paragraph used by the pharmacy proprietor;
(ii)a method of recording the information in a file.
(2)The methods specified by Order of the Ministry of Health, Labour and Welfare provided in Article 8-2, paragraph (3) of the Act are the following:
(i)the means of using electronic data processing systems that connects the computer used by the pharmacy proprietor and the computer used by a recipient of medical care through telecommunication lines (referred to as the "electronic data processing systems" in the following item) and transmit the contents of information through the telecommunication lines and record the information contents onto files on the computer used by the receiver;
(ii)a means that uses the electronic data processing systems, makes the content of information recorded in a file on a computer used by the pharmacy proprietor available to a person receiving medical care via telecommunication lines and records the content of information in a file on a computer used by the recipient of medical care;
(iii)a means to project the content of information recorded in electronic or magnetic records on the screen of an output unit;
(iv)a means to deliver content of information that is recorded on a file prepared using a magnetic disk, CD-ROM, or any other equivalent media on which certain information can be securely recorded.
(Publication of Information)
Article 11-6Pursuant to the provisions of Article 8-2, paragraph (5) of the Act, a prefectural governor must publicize matters reported pursuant to the provisions of paragraphs (1) and (2) of the same Article by the following means:
(i)a means to use the Internet in a format which facilitates retrieval to extract required information and make proper comparison and examination;
(ii)a means to make documents available or to indicate the content of information recorded in electronic or magnetic records on paper or on the screen of an output unit.
(Matters to Be Observed by Pharmacy Proprietors)
Article 11-7Matters to be observed by the pharmacy proprietor specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9, paragraph (1) of the Act are specified in the following Article to Article 15-10.
(Dispensing of Medicine at Pharmacies)
Article 11-8(1)The pharmacy proprietor may not have any person other than a pharmacist engaged in dispensing of medicine dispense medicine for the purpose of the sale or provision thereof at the pharmacy; provided, however, that this does not apply where a pharmacy proprietor of a pharmacy with a work room where an advanced aseptic preparation treatment can be carried out (hereinafter referred to as the "aseptic dispensary room") has a pharmacist who is engaged in dispensing of medicine at a pharmacy without any aseptic dispensary room handle aseptic preparation using the aseptic dispensary room upon a request from a pharmacy proprietor of a pharmacy without any aseptic dispensary room.
(2)In cases prescribed in the proviso of the preceding paragraph, the pharmacy proprietor without such aseptic dispensary room must gain the cooperation of the pharmacy proprietor with such aseptic dispensary room, lay down guidelines, give training to the pharmacist, and take other necessary measures in advance to ensure proper management concerning the aseptic preparation treatment by a pharmacist engaged in dispensing of medicine at the pharmacy without such aseptic dispensary room.
Article 11-9(1)The pharmacy proprietor may not have a pharmacist engaged in dispensing of medicine dispense medicine for the purpose of sale or provision thereof at the pharmacy without any prescription from a medical or dental practitioner or veterinarian.
(2)The pharmacy proprietor may not have a pharmacist engaged in dispensing of medicine at the pharmacy dispense medicine by making any change to the pharmaceutical described in a prescription, except as otherwise agreed to by the medical practitioner, dental practitioner or veterinarian who has issued the prescription.
Article 11-10If a pharmacist engaged in dispensing of medicine at the pharmacy acknowledges there are some doubts in a prescription, a pharmacy proprietor may not have a pharmacist engaged in dispensing of medicine at the pharmacy dispense medicine according thereto without contacting the medical or dental practitioner or veterinarian who has issued the prescription and clearing up the doubts.
Article 11-11A pharmacy proprietor must have a pharmacist engaged in dispensing of medicine at the pharmacy dispense medicine if there is any request for dispensing of medicine; provided, however, that this does not apply in case where there are justifiable grounds.
(Methods of Conducting Tests and Inspections)
Article 12(1)A pharmacy proprietor must have a pharmacy manager undergo tests and inspections of pharmaceuticals that the pharmacy manager finds necessary to appropriately control pharmaceuticals; provided, however, that if the pharmacy manager finds it difficult to conduct tests and inspections by using equipment and instruments at the pharmacy, the pharmacy proprietor may use a test and inspection body registered by the Minister of Health, Labour, and Welfare separately pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare (hereinafter referred to as the "registered test and inspection body") to conduct tests and inspections.
(2)If a test and inspection is conducted pursuant to the provisions of the proviso to the preceding paragraph, a pharmacy proprietor must have a pharmacy manager confirm the results of the test and inspection.
(Books Concerning Administration of Pharmacy)
Article 13(1)A pharmacy proprietor must keep books at the pharmacy to record matters concerning the management of the pharmacy.
(2)A pharmacy manager must indicate the matters concerning tests and inspections, processing of defective products, and other matters concerning the administration of the pharmacy in the books prescribed in the preceding paragraph.
(3)A pharmacy proprietor must maintain the books prescribed in paragraph (1) for three years from the date on which the final description therein was made.
(Records Concerning Acceptance and Transfer of Pharmaceuticals)
Article 14(1)When a pharmacy proprietor receives pharmaceuticals, and sells or provides them to a pharmacy proprietor, holders of marketing authorization for pharmaceuticals, manufacturers or sellers of pharmaceuticals, or an establisher of a hospital, a clinic, or a clinic for domesticated animals (meaning a medical facility provided in Article 2, paragraph (2) of the Veterinary Practice Act (Act No. 46 of 1992) and including the address of a person who has a veterinarian practice medicine for domesticated animals only by visiting them; the same applies hereinafter), the pharmacy proprietor must include the following matters in a document:
(i)the article name;
(ii)quantities;
(iii)the date of reception, sales or provision;
(iv)the name of transferor or transferee.
(2)A pharmacy proprietor must indicate the following matters in writing each time the pharmacy sells or provides pharmacy-only pharmaceuticals, pharmaceuticals requiring guidance or schedule I pharmaceuticals (hereinafter referred to as "pharmacy-only pharmaceuticals, etc." in this paragraph):
(i)the article name;
(ii)quantities;
(iii)the date of sales or provision;
(iv)the name of a pharmacist who sells or provides pharmaceuticals and that of a pharmacist who provides information or instruction under Article 36-4, paragraph (1) of the Act or Article 36-6, paragraph (1) of the Act or provides information under Article 36-10, paragraph (1) of the Act;
(v)results of confirmation that a person who intends to purchase or receive pharmacy-only pharmaceuticals, etc. understands content of the provision of information or instruction under Article 36-4, paragraph (1) of the Act or Article 36-6, paragraph (1) of the Act or the provision of information under Article 36-10, paragraph (1) of the Act.
(3)A pharmacy proprietor must maintain the documents prescribed in paragraph (1) for three years from the day on which the final description is made, and the documents prescribed in the preceding paragraph for two years from the day on which the final description is made.
(4)A pharmacy proprietor must endeavor to indicate and maintain the following matters in writing each time the pharmacy sells or provides schedule II pharmaceuticals or schedule III pharmaceuticals:
(i)the article name;
(ii)quantities;
(iii)the date of sales or provision;
(iv)the name of a pharmacist or a registered sales clerk who sells or provides such pharmaceuticals and the name of a pharmacist or registered sales clerk who provides information pursuant to the provisions of Article 36-10, paragraph (3) of the Act;
(v)results of confirmation that a person who intends to purchase or receive schedule II pharmaceuticals understands content of the provision of information under Article 36-10, paragraph (3) of the Act.
(5)A pharmacy proprietor must endeavor to indicate in writing and maintain the contact information of a person who purchases or receives pharmaceuticals when they are sold or provided.
(Storage of Pharmacy-Only Pharmaceuticals)
Article 14-2A pharmacy proprietor may not store or display pharmacy-only pharmaceuticals in a place other than dispensaries (meaning dispensaries provided in Article 1, paragraph (1), item (ix) of the Regulation for Structure and Equipment for Pharmacies (Order of the Ministry of Health and Welfare No. 2 of 1961)); provided, however, that this does not apply in case of storing pharmaceuticals requiring guidance or OTC pharmaceuticals in a place other than the place where the pharmaceuticals are usually displayed or delivered.
(Closing of Places of Displaying Pharmaceuticals)
Article 14-3(1)A pharmacy proprietor must close a place which usually displays or delivers pharmaceuticals requiring guidance or OCT pharmaceuticals when pharmaceuticals requiring guidance or OCT pharmaceuticals are not sold or provided during the opening hours (meaning business hours excluding the time exclusively for making specified sales; the same applies hereinafter).
(2)A pharmacy proprietor must close a display compartment for pharmaceuticals requiring guidance (meaning a display compartment for pharmaceuticals requiring guidance provided in Article 1, paragraph (1), item (x), (b) of the Regulation for Structure and Equipment for Pharmacies; the same applies hereinafter) or a display compartment for schedule I pharmaceuticals (meaning a display compartment for schedule I pharmaceuticals provided in item (xi), (b) of the same paragraph; the same applies hereinafter) during the time when neither pharmaceuticals requiring guidance nor schedule I pharmaceuticals are sold or provided during business hours; provided, however, that this does not apply where pharmaceuticals requiring guidance or schedule I pharmaceuticals are displayed in a locked display facility (meaning a display facility provided in item (x), (a) of the same paragraph; the same applies hereinafter).
(Categories of Professionals in Pharmacies)
Article 15(1)A pharmacy proprietor must have workers of the pharmacy wear name tags and take other necessary measures so that pharmacists, registered sales clerks, or general workers (meaning persons other than pharmacists or registered sales clerks engaged in practical operations at the pharmacy; the same applies in Article 15-8, paragraph (1) can be easily identified.
(2)A pharmacy proprietor must use notation on the name tags prescribed in the preceding paragraph worn by registered sales clerks who has been engaged in the business operation as a general worker (meaning a person other than a pharmacist and registered sales clerk who is engaged in practical operations in the pharmacy, store, or area) under management and instructions of a pharmacist or a registered sales clerk and has been engaged in operations as a registered sales clerk (including those as store managers or area managers) for less than two years in total in the last five years in pharmacies, store-based distribution or household distribution, so that the same can be easily judged.
(3)A pharmacy proprietor must have the registered sales clerks prescribed in the preceding paragraph engage in practical operations under management and instructions of a pharmacist or a registered sales clerk (excluding the registered sales clerk prescribed in the same paragraph).
(Sales of Pharmaceuticals Suspected to Be Abused)
Article 15-2When a pharmacy sells or provides pharmacy-made pharmaceuticals or OTC pharmaceuticals that are designated by the Minister of Health, Labor and Welfare as those suspected to be abused, etc. (hereinafter referred to as "pharmaceuticals suspected to be abused"), a pharmacy proprietor must conduct the same by any of the following methods:
(i)having a pharmacist or a registered sales clerk engaged in sales or provision of pharmaceuticals at the pharmacy confirm the following matters:
(a)when a person who purchases or receives the pharmaceuticals is young, the name and age of the person;
(b)the situation with respect to purchase or receipt of pharmaceuticals or pharmaceuticals suspected to be abused by a person who intends to purchase or receive the pharmaceuticals and a person who intends to use them from another pharmacy proprietor, a store-based distributor or a household distributor;
(c)the reason why a person who intends to purchase or receive the pharmaceuticals intends to purchase or receive a quantity greater than the one recognized to be necessary for appropriate use;
(d)other matters necessary to censure the pharmaceuticals are purchased or accepted for the appropriate use of the pharmaceuticals;
(ii)having a pharmacist or a registered sales clerk engaged in sales or provision of pharmaceuticals at the pharmacy sell or provide only the quantity recognized as necessary for ensuring the appropriate use of the pharmaceuticals by taking matters confirmed pursuant to the provisions of the preceding item into consideration.
(Prohibition of Sales of Pharmaceuticals Whose Use Limit Is Exceeded)
Article 15-3A pharmacy proprietor may not sell, provide, or store or display or advertise for the purpose of sales or provision pharmaceuticals whose use limit labeled on immediate containers or immediate wrappers is exceeded without legitimate grounds.
(Prohibition of Sales of Pharmaceuticals at Auction)
Article 15-4A pharmacy proprietor may not put pharmaceuticals up for auction.
(Advertisement of Pharmaceuticals at Pharmacies)
Article 15-5(1)In advertising pharmaceuticals to be sold or provided at a pharmacy, a pharmacy proprietor may not label opinions on the pharmaceuticals of those who purchased or received them, or those who used the other pharmaceuticals purchased or received by them or matters that may make the use of pharmaceuticals inappropriate.
(2)A pharmacy proprietor may not advertise pharmaceuticals via a method that solicits the automatic purchase or acceptance of specified pharmaceuticals or other methods that may make the use of other pharmaceuticals appropriate.
(Methods of Specified Sales)
Article 15-6In conducting specified sales, a pharmacy proprietor must conduct the same by any of the following methods:
(i)selling or providing OTC pharmaceuticals or pharmacy-made pharmaceuticals stored or displayed there;
(ii)in advertising specified sales, clearly labeling the information set forth in Appended Tables 1-2 and 1-3 on the website in the utilization of the Internet or on the advertisement in the utilization of other advertisement methods;
(iii)in advertising specified sales, labeling schedule I, designated schedule II, schedule II, and schedule III pharmaceuticals and pharmacy-made pharmaceuticals by criteria;
(iv)in advertising specified sales on the Internet, advertising it on a website so that a prefectural governor and the Minister of Health, Labor and Welfare can easily inspect the same.
(Sales of Designated Schedule II Pharmaceuticals)
Article 15-7In selling or providing designated schedule II pharmaceuticals, a pharmacy proprietor must take necessary measures so that a person who intends to purchase or receive the designated schedule II pharmaceuticals can surely recognize matters set forth in row 2, item 6 of Appended Table 1-2.
(Proof and Records of Practical Operations)
Article 15-8(1)When a person who has engaged in practical operations at the pharmacy as a general worker under the management and instructions of a pharmacist or a registered sales clerk asks for proof of the person's engagement in the practical operations for the past five years, a pharmacy proprietor must immediately prove thereof.
(2)In cases prescribed in the preceding paragraph, a pharmacy proprietor may not give false or wrongful proof.
(3)A pharmacy proprietor must maintain records necessary to give proof prescribed in paragraph (1).
(Proof and Records of Practical Experiences)
Article 15-9(1)When a person who has been engaged in the practical operations as a registered sales clerk at the pharmacy asks for proof of the person's engagement in the operations for the past five years, a pharmacy proprietor must immediately prove thereof.
(2)In cases prescribed in the preceding paragraph, a pharmacy proprietor may not give false or wrongful proof.
(3)A pharmacy proprietor must maintain records necessary to give proof prescribed in paragraph (1).
(Measures for Pharmacists with Impairment of their Visual, Auditory, Speech or Language Faculties)
Article 15-10When a pharmacy proprietor is a pharmacist or a registered sales clerk with visual, auditory, speech or language impairment, or a pharmacist or a registered sales clerk who engages in pharmaceutical practice at the pharmacy has such an impairment, the pharmacy proprietor must install necessary facilities and take other necessary measures in order to avoid the risk of a hazard in health and hygiene.
(Sales of Dispensed Medicines)
Article 15-11A pharmacy proprietor must have a pharmacist engaged in sales or provision of medicines at the pharmacy sell or provide dispensed medicines by any of the following methods pursuant to the provisions of Article 9-2 of the Act:
(i)the pharmacy proprietor has the pharmacist sell or provide medicines after confirming that those who receive information and instruction under Article 9-3, paragraph (1) of the Act understand the details of the provision of information and instruction and have no question;
(ii)if a person who intends to purchase or receive the medicine asks for a consultation, the pharmacy proprietor has the pharmacist sell or provide medicines after the provision of information and instruction under Article 9-3, paragraph (4) of the Act;
(iii)the pharmacy proprietor has a person who intends to sell or receive the medicines give the name of the pharmacist who sells or provides the medicine, and the name and telephone number or other contact information of the pharmacy.
(Methods of Provision of Information and Instruction Concerning Medicines Dispensed)
Article 15-12(1)A pharmacy proprietor must have a pharmacist engaged in sales or provision of medicines at a pharmacy provide information or instruction under Article 9-3, paragraph (1) of the Act by any of the following methods:
(i)a pharmacy proprietor has the pharmacists provide information and instruction at the place for the provision of information and guidance inside the pharmacy (meaning the place of the facilities for the provision of the information and instruction provided in Article 1, paragraph (1), item (xii) of the Regulation for Structure and Equipment for Pharmacies, or a place where medicines are dispensed in cases of dispensing medicines at homes, etc. of the recipients of medical care provided in Article 22 of the Pharmacists Act or in cases of special circumstance provided in the proviso of the same Article);
(ii)a pharmacy proprietor has the pharmacists provide the information required for the appropriate use of the medicine, such as usage, dosage, precautions for the medicine, pharmaceuticals whose simultaneous use with the medicine should be avoided, and others case by case in accordance with a state of a person who purchases or receives the medicine and provide the necessary instruction;
(iii)a pharmacy proprietor has the pharmacists explain the response in case of the occurrence of a symptom which may be side effects of the medicine or caused by another reason;
(iv)a pharmacy proprietor has the pharmacists confirm a person who receives the provision of information and instruction understands the details of the provision of information and instruction and whether the person has any question;
(v)a pharmacy proprietor has the pharmacists give the name of the pharmacist who provides the information and the instruction.
(2)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9-3, paragraph (1) of the Act are as follows; provided, however, that in cases of having a pharmacist engaged in sales or provision of medicines at the pharmacy provide information by using a container or wrapper for dispended medicines which indicates matters provided in Article 25 of the Pharmacists Act, matters set forth in items (i) to (iv) are not required to be indicated:
(i)the name of the medicine;
(ii)the name of active components included in the medicine (its general name if any; the same applies hereinafter) and the quantity (if active components are unknown, a summary of their essential qualities and manufacturing methods; the same applies hereinafter);
(iii)usage and dosage of the medicine;
(iv)efficacy and effect of the medicine;
(v)matters necessary for the purpose of preventing the occurrence of a hazard in health and hygiene in precautions concerning use of the medicines;
(vi)other matters judged by a pharmacist who dispenses the medicine as necessary for the appropriate use.
(3)The method specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9-3, paragraph (1) of the Act is the method of indicating matters recorded in electronic or magnetic records provided in the same paragraph on paper or on the screen of an output device.
(4)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9-3, paragraph (2) of the Act are as follows:
(i)age;
(ii)the situation with respect to use of other medicines or pharmaceuticals;
(iii)gender;
(iv)symptoms;
(v)if a user currently suffers another illness, its name;
(vi)whether a user is pregnant and if so, the number of weeks of pregnancy;
(vii)whether a user is breastfeeding;
(viii)whether a user has an experience of purchase, acceptance, or use concerning the medicine;
(ix)whether the person has suffered from an illness which may be a side effects and others of medicines dispensed or pharmaceuticals, and if the person has, its symptoms, the time, names of the medicine or pharmaceuticals, active components, dosage, and the medication state;
(x)other matters required to be confirmed to provide information and instruction under Article 9-3, paragraph (1) of the Act.
Article 15-13A pharmacy proprietor must have a pharmacist engaged in sales or provision of medicines at the pharmacy provide information or instruction under Article 9-3, paragraph (4) of the Act by any of the following methods:
(i)the pharmacy proprietor has the pharmacist explain matters necessary for the purpose of preventing the occurrence of a hazard in health and hygiene in using the medicine;
(ii)the pharmacy proprietor has the pharmacist provide the information required for the appropriate use of the medicine, such as usage, dosage, precautions for the medicine, pharmaceuticals whose simultaneous use with the medicine should be avoided, and others case by case in accordance with a state of a person who intends to purchase or receive the medicine or purchases or receives the medicine from the establisher or give the necessary instruction;
(iii)the proprietor has the pharmacist give the names of pharmacists who provide the information and the instruction.
(Posting at Pharmacies)
Article 15-14(1)The posting prescribed by the provisions of Article 9-4 of the Act is to be via a bulletin board labeling matters stipulated in the following paragraph:
(2)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 9-4 of the Act are as in Appended Table 1-2:
(Notification of Changes)
Article 16(1)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 10, paragraph (1) of the Act are as follows:
(i)the name or the address of pharmacy proprietor (including the name of an officer responsible for the business operation if the pharmacy proprietor is a corporation);
(ii)the main parts of structure and equipment for the pharmacy;
(iii)normal business days and business hours;
(iv)the name, the address, or working hours per week of a pharmacy manager;
(v)the name or working hours per week of a pharmacist engaged in pharmaceutical practice or a registered sales clerk who engages in pharmaceutical affairs at the pharmacy besides the pharmacy manager;
(vi)types of radioactive pharmaceuticals at the time of handling them;
(vii)types of selling pharmaceuticals or other businesses also carried out at the pharmacy;
(viii)criteria set forth in each item of Article 1, paragraph (3) for pharmaceuticals sold or provided at the pharmacy (excluding changes of only criteria for pharmaceuticals that are subject to specified sales).
(2)The notification under Article 10, paragraph (1) of the Act is to be made by submitting a notification based on Form No. 6; provided, however, that if a pharmacy manager in prescribed in item (iv) of the preceding paragraph receives an order for reeducation and training, the pharmacy manager is to present a registration certificate prescribed in Article 8-2, paragraph (3) of the Pharmacists Act for completion of reeducation or attach its copy.
(3)Documents specified in each of the following items in accordance with criteria for notification set forth therein respectively must be attached to documents prescribed in the preceding paragraph; provided, however, that this does not apply to written documents submitted to a prefectural governor who is in charge of receiving the written applications at the time of application and other acts (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward; hereinafter the same applies in this paragraph) or submitted to the Minister of Health, Labour and Welfare via the prefectural governor, the notification has a supplementary note to that effect:
(i)a notification concerning the name of a pharmacy proprietor set forth in paragraph (1), item (i):certified copy of family register, certified copy of abridged family register, or certificate of family register description of the pharmacy proprietor (certificate of registered information if the proprietor is a corporation);
(ii)a notification concerning an officer set forth in paragraph (1), item (i):doctor's written diagnosis with regard to mental impairment of a new officer or whether or not the officer is addicted to narcotics, cannabis, opium, or stimulants;
(iii)a notification concerning matters set forth in paragraph (1), item (iv) or (v) (excluding cases where a new manager or a pharmacist engaged in pharmaceutical practices or a registered sales clerk engaged in pharmaceutical practice at the pharmacy is a pharmacy proprietor):a copy of an employment agreement and other documents proving an employment relationship with a new manager of the pharmacy proprietor or a new pharmacist engaged in pharmaceutical practice or a new registered sales clerk at the pharmacy.
(4)The applicant may submit a document which shows the officer does not fall under Article 5, item (iii), (e) and (f) of the Act in place of a written diagnosis set forth in item (ii) of the preceding paragraph, if an applicant is a corporation and a prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward) acknowledges business operations are not adversely affected according to the content of the duties of the officer.
Article 16-2(1)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 10, paragraph (2) of the Act are as follows:
(i)the telephone number or other contact information for times of consultation and in emergencies;
(ii)whether specified sales are conducted;
(iii)matters set forth in each item of Article 1, paragraph (4).
(2)The notification under Article 10, paragraph (2) of the Act is to be made by submitting a notification based on Form No. 6.
(3)If a new specified sale is to be conducted at the pharmacy, a document including matters set forth in each of the items in Article 1, paragraph (4) must be attached to the notification prescribed in the preceding paragraph.
(Notification of the Number of Handled Prescriptions)
Article 17(1)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in the proviso of Article 2 of the Order are as follows:
(i)the period when the business operation was conducted in the preceding year is less than three months;
(ii)if the number calculated by dividing the total number of prescriptions handled in the preceding year by the number of working days in the preceding year is 40 or less.
(2)The notification prescribed in Article 2 of the Order is to be made by submitting a notification based on Form No. 7.
(Form for Notification of Suspension or Abolition)
Article 18The notification under Article 10, paragraph (1) of the Act is to be made by submitting a notification based on Form No. 8 if a pharmacy is discontinued, or its business is suspended or is resumed.
Chapter II Marketing and Manufacturing Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics
(Application for License for Marketing Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics)
Article 19(1)In applying for the license for marketing pharmaceuticals (excluding in-vitro diagnostics; hereinafter the same applies in this chapter), quasi-pharmaceutical products or cosmetics prescribed in Article 12, paragraph (1) of the Act, a written application based on Form No. 9 is to be submitted to a prefectural governor who is responsible for activities related to granting the license pursuant to the provisions of Article 80 of the Order (when a pharmacy that markets pharmacy-made pharmaceuticals is located in a city with established health centers or a special ward, the mayor of the city or the head of the special ward; the same applies hereinafter in the following paragraph and paragraph (3), Article 23, paragraph (1), Article 38, Article 46, paragraph (1), Article 48, paragraph (1), Article 70, paragraphs (1) and (2), Article 99, paragraph (3), Article 213, paragraph (1), and Article 228-22).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the written applications at the time of application and other acts or submitted to the Minister of Health, Labour and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)a doctor's written diagnosis with regard to mental impairment of an applicant (if the applicant is a corporation, the officer responsible for the operation; the same applies hereinafter in this item) or whether or not the applicant is addicted to narcotics, cannabis, opium, or stimulants;
(iii)if an applicant has actually obtained a license for marketing, a copy of the license certificate for marketing;
(iv)if an applicant is a corporation, an organizational chart;
(v)if a person other than an applicant is a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics, a copy of an employment agreement and other documents proving an employment relationship between the applicant and the marketing director;
(vi)documents proving that the marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics is a person provided in Article 17, paragraph (1) of the Act;
(vii)documents concerning the system concerning quality control;
(viii)documents concerning the system concerning post-marketing safety control (meaning post-marketing safety control provided in Article 12-2, item (ii) of the Act; the same applies hereinafter).
(3)The applicant may submit a document proving the officer does not fall under Article 5, item (iii), (e) and (f) of the Act in place of a written diagnosis set forth in item (ii) of the preceding paragraph, if an applicant is a corporation and a prefectural governor who is responsible for activities concerning providing the license pursuant to the provisions of Article 80 of the Order acknowledges, judging from duties of the officer, that business operations are not adversely affected.
(4)The provisions of Article 9 apply mutatis mutandis to an application prescribed in paragraph (1).
(Form for License Certificate for Marketing)
Article 20The license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, and cosmetics is to be based on Form No. 10.
(Application for Updated Issuance of License Certificate for Marketing)
Article 21A written application prescribed in Article 5, paragraph (2) of the Order is to be based on Form No. 3.
(Application for Reissuance of License Certificate for Marketing)
Article 22A written application prescribed in Article 6, paragraph (2) of the Order is to be based on Form No. 4.
(Application for Renewal of License for Marketing)
Article 23(1)An application for a renewal of license for marketing pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 12, paragraph (2) of the Act is to be made by submitting a written application based on Form No. 11 to a prefectural governor who is responsible for activities concerning the licensing pursuant to the provisions of Article 80 of the Order.
(2)The license certificate of a license pertaining to the application must be attached to the written application prescribed in the preceding paragraph.
(Matters to Be Included in Registry of License for Marketing)
Article 24Matters to be included in the registry of license prescribed in Article 12, paragraph (1) of the Act provided in Article 8, paragraph (1) of the Order are as follows:
(i)the license number and date;
(ii)the type of license;
(iii)the name and address of the holder of marketing authorization;
(iv)the name and location of the office where the marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics performs the activities (hereinafter referred to as the "office with major functions" in this Chapter);
(v)the name and address of the marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics;
(vi)if the holder of marketing authorization receives another type of license for marketing, the type of the license and the license number.
(Application for License for Manufacturing)
Article 25(1)To apply for the license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 13, paragraph (1) of the Act, a written application based on Form No. 12 (the original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy when submitting to a prefectural governor, the mayor of a city with established health centers or the head of a special ward) is to be filed with the Director of the Regional Bureau of Health and Welfare or a prefectural governor who is responsible for activities concerning the license pursuant to the provisions of Article 281 of this Regulation or Article 80 of the Order (in the case of a pharmacy which manufactures pharmacy-made pharmaceuticals and is located in a city with established health centers or a special ward, the mayor of the city or the head of the special ward; the same applies hereinafter in the following paragraph and paragraph (3), Article 28, paragraph (1), Article 29, paragraph (1), Article 30, paragraph (1), Article 31, and Article 100, paragraph (3)).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Director of the Regional Bureau of Health and Welfare or a prefectural governor who is in charge of receiving the written applications at the time of application and other acts or submitted to the Director of the Regional Bureau of Health and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)documents which show the applicant does not fall under Article 5, item (iii), (e) and (f) of the Act;
(iii)if a person other than an applicant is a manufacturing supervisor of pharmaceuticals or a technical supervisor of quasi-pharmaceutical products, etc., a copy of an employment agreement and other documents proving an employment relationship between the applicant and the manufacturing supervisor of pharmaceuticals or the technical supervisor of quasi-pharmaceutical products;
(iv)documents proving that a manufacturing supervisor of pharmaceuticals is a pharmacist or a person set forth in Article 88 or a technical supervisor of quasi-pharmaceutical products is a person set forth in Article 91;
(v)documents concerning structure and equipment at the manufacturing facility;
(vi)a list of items to be manufactured and documents concerning the manufacturing process;
(vii)documents showing types of radioactive pharmaceuticals and the outline of equipment required to handle radioactive pharmaceuticals when the pharmacy intends to handle radioactive pharmaceuticals (excluding the case where the pharmacy intends to handle radioactive pharmaceuticals that are below the quantity or concentration specified by the Minister of Health, Labour and Welfare);
(viii)if an applicant is granted another license or registration for manufacturing, a copy of the license certificate or the registration certificate for manufacturing.
(3)The provisions of Article 9 apply mutatis mutandis pursuant to an application prescribed in paragraph (1).In this case, "a prefectural governor (... in the case where the location" in Article 9 is deemed to be replaced with "the Director of the Regional Bureau of Health and Welfare or a prefectural governor (in the case where the pharmacy that manufactures pharmacy-made pharmaceuticals".
(License Criteria for Manufacturing)
Article 26(1)The license criteria for manufacturing pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare provided in Article 13, paragraph (2) of the Act are as follows:
(i)type of manufacturing where all or part of the pharmaceutical manufacturing process provided in Article 80, paragraph (2), item (iii), (a), (c), and (d) of the Order is conducted;
(ii)type of manufacturing where all or part of the manufacturing process for radioactive pharmaceuticals (excluding those set forth in the preceding item) is conducted;
(iii)type of manufacturing where all or part of the manufacturing process of aseptic pharmaceuticals (meaning aseptic pharmaceuticals and excluding those set forth in preceding two items; the same applies hereinafter) is conducted (excluding those set forth in item (v));
(iv)type of manufacturing where all or part of the manufacturing process for pharmaceuticals other than those set forth in the preceding three items is conducted (excluding those set forth in the following item);
(v)type of manufacturing where only wrapping, labeling, and storing are conducted in the manufacturing process for pharmaceuticals set forth in the preceding two items.
(2)The license criteria for manufacturing quasi-pharmaceutical products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 13, paragraph (2) of the Act are as follows:
(i)type of manufacturing where all or part of the manufacturing process for aseptic quasi-pharmaceutical products (meaning sterilized quasi-pharmaceutical products; the same applies hereinafter) is conducted (excluding those set forth in item (iii));
(ii)type of manufacturing where all or part of the manufacturing process for quasi-pharmaceutical products other than those set forth in the preceding item (excluding those set forth in the following item) is conducted;
(iii)type of manufacturing where only wrapping, labeling, and storing are conducted in the manufacturing process for quasi-pharmaceutical products.
(3)The license criteria for manufacturing cosmetics specified by Order of the Ministry of Health, Labour and Welfare provided in Article 13, paragraph (2) of the Act are as follows:
(i)type of manufacturing where all or part of the manufacturing process for cosmetics is performed (excluding those set forth in the following item);
(ii)type of manufacturing where only wrapping, labeling, and storing are conducted in the manufacturing process for cosmetics.
(Form for License Certificate for Manufacturing)
Article 27The license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, and cosmetics is to be based on Form No. 13.
(Application for Updated Issuance of License Certificate for Manufacturing)
Article 28(1)A written application prescribed in Article 12, paragraph (2) of the Order (when submitting to the Director of the Regional Bureau of Health and Welfare, two sets of a written application, specifically the original and a duplicate, and when submitting to a prefectural governor, one original) is to be based on Form No. 3.
(2)A fiscal stamp equivalent to the fee must be affixed to a written application which is to be submitted to the Director of the Regional Bureau of Health and Welfare pursuant to the provisions of the preceding paragraph.
(Application for Reissuance of License Certificate for Manufacturing)
Article 29(1)A written application prescribed in Article 13, paragraph (2) of the Order (when submitting to the Director of the Regional Bureau of Health and Welfare, two sets of a written application, specifically the original and a duplicate, and when submitting to a prefectural governor, one original) is to be based on Form No. 4.
(2)A fiscal stamp equivalent to the fee must be affixed to a written application which is to be submitted to the Director of the Regional Bureau of Health and Welfare pursuant to the provisions of the preceding paragraph.
(Application for Renewal of License for Manufacturing)
Article 30(1)An application for a renewal of license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 13, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 14 (an original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy when submitting to a prefectural governor) to the Director of the Regional Bureau of Health and Welfare or a prefectural governor, who are respectively responsible for activities concerning the license pursuant to the provisions of Article 281 of this Regulation or Article 80 of the Order.
(2)The license certificate of a license pertaining to the application must be attached to the written application prescribed in the preceding paragraph.
(Application for Changes in License Criteria for Manufacturing)
Article 31(1)To apply for a license for changes or additions to the license criteria for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 13, paragraph (6) of the Act, a written application based on Form No. 15 (an original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy when submitting to a prefectural governor) is to be filed with the Director of the Regional Bureau of Health and Welfare or a prefectural governor, who are respectively responsible for activities concerning the license pursuant to the provisions of Article 281 of this Regulation or Article 80 of the Order.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Director of the Regional Bureau of Health and Welfare or a prefectural governor who is in charge of receiving the written applications at the time of application and other acts or submitted to the Director of the Regional Bureau of Health and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)a license certificate;
(ii)a list of items to be manufactured concerning changes or additions and documents concerning a manufacturing process;
(iii)documents concerning structure and equipment of a manufacturing facility concerning the license criteria to be changed or added.
(Matters to Be Included in Registry of License for Manufacturing)
Article 32Matters to be included in the registry of license prescribed in Article 13, paragraphs (1) and (6) of the Act provided in Article 15, paragraph (1) of the Order are as follows:
(i)the license number and date;
(ii)the license criteria;
(iii)the name and address of the holder of license for manufacturing;
(iv)the name and location of the manufacturing facility;
(v)the name and address of a manufacturing supervisor of pharmaceuticals or a technical supervisor of quasi-pharmaceutical products at the manufacturing facility;
(vi)if the manufacturer is granted another license or registration for manufacturing, the criteria and the license number or registration number for the manufacturing license.
(Application for Investigation Concerning License for Manufacturing or Renewal of License to the Pharmaceuticals and Medical Devices Agency)
Article 33(1)When it is determined to have the Pharmaceuticals and Medical Devices Agency (hereinafter referred to as the "PMDA") undergo the investigation provided in Article 13, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) pursuant to the provisions of Article 13-2, paragraph (1) of the Act, an applicant for license prescribed in Article 13, paragraph (1) or (6) of the Act concerning pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 16 of the Order or renewal of license prescribed in paragraph (3) of the same Article must apply for the investigation to the PMDA.
(2)When filing the application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 16 to a written application for license of items concerning the application prescribed in Article 13, paragraph (1) or (6) of the Act or renewal of license prescribed in paragraph (3) of the same Article and carry out the application via the Director of the Regional Bureau of Health and Welfare.
(Notification of Results of Investigation Concerning License for Manufacturing or Renewal of License by the PMDA)
Article 34The notification of results of the investigation under Article 13-2, paragraph (4) of the Act is to be given by a notification based on Form No. 17 to the Director of the Regional Bureau of Health and Welfare.
(Application for Accreditation of Foreign Manufacturer of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 35(1)An application for accreditation of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics prescribed in Article 13-3, paragraph (1) of the Act is to be made by submitting written applications based on Form No. 18 (the original and a duplicate).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)documents which show the applicant (an officer responsible for the business if the applicant is a corporation)does not fall under Article 5, item (iii), (e) and (f) of the Act;
(ii)a resume of a person in charge of the manufacturing facility;
(iii)a list of items to be manufactured and documents concerning the manufacturing process;
(iv)documents concerning structure and equipment at the manufacturing facility;
(v)when the pharmacy intends to deal with radioactive pharmaceuticals (excluding the case where the pharmacy intends to handle radioactive pharmaceuticals below the quantity or concentration specified by the Minister of Health, Labour and Welfare), documents showing the types of radioactive pharmaceuticals and the outline of equipment required to handle radioactive pharmaceuticals;
(vi)if a country where the foreign manufacturer exists has a system of marketing license, manufacturing license, marketing approval of pharmaceuticals, quasi-pharmaceutical products, or cosmetics, or a system corresponding to the same, a copy of a license certificate, etc. issued by a governmental organization of the country.
(Accreditation Criteria of Foreign Manufacturers of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 36(1)The accreditation criteria of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics for the pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare provided in Article 13-3, paragraph (2) of the Act are as follows:
(i)foreign manufacturer that conducts all or part of the pharmaceutical manufacturing process provided in Article 80, paragraph (2), item (iii), (a), (c), and (d) of the Order;
(ii)foreign manufacturer that conducts all or part of the manufacturing process for radioactive pharmaceuticals (excluding those set forth in the preceding item);
(iii)foreign manufacturer that conducts all or part of the manufacturing process for aseptic pharmaceuticals (excluding those set forth in item (v));
(iv)foreign manufacturer that conducts all or part of the manufacturing process for pharmaceuticals other than those set forth in the preceding three items (excluding those set forth in the following item);
(v)foreign manufacturer that conducts only wrapping, labeling, and storing in the manufacturing process for pharmaceuticals set forth in the preceding two items.
(2)The accreditation criteria of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics for the quasi-pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare provided in Article 13-3, paragraph (2) of the Act are as follows:
(i)foreign manufacturer that conducts all or part of manufacturing process for aseptic quasi-pharmaceutical products (excluding those set forth in item (iii));
(ii)foreign manufacturer that conducts all or part of the manufacturing process for quasi-pharmaceutical products other than aseptic ones (excluding those set forth in the following item);
(iii)foreign manufacturer that conducts only wrapping, labeling, and storing in the manufacturing process for quasi-pharmaceutical products.
(Application, Mutatis Mutandis)
Article 37(1)In cases of an accreditation prescribed in Article 13-3, paragraph (1) of the Act or Article 13, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act, or renewal of an accreditation prescribed in Article 13, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act, the provisions of Articles 27 to 34 apply mutatis mutandis.
(2)In cases prescribed in the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms and phrases set forth in the middle column of the same table are deemed as being replaced with the terms and phrases set forth in the right-hand column of that table.
Article 27
license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, and cosmetics
accreditation certificate for foreign manufacturer of pharmaceuticals, etc.
Form No. 13
Form No. 19
Article 28, paragraph (1)
Article 12, paragraph (2)
Article 18-2, paragraph (2)
when submitting to the Director of the Regional Bureau of Health and Welfare, the original and a duplicate, and when submitting to a prefectural governor, the original
The original and a duplicate
Article 28, paragraph (2)
the Director of the Regional Bureau of Health and Welfare
the Minister of Health, Labour and Welfare
Article 29, paragraph (1)
Article 13, paragraph (2)
Article 18-3, paragraph (2)
when submitting to the Director of the Regional Bureau of Health and Welfare, the original and a duplicate, and when submitting to a prefectural governor, the original
the original and a duplicate
Article 29, paragraph (2)
the Director of the Regional Bureau of Health and Welfare
The Minister of Health, Labour and Welfare
Article 30, paragraph (1)
Act
Act as applied mutatis mutandis in pursuant to Article 13-3, paragraph (3) of the Act
license for manufacturing pharmaceuticals, quasi-pharmaceutical products, and cosmetics
accreditation prescribed in Article 13-3, paragraph (1) of of the Act (hereinafter referred to as the "accreditation of a foreign manufacturer of pharmaceuticals, etc.")
Form No. 14
Form No. 20
an original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy when submitting to a prefectural governor are filed with the Director of the Regional Bureau of Health and Welfare or a prefectural governor, who are respectively responsible for activities concerning the license pursuant to the provisions of Article 281 or Article 80 of the Order.
The original and a duplicate to the Minister of Health, Labour and Welfare
Article 30, paragraph (2)
license certificate for license
accreditation certificate for accreditation
Article 31, paragraph (1)
Act
the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act
licenses for manufacturing pharmaceuticals, quasi-pharmaceutical products, and cosmetics
accreditation of foreign manufacturer of pharmaceuticals, etc.
additions to the license
additions to the accreditation
Form No. 15
Form No. 21
an original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy when submitting to a prefectural governor are filed with the Director of the Regional Bureau of Health and Welfare or a prefectural governor, who are respectively responsible for activities concerning the license pursuant to the provisions of Article 281 or Article 80 of the Order.
The original and a duplicate to the Minister of Health, Labour and Welfare
Parts other than listed in each item of Article 31, paragraph (2)
submitted to the Director of the Regional Bureau of Health and Welfare or a prefectural governor who is in charge of receiving the written applications ..., or the Director of the Regional Bureau of Health and Welfare via a prefectural governor
the Minister of Health, Labour and Welfare
Article 31, paragraph (2), , item (i)
A license certificate
An accreditation certificate
Article 31, paragraph (2), item (iii)
license
accreditation
Parts other than listed in each of the items in Article 32
license prescribed in Article 13, paragraphs (1) and (6) of the Act provided in Article 15, paragraph (1)
accreditation prescribed in Article 13-3, paragraph (1) of the Act and Article 13, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act provided in Article 18-5
Article 32, item (i)
The license number and date
The accreditation number and date
Article 32, item (ii)
license
accreditation
Article 32, item (iii)
holder of license for manufacturing
foreign manufacturer of pharmaceuticals, etc.
Article 32, item (v)
manufacturing supervisor of pharmaceuticals or a technical supervisor of quasi-pharmaceutical products
responsible person
Article 32, item (vi)
holder of license for manufacturing
foreign manufacturer of pharmaceuticals, etc.
a license or registration for manufacturing
accreditatation for a foreign manufacturer of pharmaceuticals, etc., or a foreign manufacturer of regenerative medicine products, or registration of foreign manufacturer of medical devices, etc.
criteria and license number for manufacturing license
criteria and accreditation number for accreditation
Article 33, paragraph (1)
Article 13-2, paragraph (1)
Article 13-2, paragraph (1) of the Act, as applied mutatis mutandis pursuant to Article 13-3, paragraph (3)
Article 13, paragraph (5)
Article 13, paragraph (5) of the Act , as applied mutatis mutandis pursuant to Article 13-3, paragraph (3)
license prescribed in Article 13, paragraph (1) or (6) or license prescribed in paragraph (3) of the same Article
accreditation prescribed in Article 13-3, paragraph (1) or Article 13, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) or accreditation prescribed in Article 13, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act
Article 33, paragraph (2)
license prescribed in Article13, paragraphs (1) or (6) or license prescribed in paragraph (3) of the same Article
accreditation prescribed in Article 13-3, paragraph (1) or Article 13, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) or accreditation prescribed in Article 13, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act
Article 34
Act
Act as applied mutatis mutandis pursuant to Article 13-3, paragraph (3) of the Act
the Director of the Regional Bureau of Health and Welfare
the Minister of Health, Labour and Welfare
(Application for Marketing Approval for Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics)
Article 38(1)An application for marketing approval for pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 14, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 22 (an original copy and two duplicate copies when submitting to the Director of the Regional Bureau of Health and Welfare, and an original copy and a duplicate copy when submitting to a prefectural governor)
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare or a prefectural governor who is in charge of receiving the written applications at the time of application and other acts or submitted to the Minister of Health, Labour and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)a copy of a license certificate for marketing concerning the items;
(ii)documents clearly indicating that items to be marketed by an applicant are pharmaceuticals provided in Article 14-3, paragraph (1), item (ii) of the Act when applying for an approval prescribed in Article 14, paragraph (1) of the Act pursuant to the provisions of Article 14-3, paragraph (1) of the Act and other necessary documents.
(Cases Where Products Are Inappropriate for Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics)
Article 39(1)Cases where pharmaceuticals or quasi-pharmaceutical products are specified by Order of the Ministry of Health, Labour and Welfare as not being appropriate as those prescribed in Article 14, paragraph (2), item (iii), (c) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article; the same applies in the following paragraph) are the cases where properties or qualities of pharmaceuticals or quasi-pharmaceutical products concerning the application are remarkably inappropriate with regard to health and hygiene.
(2)Cases where cosmetics are specified by Order of the Ministry of Health, Labour and Welfare as not being appropriate as those prescribed in Article 14, paragraph (2), item (iii), (c) of the Act are the cases where properties and qualities of cosmetics concerning the application are remarkably inappropriate with regard to health and hygiene, and components included in the cosmetics concerning the application are inappropriate as components whose names are not indicated pursuant to the provisions of Article 61, item (iv) of the Act.
(Data to Be Attached to Written Applications for Approval)
Article 40(1)Data to be attached to a written application prescribed in Article 38, paragraph (1) or Article 46, paragraph (1) pursuant to the provisions of Article 14, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) is data set forth in each of the following items according to the approval criteria set forth in those items, and types of active components, routes of administration, and formulations, etc. of pharmaceuticals, quasi-pharmaceutical products, or cosmetics:
(i)approval of pharmaceuticals: the following data:
(a)data concerning origin or background of discovery and conditions of use in foreign countries, etc.;
(b)data concerning manufacturing methods, standards and test methods, etc.;
(c)data concerning stability;
(d)data concerning pharmacological effects;
(e)data concerning absorption, distribution, metabolism, and excretion;
(f)data concerning acute, subacute, and chronic toxicities, genotoxicity, teratogenicity, and other toxicities;
(g)data concerning test results of clinical studies, etc.;
(h)data concerning matters to be indicated on package inserts provided in Article 52, paragraph (1) of the Act;
(ii)an approval of quasi-pharmaceutical products: the following data:
(a)data concerning origin or background of discovery and conditions of use in foreign countries, etc.;
(b)data concerning physical and chemical properties, standards, and test methods, etc.;
(c)data concerning stability;
(d)data concerning safety;
(e)data concerning efficacy or effect;
(iii)approval of cosmetics: the following data:
(a)data concerning origin or background of discovery and conditions of use in foreign countries, etc.;
(b)data concerning physical and chemical properties, etc.;
(c)data concerning safety.
(2)Notwithstanding the provisions of the preceding paragraph, with respect to the data to be attached to written applications prescribed in Article 38, paragraph (1) or Article 46, paragraph (1) pursuant to provisions of Article 14, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article), if it is recognized that matters concerning the application are well known in the medical and pharmaceutical fields, or there are other reasonable grounds why the attachment of data is not required, the attachment is not required; provided, however, that it is not recognized that pharmaceuticals are well known in the medical and pharmaceutical fields if their active components, quantities, usages, dosages, indications, and efficacies are same as those of new pharmaceuticals provided in Article 14-4, paragraph (1), item (i) of the Act excluding pharmaceuticals requiring attachment of data in an application for approval of the new pharmaceuticals while the new pharmaceuticals are being reexamined.
(3)A test required to create data set forth in each item of paragraph (1) must be conducted at a test facility, etc. that has a facility, devices, and employees required to ensure the reliability of test results and is recognized to be properly operated and managed.
(4)When the data casts a doubt on whether pharmaceuticals, quasi-pharmaceutical products, and cosmetics pertaining to an application have sufficient quality, efficacy, or safety pertaining to the application, an applicant must submit the data to the Minister of Health, Labour and Welfare and a prefectural governor even if the test required to create the data has not been conducted at a test facility, etc. provided in the preceding paragraph.
(5)Beyond what is set forth in each item of paragraph (1) and provided in the preceding paragraph, if the Minister of Health, Labour and Welfare or a prefectural governor acknowledges the necessity of pharmaceuticals, quasi-pharmaceutical products, or cosmetics concerning the examination for approval and asks for the submission of samples of pharmaceuticals, quasi-pharmaceutical products, or cosmetics and other data, an applicant must submit the data to the minister or the governor.
(Suspension of Submission of Data to Be Attached to Written Application for Approval of Pharmaceuticals Concerning Special Approval)
Article 41With regard to the pharmaceuticals to be marketed by an applicant with an approval prescribed in Article 14 of the Act under Article 14-3, paragraph (1) of the Act, when the applicant acknowledges that data set forth in paragraph (1), item (i), (a) through (f) and (h) of the preceding Article cannot be attached, the Minister of Health, Labour and Welfare may suspend the submission for a reasonable period of time.
(Pharmaceuticals for Which Data Is Collected and Prepared According to Standards Specified by the Minister of Health, Labour and Welfare)
Article 42Pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare prescribed in the second sentence of Article 14, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) are pharmaceuticals provided in Article 14, paragraph (1) of the Act (excluding pharmaceuticals that can stick on human or animal skins, pharmacy-made pharmaceuticals, those that a prefectural governor is responsible for activities belonging to the approving authority pursuant to the provisions of Article 80 of the Order and those whose purpose is solely to be used for animals).
(Standards of Reliability of Application Data)
Article 43Data provided in the second sentence of Article 14, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) must be collected and prepared via the following means beyond those specified by the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 21 of 1997) and the Ministerial Order on Standards for Clinical Studies of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 28 of 1997):
(i)the data is correctly prepared based on results of the investigation or the test conducted for the purpose of preparing the data;
(ii)if results of the investigation or the test in the preceding item cast a doubt on whether pharmaceuticals pertaining to an application have sufficient quality, efficacy, or safety for the application, results of the investigation and the test are reviewed and evaluated and the results are described in the data;
(iii)data on which the data is based is preserved until the date of disposition when the approval prescribed in Article 14, paragraph (1) or (9) of the Act is provided or not provided; provided, however, that this does not apply to the case where it is recognized that the nature of the data makes it extremely difficult to preserve.
Article 44Deletion
(Data That Can Be Replaced with Documents Certifying Registration in Drug Master File)
Article 45A person who intends to apply for an approval prescribed in Article 14, paragraph (1) or (9) of the Act may replace a part of data set forth in Article 40, paragraph (1), item (i), (b) through (d) from among the data prescribed in Article 14, paragraph (3) of the Act with a copy of a registration certificate prescribed in Article 280-4, paragraph (1) and an agreement with a person who has obtained registration prescribed in Article 80-6, paragraph (1) of the Act regarding the active ingredients, etc. (hereinafter referred to as a "registered manufacturer of active ingredients, etc.") and other documents certifying the use of the active ingredients, etc. as items pertaining to the application.
(Approval of Partial Change of Approved Matters)
Article 46(1)An application for an approval of partial changes of marketing approval of pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 14, paragraph (9) of the Act is to be made by submitting a written application based on Form No. 23 (the original copy and two duplicates when submitting to the Director of the Regional Bureau of Health and Welfare, and the original copy and a duplicate copy when submitting to a prefectural governor)
(2)To apply for an approval prescribed in Article 14, paragraph (9) of the Act pursuant to the provisions of Article 14-3, paragraph (1) of the Act, documents set forth in Article 38, paragraph (2), item (ii) must be attached to a written application in the preceding paragraph.
(Scope of Minor Changes to Approved Matters)
Article 47Minor changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 14, paragraph (9) of the Act are those other than those set forth in each of the following items:
(i)changes to manufacturing methods, etc. influencing essential qualities, features, or safety of the item;
(ii)deletion of matters set forth in the standard and the test method and changes of the standard;
(iii)changes concerning inactivation or removal method of pathogenic factors;
(iv)addition, change, or deletion to/of usages, dosages, efficacies, or effects;
(v)beyond changes set forth in each of the preceding items, those that may influence the quality, efficacy, or safety of the product.
(Notification of Minor Changes)
Article 48(1)A notification under Article 14, paragraph (10) of the Act is to be given by filing a notification based on Form No. 24 (the original and a duplicate) to the Minister of Health, Labour and Welfare (a prefectural governor if the prefectural governor is responsible for activities concerning the authority provided in Article 14, paragraph (10) of the Act pursuant to the provisions of Article 80 of the Order).
(2)The notification prescribed in the preceding paragraph must be within 30 days after minor changes prescribed in Article 14, paragraph (9) of the Act.
(3)In applying the provisions of paragraph (1) when the Minister of Health, Labour and Welfare decides to have the PMDA undergo a compliance examination on pharmaceuticals, etc. provided in Article 14-2, paragraph (1) of the Act pursuant to the provisions of Article 14-2, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 19-2, paragraphs (5) and (6) of the Act), the term "Minister of Health, Labour and Welfare (a prefectural governor if the governor is responsible for activities which belong to the authority provided in Article 14, paragraph (10) of the Act pursuant to the provisions of Article 80 of the Order)" in the same paragraph is deemed to be replaced with "PMDA".
(Matters to Be Included in Registry of Approval)
Article 49Matters to be included in the registry of approval prescribed in Article 14, paragraphs (1) and (9) of the Act provided in Article 19, paragraph (1) of the Order are as follows:
(i)the approval number and date;
(ii)the name and address of a person who obtained an approval;
(iii)the type and license number for the marketing license of a person who obtained an approval;
(iv)the name and location of the manufacturing facility of the item;
(v)the criteria and license number for a license for manufacturers, or the criteria and accreditation number for an accreditation for foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics received by a manufacturing facility of the item;
(vi)the name of the item;
(vii)the component and quantity of the item;
(viii)the efficacy, effect, or purpose of use of the item;
(ix)the usage and the dosage of the item;
(x)the standard and the test method of the item.
(Application for Compliance Investigation of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 50(1)The application for the investigation prescribed in Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) (hereinafter referred to as the "compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics" in this chapter) is to conducted by submitting a written application based on Form No. 25 to the Minister of Health, Labour and Welfare (a prefectural governor if it is the governor that should engage in activities belonging to the authority of the investigation pursuant to the provisions of Article 80 of the Order).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph:
(i)data concerning the manufacturing and the quality management of the item concerning a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics;
(ii)data concerning the manufacturing and quality management of the manufacturing facility concerning a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics.
(3)In applying the provisions of paragraph (1), when the Minister of Health, Labour and Welfare decides to have the PMDA undergo a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics pursuant to the provisions of Article 14-2, paragraph (1) of the Act, the term "the Minister of Health, Labour and Welfare (a prefectural governor if it is the governor that should engage in activities belonging to the authority of the investigation pursuant to the provisions of Article 80 of the Order)" in the same paragraph is deemed to be replaced with "the PMDA".
(Notification of Results of Compliance Investigations of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 51A notification of the results of compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics to be given by a person conducting a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics (meaning a person conducting a compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 23 of the Order) to a person granting licenses for marketing pharmaceuticals, quasi-pharmaceutical products or cosmetics (meaning a person granting licenses for marketing pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in the same Article) or a person granting approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics (meaning a person granting approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in the same Article) pursuant to the provisions of the same Article is to be given by using a written notice based on Form No. 26; provided, however, that the notification to the Minister of Health, Labour and Welfare, the PMDA is to substitute a notification of results provided in Article 55, paragraph (2) for this.
(Matters to Be Included in Registry of Compliance Investigation of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 52Matters to be included in the registry concerning compliance investigation of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 24, paragraph (1) of the Order are as follows:
(i)investigation results and notification date;
(ii)the name of the item;
(iii)the name and address of a person who intends to receive or has received a marketing approval for the item;
(iv)the approval number and date (limited to the case where the person set forth in the preceding item has already obtained the marketing approval of the item);
(v)the name and location of the manufacturing facility;
(vi)the name and the address of a holder of a license for manufacturing or a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics;
(vii)the license number and license date of the license for manufacturing received by manufacturer prescribed in the preceding item, or the accreditation number and accreditation date of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics.
(Changes of Approved Matters without Compliance Investigation of Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 53Changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 25, paragraph (1) of the Order do not influence the additions, changes, or deletions to/of usages, dosage, efficacy, or effects and other methods to control manufacturing or the quality of the item.
(Application to the PMDA for Examination or Investigation of Marketing Approval of Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics)
Article 54(1)When it is determined to have the PMDA undergo an examination for approval prescribed in Article 14 of the Act pursuant to the provisions of Article 14-2, paragraph (1) of the Act, an applicant for approval prescribed in Article 14, paragraph (1) or (9) of the Act concerning pharmaceuticals, quasi-pharmaceutical products, or cosmetics provided in Article 27, paragraph (1) of the Order must apply to the PMDA for the examination.
(2)When it is determined to have the PMDA undergo the investigation prescribed in the second sentence of Article 14, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) pursuant to the provisions of Article 14-2, paragraph (1) of the Act, an applicant for the approval prescribed in Article 14, paragraph (1) or (9) of the Act concerning pharmaceuticals provided in Article 27, paragraph (1) of the Order and also provided in Article 42 must apply to the PMDA for the investigation.
(3)The applications prescribed in the preceding two paragraphs are to be conducted by attaching a written application based on Form No. 27 to a written application for approval prescribed in Article 14, paragraph (1) or (9) of the Act of the item concerning the application.
(4)The provisions of Article 40, paragraph (5) apply mutatis mutandis to the examination for approval prescribed in Article 14 of the Act and investigation prescribed in paragraph (5) of the same Article (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) (hereinafter referred to as "examination, etc. on pharmaceuticals, etc." in the following Article) pursuant to the provisions of Article 14-2, paragraph (1) of the Act.In this case, "beyond those set forth in each of the items of paragraph (1) and those provided in the preceding paragraph, the Minister of Health, Labour and Welfare or a prefectural governor" is deemed to be replaced with "the PMDA", "examination" with "examination or an investigation prescribed in Article 14, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article)", and "Minister of Health, Labour and Welfare or a prefectural governor" with "Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Examination on Pharmaceuticals, etc. by the PMDA)
Article 55(1)A notification of results of an examination, etc. on pharmaceuticals, etc. to be given pursuant to the provisions of Article 14-2, paragraph (5) of the Act, is to be given to the Minister of Health, Labour and Welfare by using a notification based on Form No. 28.
(2)A notification of results of an investigation prescribed in Article 14, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) to be given pursuant to the provisions of Article 14-2, paragraph (5) of the Act, is to be given to the Minister of Health, Labour and Welfare by using a notification based on Form No. 26.
(3)Notice of a notification status prescribed in Article 14, paragraph (10) of the Act to be given pursuant to the provisions of Article 14-2, paragraph (5) of the Act, is to be given to the Minister of Health, Labour and Welfare by using a notification based on Form No. 29.
(Application for Reexamination on New Pharmaceuticals)
Article 56Application for a reexamination on pharmaceuticals set forth in each of the items in Article 14-4, paragraph (1) of the Act under the same paragraph is to be made by submitting a written application based on Form No. 30 (the original copy and two duplicates).
(Pharmaceuticals Specified by Order of the Ministry of Health, Labour and Welfare Concerning Investigation Period on Reexamination)
Article 57(1)Pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare provided in Article 14-4, paragraph (1), item (i), (a) of the Act are those other than orphan drugs for which investigations on diseases, disability, or death that are suspected to be caused by side effects of the pharmaceuticals, or infectious diseases that are suspected to be caused by the use of the pharmaceuticals (hereinafter referred to as "side effects, etc." in Articles 62 and 63) and other results of usage are found to be required for more than six years since the day of approval for marketing.
(2)Pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare provided in Article 14-4, paragraph (1), item (i), (b) of the Act are pharmaceuticals whose usage (excluding the routes of administration) or dosage are obviously different from those that have obtained a marketing approval, those with same active components and routes of administration (excluding pharmaceuticals set forth in (a) of the same item), and pharmaceuticals recognized as those which have minor differences from those that have obtained an approval for their marketing (excluding pharmaceuticals set forth in (a) of the same item).
Article 58Deleted
(Data to Be Attached to Written Applications for Reexamination)
Article 59(1)Data to be attached to a written application prescribed in Article 56 pursuant to the provisions of Article 14-4, paragraph (4) of the Act are those concerning the results of usage of pharmaceuticals pertaining to the application, the summary of data submitted at the time of reporting under Article 63, paragraph (2) and other data concerning research report on the efficacy, effect and safety of the pharmaceuticals obtained after the marketing approval.
(2)The provisions of Article 40, paragraph (3) apply mutatis mutandis to the data prescribed in the preceding paragraph.
(3)The provisions of Article 40, paragraph (4) apply mutatis mutandis to an applicant for the reexamination prescribed in Article 14-4, paragraph (1) of the Act.In this case, "Minister of Health, Labour and Welfare or a prefectural governor" is deemed to be replaced with "Minister of Health, Labour and Welfare".
(4)Beyond materials provided in Article 40, paragraph (4) as applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph, if the Minister of Health, Labour and Welfare acknowledges it necessary to reexamine pharmaceuticals, and asks for submission of data, an applicant must submit the data to the Minister of Health, Labour and Welfare.
(Scope of Pharmaceuticals Concerning Investigations on Reexamination)
Article 60Pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare prescribed in the second sentence of Article 14-4, paragraph (4) of the Act are those set forth in each of the items of paragraph (1) of the same Article.
(Standards of Reliability of Application Documents for Reexamination)
Article 61The provisions of Article 43 apply mutatis mutandis to the data in the second sentence in Article 14-4, paragraph (4) of the Act.In this case, "the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Pharmaceuticals (Order of the Ministry of Health, Labour and Welfare No. 21 of 1997)" in the same Article is deemed to be replaced with "the Ministerial Order on Standards for Post-Marketing Surveillance and Test of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 171 of 2004), the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 21 of 1997)" and "the date of disposition whether an approval prescribed in Article 14, paragraph (1) or (9) of the Act is given or not" with the "final date of the reexamination prescribed in Article 14-4, paragraph (1) of the Act".
(Investigation on Results of Usage of New Pharmaceuticals and Report of Results)
Article 62(1)Investigations prescribed in Article 14-4, paragraph (6) of the Act to be conducted by persons approved for pharmaceuticals set forth in the following items (excluding pharmaceuticals specified by the Minister of Health, Labour and Welfare as pharmaceuticals used with prescriptions or guidance (hereinafter referred to as " pharmaceuticals used with prescriptions or guidance")) pursuant to the provisions of Article 14 of the Act are to be conducted on side effects, etc. of the pharmaceuticals and other results of usage for the period specified in those items:
(i)new pharmaceuticals provided in Article 14-4, paragraph (1), item (i) of the Act:the investigation period specified in the same item (the extended period if the period has been extended under paragraph (2) of the same Article);
(ii)pharmaceuticals instructed by the Minister of Health, Labour and Welfare pursuant to the provisions of Article 14-4, paragraph (1), item (ii) of the Act:from the day when a marketing approval for them is obtained to the day preceding the first day of the period instructed by the Minister of Health, Labour and Welfare specified in the same item.
(2)The report to the Minister of Health, Labour and Welfare under Article 14-4, paragraph (6) of the Act or the report to the PMDA under the first sentence of Article 14-5, paragraph (2) of the Act is to cover the following matters:
(i)the name of the pharmaceuticals;
(ii)the approval number and date;
(iii)the investigation period and the number of investigated cases;
(iv)the shipping quantity of the pharmaceuticals;
(v)the summary and analysis results of investigation results;
(vi)the expression status of side effects, etc. classified by category;
(vii)the list of expression cases of side effects, etc.
(3)The reports prescribed in the preceding paragraph must be made annually (in case of pharmaceuticals instructed by the Minister of Health, Labour and Welfare, the period instructed by the Minister) from the date when marketing pharmaceuticals concerning the investigation is approved, within two months after the expiry of the period.
(4)A notification of receiving a report prescribed in paragraph (2) to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of the second sentence of Article 14-5, paragraph (2) of the Act is to be given by using a notification based on Form No. 31.
(Regular Safety Report)
Article 63(1)Investigations prescribed in Article 14-4, paragraph (6) of the Act to be conducted by persons who have obtained an approval prescribed in Article 14 of the Act for pharmaceuticals used with prescriptions or guidance falling under each of the items of paragraph (1) of the preceding Article are to be conducted on the expression status of side effects to the pharmaceuticals used with prescriptions or guidance, and other results of usage (including those pertaining to the pharmaceuticals in case of those used in a foreign country with the same components as the pharmaceuticals used with prescriptions or guidance (hereinafter referred to as "pharmaceuticals with same components") for the period specified in each of the items of paragraph (1) of the preceding Article.
(2)A report to the Minister of Health, Labour and Welfare under Article 14-4, paragraph (6) of the Act or a report to the PMDA under the first sentence of Article 14-5, paragraph (2) of the Act is to cover the following matters:
(i)the name of the pharmaceuticals used with prescriptions or guidance or the pharmaceuticals with same components (hereinafter referred to as the "pharmaceuticals used with prescriptions or guidance, etc.");
(ii)the approval day and number (in cases of pharmaceuticals with same components, the date when manufacture or sales are approved in the foreign country);
(iii)the investigation period and the number of investigated cases;
(iv)the shipping quantity of the pharmaceuticals used with prescriptions or guidance, etc.;
(v)the summary and analysis results of investigation results;
(vi)the expression status of side effects classified by category of the pharmaceuticals used with prescriptions or guidance, etc.;
(vii)the expression status of side effects, etc. to the pharmaceuticals used with prescriptions or guidance, etc.;
(viii)measures taken to prevent the occurrence or spread of a hazard in health and hygiene or expansion of the same caused by the pharmaceuticals used with prescriptions or guidance, etc., or for the appropriate use of the pharmaceuticals used with prescriptions or guidance, etc.;
(ix)the inserts for the pharmaceuticals used with prescriptions or guidance, etc.;
(x)matters related to the quality, efficacy, and safety of the pharmaceuticals used with prescriptions or guidance, etc. and other information required for the appropriate use of the pharmaceuticals used with prescriptions or guidance, etc.
(3)The report prescribed in the preceding paragraph must be made every half year for two years from the date designated by the Minister of Health, Labour and Welfare at the time of marketing approval of pharmaceuticals related to the investigation, and after that, annually (in cases of pharmaceuticals instructed by the Minister of Health, Labour and Welfare at intervals instructed by the Minister) within 70 days (three months if data obtained in the investigation prescribed in paragraph (1) is written in non-Japanese languages) after the expiry of the period.
(4)If the expiry date for the period provided in the preceding paragraph (hereinafter referred to as the "deadline for report") is after the expiry date of the period provided in paragraph (1), notwithstanding the provisions of the preceding paragraph, the investigation concerning the deadline for report must be reported within nine months after the start of the investigation.
(5)A notification of receiving a report prescribed in paragraph (2) to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of the second sentence of Article 14-5, paragraph (2) of the Act is to be given by using a notification based on Form No. 32.
(Application to the PMDA for Confirmation or Investigation of Reexamination)
Article 64(1)When it is determined to have the PMDA conduct the confirmation under Article 14-4, paragraph (3) of the Act or the investigation under paragraph (5) of the same Article (hereinafter referred to as the "confirmation of pharmaceuticals, etc." in this Article and the following Article) pursuant to the provisions of Article 14-2, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 14-5, paragraph (1) of the Act, the applicant for reexamination prescribed in Article 14-4, paragraph (1) of the Act concerning pharmaceuticals provided in Article 29 of the Order must apply to the PMDA for the Confirmation of Pharmaceuticals, etc.
(2)In filing an application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 33 to a written application for reexamination under Article 14-4, paragraph (1) of the Act of the item concerning the application.
(3)The provisions of Article 59, paragraph (4) apply mutatis mutandis to the confirmation of pharmaceuticals, etc. conducted by the PMDA pursuant to the provisions of Article 14-2, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 14-5, paragraph (1) of the Act.In this case, "the Minister of Health, Labour and Welfare ... beyond materials provided in Article 40, paragraph (4) which is applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph" is deemed to be replaced with "the PMDA", "reexamination" with "confirmation under Article 14-4, paragraph (3) of the Act or the investigation under paragraph (5) of the same Article", and "to the Minister of Health, Labour and Welfare" with "to the Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Confirmation of Pharmaceuticals in Reexamination by the PMDA)
Article 65A notification of results of the confirmation of pharmaceuticals, etc. to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 14-2, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 14-5, paragraph (1) of the Act is to be given by using a notification based on Form No. 34.
(Application for Reevaluation of Pharmaceuticals)
Article 66(1)An application for reevaluation of pharmaceuticals prescribed in Article 14-6 of the Act is to be made by submitting a written application based on Form No. 35 (the original copy and two duplicates).
(2)The provisions of Article 40, paragraph (3) apply mutatis mutandis to the data to be submitted for reevaluation of pharmaceuticals prescribed in Article 14-6 of the Act.
(3)The provisions of Article 40, paragraph (4) apply mutatis mutandis to an applicant for reevaluation of pharmaceuticals in Article 14-6 of the Act.In this case, "Minister of Health, Labour and Welfare or a prefectural governor" is deemed to be replaced with "Minister of Health, Labour and Welfare".
(4)Pharmaceuticals specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 14-6, paragraph (4) of the Act are those related to designation by the Minister of Health, Labour and Welfare prescribed in paragraph (1) of the same Article.
(5)The provisions of Article 43 apply mutatis mutandis to the data prescribed in Article 14-6, paragraph (4) of the Act.In this case, "Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 21 of 1997)" in the same Article is deemed to be replaced with "the Ministerial Order on Standards for Post-Marketing Surveillance and Test of Pharmaceuticals (Order of the Ministry of Health and Welfare No. 171 of 2004), the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Pharmaceuticals (Order of the Ministry of Health, Labour and Welfare No. 21 of 1997)" and "the date of disposition whether an approval prescribed in Article 14, paragraph (1) or (9) of the Act is given or not" with "final date of reevaluation prescribed in Article 14-6 of the Act".
(Application to the PMDA for Confirmation or Investigation Concerning Reevaluation)
Article 67(1)When it is determined to have the PMDA conduct the confirmation under Article 14-6, paragraph (2) of the Act or the investigation under paragraph (5) of the same Article (hereinafter referred to as" the confirmation of pharmaceuticals, etc." in this Article and the following Article) pursuant to the provisions of Article 14-2, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 14-7, paragraph (1) of the Act, the applicant for reevaluation prescribed in Article 14-6, paragraph (1) of the Act concerning pharmaceuticals provided in Article 31 of the Order must apply to the PMDA for the Confirmation of Pharmaceuticals, etc.
(2)In filing an application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 36 to a written application for reevaluation under Article 14-6, paragraph (1) of the Act of the item concerning the application.
(Notification of Results of Confirmation of Pharmaceuticals Related to Reevaluation by the PMDA)
Article 68A notification of results of the confirmation of pharmaceuticals, etc. to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 14-2, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 14-7, paragraph (1) of the Act is to be given by using a notification based on Form No. 37.
(Notification of Succession)
Article 69(1)The data and the information specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 14-8, paragraph (1) of the Act is as follows:
(i)data submitted at the time of application for license prescribed in Article 13, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) or accreditation prescribed in Article 13-3, paragraph (1) of the Act;
(ii)data submitted at the time of application for approval prescribed in Article 14, paragraph (1) of the Act and application for approval of partial change to the approved matters prescribed in paragraph (9) of the same Article, and data which the submitted data is based on;
(iii)data submitted at the time of application for reexamination prescribed in Article 14-4, paragraph (1) of the Act, and data which the submitted data is based on;
(iv)data submitted at the time of the report under Article 14-4, paragraph (6) of the Act, and data which the submitted data is based on;
(v)data submitted at the time of application for reevaluation prescribed in Article 14-6, paragraph (1) of the Act, and data which the submitted data is based on;
(vi)records and data related to biological products under Article 68-22, paragraph (1) of the Act;
(vii)the data and the information concerning quality control operations;
(viii)the data and the information concerning post-marketing safety control duties;
(ix)other documents and information concerning quality, efficacy, and safety.
(2)A notification under Article 14-8, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 38 (the original and a duplicate when submitting to the Minister of Health, Labour and Welfare, and the original copy when submitting to a prefectural governor).
(3)A document proving that an applicant succeeds to the status of a person receiving approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics must be attached to the notification prescribed in the preceding paragraph.
(Notification of Marketing)
Article 70(1)A notification under Article 14-9, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 39 (the original and two duplicates when submitting to the Minister of Health, Labour and Welfare while the original and a duplicate when submitting to a prefectural governor).
(2)A notification of changes under Article 14-9, paragraph (2) of the Act is to be made by submitting a written application based on Form No. 40 (the original and two duplicates when submitting to the Minister of Health, Labour and Welfare and the original and a duplicate when submitting to a prefectural governor).
(3)In applying the provisions of paragraphs (1) and (2) in cases of notifying the PMDA pursuant to the provisions of Article 14-10, paragraph (1) of the Act, "the original and two duplicates when submitting to the Minister of Health, Labour and Welfare and the original and a duplicate when submitting to a prefectural governor" in those provisions is deemed to be replaced with "the original and a duplicate when submitting to the PMDA".
(Notice Concerning Acceptance of Notification of Marketing by the PMDA)
Article 71A notice of receiving notification of marketing to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 14-10, paragraph (2) of the Act is to be given by using a notification based on Form No. 41.
Article 72Deleted
Article 73Deleted
Article 74Deleted
Article 75Deleted
Article 76Deleted
Article 77Deleted
Article 78Deleted
Article 79Deleted
Article 80Deleted
Article 81Deleted
Article 82Deleted
Article 83Deleted
Article 84Deleted
(Standards for Marketing Director of the Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 85(1)The standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 17, paragraph (1) of the Act concerning a person responsible for the quality control and post-marketing safety control for quasi-pharmaceutical products stipulate that the person is to fall under any of the following items:
(i)a pharmacist;
(ii)a person who has graduated from a university under the former University Order (Imperial Order No. 388 of 1918), a vocational college based on the former Vocational Colleges Edict (Edict No. 61 of 1903), or completed a course in pharmacology or chemistry at a university or a technical college (hereinafter referred to as a "university, etc.") based on the School Education Act (Act No. 26 of 1947);
(iii)a person who has graduated from a secondary school based on the former Secondary School Order (Imperial Order No. 36 of 1943) (hereinafter referred to as a "former secondary school"), a high school based on the School Education Act (hereinafter referred to as a "high school") or a school equivalent or superior to such a school by completing a course in pharmacology or chemistry and has experience in engaging in the work of quality control or post-marketing safety control for pharmaceuticals or quasi-pharmaceutical products for three years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(2)The standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 17, paragraph (1) of the Act concerning a person responsible for the quality control and post-marketing safety control of cosmetics stipulate that the person is to fall under any of the following items:
(i)a pharmacist;
(ii)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such a school by completing an advanced course in pharmacology or chemistry;
(iii)a person who, after completing subjects concerning pharmacology or chemistry at a former secondary school, a high school, or a school equivalent or greater than the same, and has experience in engaging in the work of quality control or post-marketing safety control for pharmaceuticals, quasi-pharmaceutical products or cosmetics for three years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(Quality Control and Post-Marketing Safety Control for Pharmaceuticals Not Requiring Any Pharmacist)
Article 86A holder of marketing authorization for pharmaceutical may replace a pharmacist with an engineer set forth in each of the following items to be responsible for the quality control and post-marketing safety control of pharmaceuticals set forth in each of those items pursuant to the provisions of the proviso of Article 17, paragraph (1) of the Act:
(i)pharmaceuticals set forth in Article 20, paragraph (1), item (iv) of the Order: a person who falls under either (a) or (b):
(a)a person who has experience in engaging in the work of variety identification of natural diseases in the work of manufacturing or selling natural pharmaceuticals (including work concerning quality control or post-marketing safety control) for five years or more;
(b)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in (a);
(ii)pharmaceuticals set forth in Article 20, paragraph (1), item (vi) of the Order (excluding those for veterinary practices and hereinafter referred to as "medical gasses"): a person who falls under any of (a) through (c) in case of medical gasses:
(a)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such school by completing an advanced course in pharmacology or chemistry;
(b)a person who has experience in engaging in the work of quality control or post-marketing safety control for medical gasses for three years or more after completing subjects concerning pharmacology or chemistry at a former secondary school, a high school, or a school equivalent or greater than the same;
(c)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in (a) or (b).
(Matters to Be Observed for Marketing Director of the Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics)
Article 87Matters to be observed by a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics prescribed in Article 17, paragraph (2) of the Act are as follows:
(i)being knowledgeable about laws and regulations and practices concerning operations related to quality control and post-marketing safety control and fairly and properly undertaking operations;
(ii)expressing necessary opinions with document to a holder of marketing authorization and maintaining a copy for five years if it is recognized that it is necessary to fairly and properly undertake operations;
(iii)closely cooperating with a person responsible for operations concerning the quality control of pharmaceuticals, quasi-pharmaceutical products, or cosmetics (hereinafter referred to as the "quality assurance manager of pharmaceuticals, etc." and a person responsible for operations related to the post-marketing safety control (hereinafter referred to as the "safety control manager of pharmaceuticals, etc.").
(Control of Manufacture of Pharmaceuticals Not Requiring any Pharmacist)
Article 88A holder of license for manufacturing pharmaceutical may replace a pharmacist with an engineer set forth in each of the following items to be responsible for the control and post-marketing safety control of manufacture of pharmaceuticals set forth in each of those items pursuant to the provisions of the proviso of Article 17, paragraph (3) of the Act:
(i)pharmaceuticals set forth in Article 20, paragraph (1), item (iv) of the Order: persons who fall under either (a) or (b):
(a)a person who has experience in engaging in the work of variety identification of natural diseases in the work of manufacturing or selling natural pharmaceuticals (including work concerning quality control or post-marketing safety control) for five years or more;
(b)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in (a);
(ii)medical gasses: persons who fall under any of (a) through (c):
(a)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such school by completing an advanced course in pharmacology or chemistry;
(b)a person who has experience in engaging in the work of manufacturing medical gasses for three years or more after graduating from a former secondary school, a high school, or a school equivalent or greater than the same by mastering subjects concerning pharmacology or chemistry;
(c)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in (a) or (b).
(Respect for Opinions of Managers)
Article 89Manufacturers of pharmaceuticals, quasi-pharmaceutical products, or cosmetics must respect opinions given by a manufacturing supervisor of pharmaceuticals, technical supervisor of quasi-pharmaceutical products, or a person who controls the manufacture of biological products who finds it necessary to satisfy the obligation provided in Article 17, paragraph (4) or (6) of the Act or Article 8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 68-16, paragraph (2).
(Records on Manufacturing and Tests)
Article 90A manufacturing supervisor of pharmaceuticals or a technical supervisor of quasi-pharmaceutical products at manufacturing facilities of pharmaceuticals, quasi-pharmaceutical products, or cosmetics must prepare records concerning manufacturing and tests and other records on control/management at the manufacturing facility, and preserve those records for three years (if it is mandated to enter the validity period or the use period of pharmaceuticals, quasi-pharmaceutical products, or cosmetics related to the records (hereinafter referred to as the "validity period" except in Article 152, paragraph (2)), the records must be preserved for a period with one year added to the validity period); provided, however, that this does not apply where the preparation and the preservation of records are mandated pursuant to other provisions of this Order or those of other pharmaceutical laws and regulations.
(Qualification of Technical Supervisors of Quasi-Pharmaceutical Products)
Article 91(1)Holders of license for manufacturing quasi-pharmaceutical products must assign a technical supervisor who falls under any of the following items pursuant to the provisions of Article 17, paragraph (5) of the Act at every manufacturing facility; provided, however, that a pharmacist must be assigned to a manufacturing facility which manufactures quasi-pharmaceutical products designated by the Minister of Health, Labour and Welfare pursuant to the provisions of Article 20, paragraph (2) of the Order:
(i)a pharmacist;
(ii)a person who has graduated from a university, etc. by completing an advanced course in pharmacology or chemistry;
(iii)a person who has graduated from a former secondary school, a high school, or a school equivalent or greater than the same by mastering subjects concerning pharmacology or chemistry and has experience in engaging in the work of manufacture of pharmaceuticals or quasi-pharmaceutical products for three years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(2)Holders of license for manufacturing cosmetics must assign a technical supervisor who falls under any of the following items pursuant to the provisions of Article 17, paragraph (5) of the Act at every manufacturing facility:
(i)a pharmacist;
(ii)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such a school by completing an advanced course in pharmacology or chemistry;
(iii)a person who has graduated from a former secondary school, a high school, or a school equivalent or greater than the same by mastering subjects concerning pharmacology or chemistry and has experience in engaging in the work of manufacture of pharmaceuticals, quasi-pharmaceutical products or cosmetics for three years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(Matters to Be Observed for Holders of Marketing Authorization for Pharmaceuticals, Quasi-Pharmaceutical Products, and Cosmetics)
Article 92Items to be observed by a holder of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, and cosmetics prescribed in Article 18, paragraph (1) of the Act are as follows:
(i)considerations required for proper marketing according to pharmaceutical laws and regulations are made;
(ii)proper quality control for products to be marketed is provided;
(iii)proper post-marketing safety control for products to be marketed is provided;
(iv)necessary considerations are given so that a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics, a quality assurance manager of pharmaceuticals, etc., and safety control manager of pharmaceuticals, etc. can establish mutual coordination and cooperation among themselves and perform their services;
(v)necessary considerations are given so that a marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics can fulfill the duties pursuant to the provisions of Article 87;
(vi)respect for opinions of a marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics provided in Article 87, item (ii) is given.
Article 92-2A holder of marketing authorization for pharmaceuticals may not sell or provide pharmaceuticals other than pharmaceuticals requiring guidance or OCT pharmaceuticals to a store-based distributor, or pharmaceuticals other than OCT pharmaceuticals to a household distributor.
Article 92-3A pharmacy proprietor who is a holder of marketing authorization for pharmacy-made pharmaceuticals may not sell or provide pharmacy-made pharmaceuticals to a pharmacy proprietor other than the pharmacy, a holder of marketing authorization for pharmaceuticals, or manufacturer or seller of pharmaceuticals.
Article 93Deleted
(Notification Concerning Import of Pharmaceuticals, Quasi-Pharmaceutical Products, or Cosmetics for Marketing)
Article 94(1)A holder of marketing authorization who plans to import pharmaceuticals, quasi-pharmaceutical products, or cosmetics for marketing in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the holder of marketing authorization;
(ii)the type, number, and date of marketing license;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the criteria, accreditation number, and date of accreditation for an accreditation for foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics received by the manufacturing facility prescribed in the preceding item (except for the case of importing cosmetics).
(2)The notification under the preceding paragraph is to be made by submitting a notification based on Form No. 50 (the original and a duplicate).
(3)The holder of marketing authorization must submit a notification based on Form No. 51 (the original and a duplicate) to the Minister of Health, Labour and Welfare if any matter described in a notification prescribed in the preceding paragraph is changed.
(Notification Concerning Import of Pharmaceuticals, Quasi-Pharmaceutical Products, or Cosmetics for Manufacturing)
Article 95(1)A holder of license for manufacturing who plans to import pharmaceuticals, quasi-pharmaceutical products, or cosmetics for manufacture in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the holder of license for manufacturing;
(ii)the criteria, license number, and date of license for a manufacturing license;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the criteria, accreditation number, and date of accreditation for an accreditation for foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics received by the manufacturing facility prescribed in the preceding item (except for the case of importing cosmetics).
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 52 (the original and a duplicate).
(3)The holder of license for manufacturing must submit a notification based on Form No. 52-2 (the original and a duplicate) to the Minister of Health, Labour and Welfare if a matter described in a notification prescribed in the preceding paragraph should be changed.
(Conformity of Methods to Control Manufacturing or Quality to Standards)
Article 96A manufacturer of pharmaceuticals (excluding the following) or quasi-pharmaceutical products (limited to those designated by the Minister of Health, Labour and Welfare as those demanding cautions on manufacturing and quality controls pursuant to the provisions of Article 20, paragraph (2) of the Order) or foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics accredited pursuant to the provisions of Article 13-3, paragraph (1) of the Act (hereinafter referred to as an "accredited foreign manufacturers of pharmaceuticals, quasi-pharmaceutical products or cosmetics") must conform the methods to control manufacturing and quality at the manufacturing facility to the standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 14, paragraph (2), item (iv) of the Act:
(i)pharmaceuticals exclusively used for control or extermination of rats, flies, mosquitoes, fleas, and other animals or insects similar to these (hereinafter referred to as "pharmaceuticals for prevention or extermination"), which are not directly used for human bodies;
(ii)pharmaceuticals exclusively used for disinfection and sterilization (hereinafter referred to as "pharmaceuticals for disinfection and sterilization"), which are not directly used for human bodies;
(iii)pharmaceuticals which are active ingredients for the purpose of provided exclusively for manufacturing pharmaceuticals set forth in the preceding two items;
(iv)pharmaceuticals manufactured at a manufacturing facility where only the process of pulverizing or chipping natural pharmaceuticals is carried out;
(v)pharmacy-made pharmaceuticals;
(vi)gasses provided for medical purposes designated by the Minister of Health, Labour and Welfare;
(vii)beyond what is set forth in each of the preceding items, pharmaceuticals listed in the Japanese Pharmacopoeia which are designated by the Minister of Health, Labour and Welfare as those that relieve influence on the human body.
(Matters to Be Observed by Manufacturers of Pharmacy-Made Pharmaceuticals)
Article 96-2(1)A pharmacy proprietor who is a holder of license for manufacturing pharmacy-made pharmaceuticals must have pharmacists engaged in dispensing of medicine at the pharmacy dispense pharmacy-made pharmaceuticals with equipment and instruments at the pharmacy.
(2)A pharmacy proprietor who is a holder of license for manufacturing pharmacy-made pharmaceuticals may not sell or provide pharmacy-made pharmaceuticals to a holder of marketing authorization for pharmaceuticals or manufacturer of pharmaceuticals other than the pharmacy.
(Scope for Entrusting Post-Marketing Safety Control)
Article 97Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 18, paragraph (3) of the Act are as follows:
(i)collection of information on matters concerning the quality, efficacy, and safety of pharmaceuticals, quasi-pharmaceutical products, or cosmetics and other information required for the appropriate use of pharmaceuticals, quasi-pharmaceutical products, or cosmetics (hereinafter referred to as "safety control information" in this chapter);
(ii)analysis of the safety control information;
(iii)implementation of necessary measures based on results of the investigation of the safety control information;
(iv)maintaining collected safety control information and business operations incidental to those set forth in the preceding three items.
(Scope for Further Entrusting Post Marketing Safety Control Activities)
Article 98(1)A holder of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics may not let a person to whom activities concerning the post-marketing safety control (hereinafter referred to as the "post-marketing safety control activities ") are entrusted (hereinafter referred to as a "trustee" in this chapter) further entrust the post-marketing safety control activities.
(2)Notwithstanding the provisions of the preceding paragraph, in entrusting the post-marketing safety control activities concerning pharmaceuticals approved to be marketed integrally with medical appliances or instruments, etc. to a holder of marketing authorization for medical devices who supplies the medical appliances or instruments, etc., the holder of marketing authorization for pharmaceuticals may have the trustee further entrust the post-marketing safety control activities.
(3)Notwithstanding the provisions of paragraph (1), when selling or providing pharmaceuticals to another holder of marketing authorization for pharmaceuticals, and entrusting the post-marketing safety control activities concerning the pharmaceuticals to the relevant other holder of marketing authorization, the holder of marketing authorization for pharmaceuticals may have the trustee further entrust the post-marketing safety control activities that are set forth in items (i) to (iii) of the preceding Article.
(4)A holder of marketing authorization for pharmaceuticals may not let a person to whom the post-marketing safety control activities are further entrusted pursuant to the provisions of the preceding two paragraphs additionally entrust the post-marketing safety control activities.
(Measures to Entrust Post-Marketing Safety Control Activities for Prescription Pharmaceuticals)
Article 98-2(1)When a holder of marketing authorization entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals (excluding in-vitro diagnostics; hereinafter the same applies in this chapter), the trustee must meet the following requirements:
(i)a person is capable of conducting entrusted activities (hereinafter referred to as "entrusted safety assurance activities" in this article) appropriately and smoothly;
(ii)a supervisor conducting the activities who is capable of implementing the entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "entrusted safety control implementation supervisor" in this Article and Article 98-6) is assigned;
(iii)a copy of the procedure manuals concerning entrusted safety assurance activities prescribed in the following paragraph and other documents required for the entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities") is provided at an office which implements the entrusted safety assurance activities.
(2)In entrusting activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization must prepare operating procedures for the post-marketing safety control activities concerning entrusted safety assurance activities to state the following procedures:
(i)the procedure for collecting the safety control information;
(ii)the procedure for planning safety assurance measures based on the review of the safety control information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the entrusted safety control implementation supervisor to the safety control manager of pharmaceuticals, etc.;
(v)the procedure concerning the pharmaceutical risk management provided in Article 2, paragraph (3) of the Ministerial Order on Standards for Post-Marketing Safety Control of Pharmaceuticals, Quasi-Pharmaceutical Products, Cosmetics, Medical Devices, and Regenerative Medicine Products (referred to as the "pharmaceutical risk management" in Article 98-6, paragraph (2), item (v)) (including procedures concerning EPPV);
(vi)the procedure for entrustment;
(vii)the procedure for maintain records concerning entrusted safety assurance activities;
(viii)the procedure for mutual cooperation with a quality assurance manager of pharmaceuticals, etc. and a person responsible for operations concerning marketing other prescription pharmaceuticals;
(ix)the procedure required to appropriately and smoothly implement other entrusted safety assurance activities.
(3)In entrusting activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization must conclude an agreement with a trustee with a document listing the following matters and maintain the agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of entrusted safety assurance activities;
(ii)matters concerning an assignment of the entrusted safety control implementation supervisor and the scope of entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph concerning the entrusted safety assurance activities (excluding item (vi));
(iv)matters related to instructions for implementation of entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction prescribed in paragraph (7) and the confirmation prescribed in paragraph (8);
(vii)matters related to the provision of information prescribed in paragraph (9);
(viii)other necessary matters.
(4)In entrusting activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization must have a safety control manager of pharmaceuticals, etc. conduct the following business operations based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph:
(i)supervising entrusted safety assurance activities;
(ii)instructing the entrusted safety control implementation supervisor in the implementation of entrusted safety assurance activities with document and maintaining copies of the document (excluding the case where activities set forth in Article 97, item (i) are entrusted);
(iii)having the entrusted safety control implementation supervisor prepare records concerning entrusted safety assurance activities and report them with document;
(iv)confirming whether a trustee implements entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to a holder of marketing authorization and a marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics with document.
(5)When entrusting activities related to EPPV and set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization must have a safety control manager of pharmaceuticals, etc. implement the following activities based on the operating procedures, etc. for post-marketing safety control activities and the early post-marketing phase vigilance plan provided in Article 10, paragraph (1) of the Ministerial Order on Standards for Post-Marketing Safety Control of Pharmaceuticals, Quasi-Pharmaceutical Products, Cosmetics, Medical Devices, and Regenerative Medicine Products (including as applied mutatis mutandis pursuant to Article 14 of the same Ministerial Order) (hereinafter referred to as the "EPPV plan"):
(i)having the entrusted safety control implementation supervisor prepare records concerning entrusted safety assurance activities and report them with document;
(ii)maintaining the documents in the preceding item.
(6)When entrusting activities set forth in Article 97, item (iv) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization must entrust them to a person who is able to implement the entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization must conclude an agreement with the trustee with a document listing the following matters and maintain the written agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of entrusted safety assurance activities;
(ii)other necessary matters.
(7)A holder of marketing authorization must have a safety control manager of pharmaceuticals, etc. review the necessity for improvement of entrusted safety assurance activities, and if it is necessary, instruct the trustee to take required measures with document and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(8)In giving an instruction based on the provisions of the preceding paragraph, a holder of marketing authorization must confirm if the measures were implemented and maintain the record.
(9)A holder of marketing authorization must provide a trustee with information necessary to implement entrusted safety assurance activities.
(Measures to Entrust Post-Marketing Safety Control Activities for Pharmaceuticals Other Than Prescription Pharmaceuticals)
Article 98-3When a holder of marketing authorization entrusts activities set forth in each of the items in Article 97 from among the post-marketing safety control activities of pharmaceuticals other than prescription pharmaceuticals, the provisions of the preceding Article (excluding paragraph (1), item (ii), paragraph (2), item (iv), and paragraph (3), item (ii)) apply mutatis mutandis.In this case, the "entrusted safety control implementation supervisor" in paragraph (4), items (ii) and (iii) and paragraph (5) of the same Article is deemed to be replaced with a "preliminarily designated person".
(Measures to Entrust Post-Marketing Safety Control Activities for Quasi-Pharmaceutical Products and Cosmetics)
Article 98-4When a holder of marketing authorization entrusts activities set forth in each of the items in Article 97 from among the post-marketing safety control activities of quasi-pharmaceutical products or cosmetics, the provisions of Article 98-2, paragraph (1), item (i) and paragraphs (3) through (9) of the same Article (excluding paragraph (3), items (ii) and (iii), and paragraph (5)) apply mutatis mutandis.In this case, "following ... based on operating procedures, etc. for post-marketing safety control activities" in paragraph (3) of the same Article is deemed to be replaced with "following", "the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph" in paragraph (4) of the same Article with "the preceding paragraph", "the entrusted safety control implementation supervisor" in items (ii) and (iii) of the same paragraph with "preliminarily designated person", "following ...operating procedures, etc. for post-marketing safety control activities" in paragraph (6) of the same Article with "following", and "the operating procedures, etc. for post-marketing safety control activities and ... paragraph (3)" in paragraph (7) of the same Article with "paragraph (3)".
(Maintaining Records Concerning Entrusted Safety Assurance Activities)
Article 98-5(1)The period for maintaining documents to be maintained pursuant to the provisions of the preceding three Articles and other records is five years from the day when the record is no longer used; provided, however, that periods for maintaining the following records are the periods specified in each item:
(i)records concerning biological products (excluding those set forth in the following item):10 years from the day when they are no longer used;
(ii)records concerning specified biological products:30 years from the day when they were no longer used.
(2)Notwithstanding the provisions of the preceding three Articles, a holder of marketing authorization may replace a person who must maintain records pursuant to the provisions of the preceding three Articles based on the operating procedures, etc. for the post-marketing safety control activities or predetermined documents with a person designated by a holder of marketing authorization, and have the person maintain the records.
(Measures to Further Entrust Post-Marketing Safety Control Activities for Prescription Pharmaceuticals)
Article 98-6(1)When a trustee further entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, the further trustee of the activities must meet the following requirements:
(i)a person is capable of appropriately and smoothly conducting further-entrusted activities (hereinafter referred to as "further-entrusted safety assurance activities" in this Article);
(ii)a supervisor conducting the activities who is capable of implementing the further-entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "further-entrusted safety control implementation supervisor" in this Article) is assigned;
(iii)a copy of the procedure manuals prescribed in the following paragraph concerning further-entrusted safety assurance activities and other documents required for the further-entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities" in this Article) is provided at an office which implements the further-entrusted safety assurance activities.
(2)When a trustee further entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization who is the entruster must have the trustee prepare the operating procedures for post-marketing safety control activities concerning further-entrusted safety assurance activities that state the following procedures:
(i)the procedure for collecting the safety control information;
(ii)the procedure for planning safety assurance measures based on the review of the safety control information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the further-entrusted safety control implementation supervisor to the entrusted safety control implementation supervisor;
(v)the procedure for pharmaceutical risk management (including procedures concerning EPPV);
(vi)the procedure for further entrustment;
(vii)the procedure for maintaining records concerning further-entrusted safety assurance activities;
(viii)the procedure for the trustee's mutual cooperation with a quality assurance manager of pharmaceuticals, etc. or a domestic quality assurance administrator, and other persons responsible for operations concerning marketing prescription pharmaceuticals;
(ix)the procedure required to appropriately and smoothly implement other further-entrusted safety assurance activities.
(3)When a trustee further entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with a further trustee with a document listing the following matters and maintain the written agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)matters concerning assignment of the further-entrusted safety control implementation supervisor and the scope of further-entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph (excluding item (vi)) concerning further-entrusted safety assurance activities;
(iv)matters related to instructions for implementation of further-entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction prescribed in paragraph (7) and the confirmation prescribed in paragraph (8);
(vii)matters related to the provision of information prescribed in paragraph (9);
(viii)other necessary matters.
(4)When a trustee further entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization who is the entruster must confirm that the trustee has the entrusted safety control implementation supervisor implement the following activities based on operating procedures, etc. for post-marketing safety control and the agreement prescribed in the preceding paragraph:
(i)supervising further-entrusted safety assurance activities;
(ii)instructing the further-entrusted safety control implementation supervisor in the implementation of further-entrusted safety assurance activities with document and maintaining copies of the document (excluding the case where activities set forth in Article 97, item (i) are entrusted);
(iii)having the further-entrusted safety control implementation supervisor prepare records concerning further-entrusted safety assurance activities and report them with document;
(iv)confirming whether a further trustee implements further-entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to a trustee, and the trustee's marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics or a marketing director of medical devices, etc. with document.
(5)When a trustee further entrusts activities related to EPPV and set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization who is the entruster must confirm that the trustee has the entrusted safety control implementation supervisor implement the following activities based on operating procedures, etc. for post-marketing safety control activities and the EPPV plan:
(i)having the further-entrusted safety control implementation supervisor prepare records concerning further-entrusted safety assurance activities and report them with document;
(ii)maintaining documents in the preceding item.
(6)When a trustee further entrusts activities set forth in Article 97, item (iv) from among the post-marketing safety control activities of prescription pharmaceuticals, a holder of marketing authorization who is the entruster must have the trustee further entrust them to a person who is able to implement the further-entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with the further trustee with a document listing the following matters and maintain the written agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)other necessary matters.
(7)A holder of marketing authorization who is the entruster must have the trustee instruct the entrusted safety control manager of pharmaceuticals, etc. to review the necessity of improvement of further-entrusted safety assurance activities, and if it is necessary, instruct the further trustee to take required measures with document, and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(8)When a trustee gives an instruction based on the provisions of the preceding paragraph, a holder of marketing authorization who is the entruster must have the trustee confirm if the measures were implemented and maintain the record.
(9)A trustee must provide information necessary to implement further-entrusted safety assurance activities to a further-trustee.
(10)When a trustee further entrusts activities set forth in Article 97, items (i) through (iii) from among the post-marketing safety control activities pursuant to the provisions of Article 98, paragraph (3), a holder of marketing authorization who is the entruster is to ensure a system to directly confirm a further trustee as required.
(Measures to Further Entrust Post-Marketing Safety Control Activities for Pharmaceuticals Other Than Prescription Pharmaceuticals)
Article 98-7When a trustee further entrusts activities set forth in each of the items in Article 97 from among the post-marketing safety control activities of pharmaceuticals other than prescription pharmaceuticals, the provisions of the preceding Article (excluding paragraph (1), item (ii), paragraph (2), item (iv), and paragraph (3), item (ii)) apply mutatis mutandis.In this case, "entrusted safety control implementation supervisor" in paragraph (4) of the same Article is deemed to be replaced with "person preliminary designated by a trustee", "further-entrusted safety control implementation supervisor" in items (ii) and (iii) of the same paragraph with "person preliminary designated by a further trustee", "entrusted safety control implementation supervisor" in paragraph (5) of the same Article with "person preliminary designated by a trustee", "further-entrusted safety control implementation supervisor" in item (i) of the same paragraph with "person preliminary designated by a further trustee", and "entrusted safety control implementation supervisor" in paragraph (7) of the same Article with "person preliminary designated by a trustee".
(Maintaining Records Concerning Further-Entrusted Safety Assurance Activities)
Article 98-8The provisions of Article 98-5 apply mutatis mutandis to the period for maintaining documents and other records to be maintained pursuant to the provisions of the preceding two Articles.In this case, "holder of marketing authorization" in paragraph (2) of the same Article is deemed to be replaced with "trustee" and "preceding three Articles" with "Article 98-6 and Article 98-7".
(Notification of Changes of Marketing Director of the Pharmaceuticals, Quasi-Pharmaceutical Products or Cosmetics in Marketing)
Article 99(1)Matters whose changes must be notified pursuant to the provisions of Article 19, paragraph (1) of the Act are as follows:
(i)the name and address of the holder of marketing authorization;
(ii)the name and location of the office with major functions;
(iii)if the holder of marketing authorization is a corporation, the name of the officer who is engaged in the operation;
(iv)the name and address of the marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics;
(v)if the holder of marketing authorization receives another type of license for marketing or abolishes the business concerning the license, the type of the license and the license number.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 6.
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the notifications at the time of application and other acts, if the notification has a supplementary note to that effect:
(i)a notification concerning names of holders of marketing authorization set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of a holder of marketing authorization (a certificate of registered information if the holder of marketing authorization is a corporation);
(ii)a notification concerning an officer set forth in paragraph (1), item (iii):a doctor's written diagnosis with regard to mental impairment of the new officer or whether or not the officer is addicted to narcotics, cannabis, opium, or stimulants;
(iii)a notification concerning matters set forth in paragraph (1), item (iv) (excluding a case where a new marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics is a holder of marketing authorization):a copy of an employment agreement or other documents proving an employment relationship between a holder of marketing authorization and a new marketing director of pharmaceuticals, quasi-pharmaceutical products or cosmetics.
(4)The provisions of Article 16, paragraph (4) apply mutatis mutandis to a notification prescribed in paragraph (1). In this case, "the" in the same paragraph is deemed to be replaced with "in case of a pharmacy which markets pharmacy-made pharmaceuticals, the".
(Notification of Changes of Manufacturing Supervisors of Pharmaceuticals of Manufacturing)
Article 100(1)Matters whose changes must be notified pursuant to the provisions of Article 19, paragraph (2) of the Act are as follows:
(i)the name or address of a holder of license for manufacturing or a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics (hereinafter referred to as a "manufacturer, etc." in this Article), or in the case of a manufacturing supervisor of pharmaceuticals or a technical supervisor of quasi-pharmaceutical products (a person in charge of the manufacturing facility in the case of a foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics) (referred to as a "manufacturing supervisor of pharmaceuticals, etc.");
(ii)if the manufacturer, etc. is a corporation, the name of the officer who is engaged in the operation;
(iii)the name of the manufacturing facility;
(iv)the main parts of structure and equipment for the manufacturing facility;
(v)if the manufacturer, etc. receives another license, accreditation, or registration for manufacturing, or abolishes the manufacturing facility, the criteria and license number for the license, the criteria and accreditation number for the accreditation, or the registration number for the registration.
(2)A notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 6 (the original and two duplicates when submitting to the Director of the Regional Bureau of Health and Welfare and the original and a duplicate when submitting to the Minister of Health, Labour and Welfare or a prefectural governor).
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare, the Director of the Regional Bureau of Health and Welfare or a prefectural governor who is in charge of receiving the notifications at the time of the application and other acts, or submitted to the Minister of Health, Labour and Welfare or the Director of the Regional Bureau of Health and Welfare via the prefectural governor, if the notification has a supplementary note to that effect:
(i)a notification concerning names of manufacturer, etc. set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of the manufacturer etc. (certificate of registered information if the manufacturer etc. is a corporation);
(ii)a notification concerning names of manufacturing supervisors of pharmaceuticals, etc. set forth in paragraph (1), item (i) (excluding the case where a manufacturing supervisor of pharmaceuticals, etc. is a manufacturer, etc.):a copy of an employment agreement or other documents proving an employment relationship between a manufacturer, etc. and a manufacturing supervisor of pharmaceuticals;
(iii)a notification concerning an officer set forth in paragraph (1), item (ii):a document which shows a new officer does not fall under Article 5, item (iii), (e) and (f) of the Act.
(Maintaining Data)
Article 101A person receiving approval for pharmaceuticals, quasi-pharmaceutical products or cosmetics must preserve data set forth in each of the following items for periods set forth in each of the same items; provided, however, that this does not apply to data in case where it is recognized that the nature of the data makes it extremely difficult to preserve it:
(i)data which the data submitted at the time of application for approval prescribed in Article 14, paragraph (1) of the Act or paragraph (9) of the same Article is based on:five years from the date when the approval is obtained; provided, however, that for data concerning pharmaceuticals that must be reexamined pursuant to the provisions of Article 14-4, paragraph (1) of the Act (limited to those whose period from the day when an approval is obtained to the day when a reexamination is completed is more than five years), the period until the reexamination is completed;
(ii)data which the data submitted at the time of application for reexamination prescribed in Article 14-4, paragraph (1) of the Act (excluding data set forth in the preceding item) is based on:five years from the date when the reexamination is completed;
(iii)data which the data submitted at the time of application for reevaluation on pharmaceuticals prescribed in Article 14-6 of the Act (excluding data set forth in the preceding two items) is based on:five years from the date when the reevaluation is completed.
(Application for Marketing Approval of Pharmaceuticals Manufactured in Foreign Countries)
Article 102(1)An application for marketing approval of pharmaceuticals, quasi-pharmaceutical products, or cosmetics prescribed in Article 19-2, paragraph (1) of the Act is to be carried out by submitting a written application based on Form No. 53 (the original and two duplicates) to the Minister of Health, Labour and Welfare.
(2)The provisions of Articles 40 and 41 apply mutatis mutandis to the data that should be attached to a written application prescribed in the preceding paragraph.In this case, "Minister of Health, Labour and Welfare or a prefectural governor" in these provisions is deemed to be replaced with "Minister of Health, Labour and Welfare".
(3)The following documents must be attached to the written application prescribed in paragraph (1); provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate proving the same;
(ii)documents clearly indicating whether an applicant (including officers engaged in the business operation if the applicant is a corporation) is one provided in Article 19-2, paragraph (2) of the Act;
(iii)documents proving that a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. has been designated;
(iv)a copy of license certificate for marketing obtained by the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.;
(v)documents proving that items to be marketed by an applicant are pharmaceuticals set forth in Article 14-3, paragraph (1), item (ii) of the Act in applying for an approval prescribed in Article 19-2, paragraph (1) of the Act pursuant to the provisions of Article 14-3, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 20 of the Act and other necessary documents.
(Matters to Be Included in Registry of Approval for Marketing Pharmaceuticals Manufactured in Foreign Countries)
Article 103Matters to be included in the registry of approval prescribed in Article 14, paragraph (9) of the Act as applied mutatis mutandis pursuant to Article 19-2, paragraphs (1) and (5) of the Act provided in Article 19 of the Order are, beyond those set forth in each of the items in Article 49 (excluding item (iii)), the following matters:
(i)the name and address of a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.;
(ii)the type and license number for the marketing license obtained by the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.
(Matters to Be Observed by Designated Holders of Marketing Authorization for Foreign-Manufactured Pharmaceuticals, etc.)
Article 104Matters to be observed by a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. are as follows beyond what is set forth in each of the items of Article 92:
(i)matters related to activities as a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. are recorded and maintained for five years from the date on which the final description therein was made;
(ii)documents set forth in the following (a) to (e) are maintained for five years from the date when they were no longer used:
(a)documents listing matters for which a person with special approval for foreign-manufactured pharmaceuticals, etc. has obtained the approval;
(b)copies of data submitted by a person with special approval for foreign-manufactured pharmaceuticals, etc. at the time of application for approval prescribed in Article 19-2, paragraph (1) of the Act, and Article 14, paragraph (9) of the Act as mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act;
(c)copies of data submitted by a person with special approval for foreign-manufactured pharmaceuticals, etc. at the time of application for reexamination prescribed in Article 14-4, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act;
(d)copies of data submitted by a person with special approval for foreign-manufactured pharmaceuticals, etc. at the time of application for reevaluation prescribed in Article 14-6, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act;
(e)matters reported by a person with special approval for foreign-manufactured pharmaceuticals, etc. to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 14-4, paragraph (6) or Article 14-5, paragraph (2) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act, periodic reporting of infectious diseases related to biological products reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 68-24, paragraph (1) or Article 68-25, paragraph (3) of the Act, and documents showing matters reported to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 75-2-2, paragraph (1), item (ii) of the Act;
(iii)the data on which matters related to side effects reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 68-10, paragraph (1) of the Act or Article 68-13, paragraph (3) of the Act are based is preserved for five years from the day when they were no longer used; provided, however, that this does not apply to data in the case where it is recognized that the nature of the data makes it extremely difficult to preserve.
(Notification of Changes Concerning Designated Holders of Marketing Authorization for Foreign-Manufactured Pharmaceuticals, etc.)
Article 105(1)Matters for which changes must be notified pursuant to the provisions of Article 19-3 of the Act are as follows:
(i)the name or address of a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.;
(ii)the type and license number for the marketing license obtained by a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.
(2)A notification of changes of a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. under Article 19-3 of the Act and the notification prescribed in the preceding paragraph are to be made by submitting a notification per item (the original and two duplicates) based on Form No. 54.
(3)A copy of license certificate for marketing obtained by the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. must be attached to the notification prescribed in the preceding paragraph; provided, however, that this does not apply to cases where a copy of the license certificate is submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the notification has a supplementary note to that effect.
(Provision of Information)
Article 106(1)A person with special approval for foreign-manufactured pharmaceuticals, etc. must provide the following information to a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.:
(i)changed matters and reasons for the changes if matters are approved concerning the item pursuant to the provisions of Article 19-2, paragraph (1) of the Act and any change is made on the approved matters pursuant to the provisions of Article 14, paragraph (9) of the Act as applied mutatis mutandis pursuant to paragraph (5) of the same Article;
(ii)copies of data submitted at the time of application for approval prescribed in Article 19-2, paragraph (1) of the Act, and Article 14, paragraph (9) of the Act as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act, copies of data submitted at the time of application for reexamination prescribed in Article 14-4, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act, and copies of data submitted at the time of application for reevaluation prescribed in Article 14-6, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act;
(iii)matters reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to provisions of Article 14-4, paragraph (6) or Article 14-5, paragraph (2) of the Act as applied mutatis mutandis pursuant to Article 19-4 of the Act;
(iv)information required to describe matters provided in Articles 50, 59, 61, or 68-17 of the Act or if the information has been changed, a reason for the change;
(v)information concerning matters provided in Article 52 of the Act (including as applied mutatis mutandis pursuant to Article 60 or 62 of the Act) or Articles 68-18 of the Act and reasons for the change if any;
(vi)matters reported to the Minister of Health, Labour and Welfare pursuant to provisions of Article 69, paragraph (1) or (4) or Article 75-2-2, paragraph (1), item (ii) of the Act;
(vii)beyond what is set forth in each of the preceding items, information necessary for designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc.
(2)In changing a designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc., a person with special approval for foreign-manufactured pharmaceuticals, etc. must have the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. before change carry over records provided in Article 104, item (i), documents provided in item (ii) of the same Article, documents provided in item (iii) of the same Article, and information provided in the preceding paragraph, data concerning quality control operations, and data concerning post-marketing safety control activities to the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. after the change.
(3)In cases prescribed in the preceding paragraph, if the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. before change is a person approved for biological products provided in Article 68-22, paragraph (1) of the Act, the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. must deliver records concerning biological products and data relating to the records to the designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc. after the change.
(Books Concerning Activities of Persons with Special Approval for Foreign-Manufactured Pharmaceuticals, etc.)
Article 107A person with special approval for foreign-manufactured pharmaceuticals, etc. must prepare books, provide information to designated holder of marketing authorization for foreign-manufactured pharmaceuticals, etc., and record matters concerning other activities as a person with special approval for foreign-manufactured pharmaceuticals, etc. and maintain the book for three years from the date on which the final description therein was made.
(Notification of Changes Concerning Persons with Special Approval for Foreign-Manufactured Pharmaceuticals, etc.)
Article 108(1)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 34, paragraph (1) of the Order are as follows:
(i)the name or address of a person with special approval for foreign-manufactured pharmaceuticals, etc.;
(ii)if a person with special approval for foreign-manufactured pharmaceuticals, etc. is a corporation, the name of the officer who is engaged in the activities;
(iii)a manufacturing facility which manufactures approved items or its name.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 54 (the original and two duplicates).
(3)If a notification prescribed in paragraph (1) is concerning matters set forth in item (i) of the same paragraph, documents proving this, and if it is concerning matters set forth in item (ii) of the same paragraph, documents clearly indicating whether an officer after the change is a person provided in Article 19-2, paragraph (2) of the Act or not must be attached to the notification in the preceding paragraph.
(Procedures for Application of Persons with Special Approval for Foreign-Manufactured Pharmaceuticals, etc.)
Article 109Procedures for application, notification, report, submission, and others from a person who intends to receive an approval prescribed in Article 19-2, paragraph (1) of the Act or a person with special approval for foreign-manufactured pharmaceuticals, etc. to the Minister of Health, Labour and Welfare are to be carried out by a designated holder of marketing authorization for foreign manufactured pharmaceuticals, etc.
(Maintaining Data of Persons with Special Approval for Foreign-Manufactured Pharmaceuticals, etc.)
Article 110(1)The provisions of Article 101 apply mutatis mutandis to a person with special approval for foreign-manufactured pharmaceuticals, etc..
(2)A person with special approval for foreign-manufactured pharmaceuticals, etc. must maintain data on which matters reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 75-2-2, paragraph (1), item (ii) of the Act are based for five years from the day when they are reported to the minister.
(3)When maintaining the data prescribed in the preceding paragraph, the provisions of the proviso of the parts other than those listed in each of the items in Article 101 apply mutatis mutandis.
(Application, Mutatis Mutandis)
Article 111The provisions of Article 39, Articles 41 through 48, Article 50, and Articles 54 through 69 apply mutatis mutandis to an approval prescribed in Article 19-2, paragraph (1) of the Act or Article 14, paragraph (9) of the Act as applied mutatis mutandis pursuant to Article 19-2, paragraph (5) of the Act.In this case, "Form No. 23" in Article 46 is deemed to be replaced with "Form No. 55", "Form No. 24" in Article 48, paragraph (1) with "Form No. 56", "Form No. 25" in Article 50, paragraph (1) with "Form No. 57", "Form No. 27" in Article 54, paragraph (3) with "Form No. 58", "Form No. 30" in Article 56 with "Form No. 59", "Form No. 33" in Article 64, paragraph (2) with "Form No. 60", "Form No. 35" in Article 66, paragraph (1) with "Form No. 61", "Form No. 36" in Article 67, paragraph (2) with "Form No. 62", and "Form No. 38" in Article 69, paragraph (2) with "Form No. 63".
Article 111-2The provisions of Article 15-9 apply mutatis mutandis to holders of marketing authorization for pharmaceuticals or manufacturers of pharmaceuticals, quasi-pharmaceutical products, or cosmetics.In this case, "as a registered sales clerk" in paragraph (1) of the same Article is deemed to be replaced with "prescribed by Article 85, paragraph (1), item (iii) or paragraph (2), item (iii); Article 86, item (i), (a) or item (ii), (b); Article 88 item (i), (a) or item (ii), (b); or Article 91, paragraph (1), item (iii) or paragraph (2), item (iii)".
Article 112The provisions of Article 14, paragraphs (1) and (3) apply mutatis mutandis to holders of marketing authorization for pharmaceuticals or manufacturers of pharmaceuticals.In this case, "for three years... for two years since the day on which the final description is made in documents in the preceding paragraph" in paragraph (3) of the same Article is deemed to be replaced with "three years".
Article 113The provisions of Article 15-10 apply mutatis mutandis to holders of marketing authorization for or manufacturers of pharmaceuticals, quasi-pharmaceutical products, or cosmetics.In this case, "a pharmacist or a registered sales clerk" is deemed to be replaced with a "pharmacist".
Article 114(1)The provisions of Articles 3 and 18 apply mutatis mutandis to holders of marketing authorization for pharmaceuticals, quasi-pharmaceutical products, or cosmetics (excluding those for pharmacy-made pharmaceuticals).
(2)The provisions of Articles 3 and 18 apply mutatis mutandis to holder of license for manufacturing pharmaceuticals, quasi-pharmaceutical products, or cosmetics (excluding those of pharmacy-made pharmaceuticals). In this case, "notifications" in Article 18 is deemed to be replaced with "notifications (the original and two duplicates when submitting to the Minister of Health, Labour and Welfare and the original and a duplicate when submitting to a prefectural governor.)"
(3)The provisions of Articles 3 and 18 apply mutatis mutandis to holders of marketing authorization for or manufacturers of pharmacy-made pharmaceuticals.
(4)The provisions of Article 18 apply mutatis mutandis to an accredited foreign manufacturer of pharmaceuticals, quasi-pharmaceutical products or cosmetics.
Chapter III Marketing and Manufacturing Medical Devices and In-Vitro Diagnostics
Section 1 Marketing and Manufacturing Medical Devices and In-Vitro Diagnostics
(Application for License for Marketing Medical Devices and In-Vitro Diagnostics)
Article 114-2(1)An application for license for marketing medical devices and in-vitro diagnostics prescribed in Article 23-2, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 9 to a prefectural governor who is responsible for activities related to the authority pursuant to the provisions of Article 80 of the Order.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the written applications at the time of application and other acts, or submitted to the Minister of Health, Labour and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)a doctor's written diagnosis with regard to mental impairment of an applicant (if the applicant is a corporation, the officer responsible for the operation; the same applies hereinafter in this item) or whether or not the applicant is addicted to narcotics, cannabis, opium, or stimulants;
(iii)if an applicant actually receives a license for marketing, a copy of the license certificate for marketing;
(iv)if an applicant is a corporation, an organization chart;
(v)if a person other than an applicant is a marketing director of medical devices, etc., a copy of an employment agreement and other documents proving an employment relationship between the applicant and the marketing director of the medical devices, etc.;
(vi)documents proving that the marketing director of medical devices, etc. is the person provided in Article 23-2-14, paragraph (1) of the Act;
(vii)documents concerning the system for manufacturing or quality control;
(viii)documents concerning the system concerning post-marketing safety control.
(3)The applicant may submit a document proving the officer does not fall under Article 5, item (iii), (e) and (f) of the Act in place of a written diagnosis set forth in item (ii) of the preceding paragraph if an applicant is a corporation and a prefectural governor who is responsible for activities concerning providing the license pursuant to the provisions of Article 80 of the Order, acknowledges, judging from duties of the officer, that business operation is not adversely affected.
(4)The provisions of Article 9 apply mutatis mutandis to an application prescribed in paragraph (1).In this case, "a prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward)" in the same Article is deemed to be replaced with "a prefectural governor".
(Form of License Certificate for Marketing)
Article 114-3The license certificate for marketing medical devices or in-vitro diagnostics is to be based on Form No. 10.
(Application for Updated Issuance of License Certificate for Marketing)
Article 114-4A written application prescribed in Article 37-2, paragraph (2) of the Order is to be based on Form No. 3.
(Application for Reissuance of License Certificate for Marketing)
Article 114-5A written application prescribed in Article 37-3, paragraph (2) of the Order is to be based on Form No. 4.
(Application for Renewal of License for Marketing)
Article 114-6(1)An application for a renewal of license for marketing medical devices or in-vitro diagnostics prescribed in Article 23-2, paragraph (2) of the Act is to be made by submitting a written application based on Form No. 11 to a prefectural governor who is responsible for activities related to the authority pursuant to the provisions of Article 80 of the Order.
(2)The license certificate of a license pertaining to the application must be submitted together with the written application prescribed in the preceding paragraph.
(Matters to Be Included in the Registry of License for Marketing)
Article 114-7Matters to be included the registry of license prescribed in Article 23-2, paragraph (1) of the Act provided in Article 37-5, paragraph (1) of the Order are as follows:
(i)the license number and date;
(ii)the type of license;
(iii)the name and address of the holder of marketing authorization;
(iv)the name and location of the office where the marketing director of medical devices, etc. performs the activities (hereinafter referred to as the "office with major functions" in this chapter);
(v)the name and address of the marketing director of medical devices;
(vi)in case where the holder of marketing authorization receives another type of license for marketing, the type of the license and the license number.
(Manufacturing Process at Manufacturing Facilities Obtaining Registration of Manufacturing)
Article 114-8The manufacturing process specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-3, paragraph (1) of the Act is to be set forth in each item in accordance with the type of medical devices or in-vitro diagnostics set forth in the following items:
(i)medical devices programs:design;
(ii)medical devices which are recording media recording medical device programs: the following manufacturing processes:
(a)design;
(b)domestic storage of final products;
(iii)general medical devices: the following manufacturing processes:
(a)main assembly and other main manufacturing processes (excluding design, sterilization, and storage. The same applies in (b) of the following item);
(b)sterilization;
(c)domestic storage of final products;
(iv)medical devices other than medical devices set forth in the preceding three items: the following manufacturing processes:
(a)design;
(b)main assembly and other main manufacturing processes;
(c)sterilization;
(d)domestic storage of final products;
(v)in-vitro diagnostics, which are radioactive pharmaceuticals (hereinafter referred to as "radioactive in-vitro diagnostics"): the following manufacturing processes:
(a)design;
(b)all manufacturing processes after the filling of components concerning reaction system into final products;
(vi)in-vitro diagnostics provided in Article 23-2-5, paragraph (1) of the Act and Article 23-2-23, paragraph (1) of the Act (excluding those set forth in the preceding item): the following manufacturing process:
(a)design;
(b)the process of filling of components concerning reaction system into final products;
(c)domestic storage of final products;
(vii)in-vitro diagnostics other than in-vitro diagnostics set forth in preceding two items: the following manufacturing processes:
(a)the process of filling of components concerning reaction system into final products;
(b)domestic storage of final products.
(Application for Registration of Manufacturing)
Article 114-9(1)An application for a registration of manufacturing medical devices or in-vitro diagnostics prescribed in Article 23-2-3, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 63-2 to a prefectural governor who is responsible for activities related to the authority pursuant to the authority for the registration pursuant to the provisions of Article 80 of the Order.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the written applications at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)documents which show the applicant (an officer engaged in the services in case of a corporation) does not fall under Article 5, item (iii), (e) and (f) of the Act;
(iii)if a person other than an applicant is a technical supervisor of medical devices or manufacturing supervisor of in-vitro diagnostics, a copy of an employment agreement and other documents proving an employment relationship between the applicant and the technical supervisor of medical devices or the manufacturing supervisor of in-vitro diagnostics;
(iv)documents showing a technical supervisor of medical devices is one set forth in Article 114-53 and that a manufacturing supervisor of in-vitro diagnostics is a pharmacist;
(v)drawings identifying the location of manufacturing facility to be registered;
(vi)if an applicant receives another license or registration for manufacturing, a copy of the license certificate or the registration certificate for manufacturing.
(3)The provisions of Article 9 apply mutatis mutandis to an application prescribed in paragraph (1).In this case, "prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward)" in the same Article is deemed to be replaced with "prefectural governor".
(Form of Registration Certificate for Manufacturing)
Article 114-10The registration certificate of manufacturing medical devices or in-vitro diagnostics is to be based on Form No. 63-3.
(Application for Updated Issuance of Registration Certificate of Manufacturing)
Article 114-11A written application prescribed in Article 37-9, paragraph (2) of the Order is to be based on Form No. 3.
(Application for Reissuance of Registration Certificate of Manufacturing)
Article 114-12A written application prescribed in Article 37-10, paragraph (2) of the Order is to be based on Form No. 4.
(Application for Renewal of Registration of Manufacturing)
Article 114-13(1)An application for renewal of registration of manufacturing medical devices or in-vitro diagnostics prescribed in Article 23-2-3, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 63-4 to a prefectural governor who is responsible for activities related to the registration authority pursuant to the provisions of Article 80 of the Order.
(2)The registration certificate concerning the application must be attached to the written application prescribed in the preceding paragraph.
(Matters to Be Included in Registry of Registration of Manufacturing)
Article 114-14Matters to be included in the registry of registration prescribed in Article 23-2-3, paragraph (1) of the Act provided in Article 37-12, paragraph (1) of the Order are as follows:
(i)the registration number and date;
(ii)the name and address of the manufacturer;
(iii)the name and location of the manufacturing facility;
(iv)the name and address of a technical supervisor of medical devices or a manufacturing supervisor of in-vitro diagnostics of the manufacturing facility;
(v)in cases where the manufacturer is granted another license or registration for manufacturing, the criteria for the manufacturing license and the license number or registration number.
(Application for Registration of Foreign Manufacturers of Medical Devices)
Article 114-15(1)An application for a registration of a foreign manufacturer of medical devices prescribed in Article 23-2-4, paragraph (1) of the Act is to be made by submitting written applications based on Form No. 63-5 (the original and a duplicate) to the Minister of Health, Labour and Welfare via the PMDA.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)documents which show the applicant (or an officer responsible for the business if the applicant is a corporation) does not fall under Article 5, item (iii), (e) and (f) of the Act;
(ii)a resume of a person in charge of the manufacturing facility;
(iii)drawings identifying the location of a manufacturing facility to be registered.
(Application, Mutatis Mutandis)
Article 114-16(1)The provisions of Articles 114-10 to 114-14 apply mutatis mutandis to the registration prescribed in Article 23-2-4, paragraph (1) of the Act.
(2)In cases prescribed in the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms and phrases set forth in the middle column of the same table are deemed to be replaced with those set forth in the right-hand column of that table.
Article 114-10
manufacturing medical devices or in-vitro diagnostics
foreign manufacturer of medical devices, etc.
Form No. 63-3
Form No. 63-6
Article 114-11
Article 37-9, paragraph (2)
Article 37-15, paragraph (2)
Article 114-12
Article 37-10, paragraph (2)
Article 37-16, paragraph (2)
Article 114-13, paragraph (1)
Act
Act as applied mutatis mutandis pursuant to Article 23-2-4, paragraph (2) of the Act
manufacturing medical devices or in-vitro diagnostics
foreign manufacturer of medical devices, etc.
Form No. 63-4
Form No. 63-7
a prefectural governor who is required to administer or carry out activities related to the authority for the registration pursuant to the provisions of Article 80 of the Order
the Minister of Health, Labour and Welfare via the PMDA
Article 114-14
Article 23-2-3, paragraph (1) of the Act provided in Article 37-12, paragraph (1)
Article 23-2-4, paragraph (1) of the Act provided in Article 37-18
Article 114-14, item (ii)
manufacturer
foreign manufacturer of medical devices, etc.
Article 114-14, item (iv)
technical supervisor of medical devices or a manufacturing supervisor of in-vitro diagnostics
responsible person
Article 114-14, item (v)
manufacturer
foreign manufacturer of medical devices, etc.
license or registration for manufacturing
accreditation of a foreign manufacturer of pharmaceuticals, etc., or a foreign manufacturer of regenerative medicine products, or registration of foreign manufacturer of medical devices etc.
criteria and license number for manufacturing license
criteria and accreditation number for accreditation
(Application for Marketing Approval of Medical Devices and In-Vitro Diagnostics)
Article 114-17(1)An application for marketing approval of medical devices or in-vitro diagnostics prescribed in Article 23-2-5, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 63-8 (the original copy and two duplicates) to the Minister of Health, Labour and Welfare.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare who is in charge of receiving the written applications at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)a copy of a license certificate for marketing concerning the items;
(ii)documents clearly indicating that materials to be marketed by an applicant are medical devices or in-vitro diagnostics provided in Article 23-2-8, paragraph (1), item (ii) of the Act and other necessary documents when applying for an approval prescribed in Article 23-2-5, paragraph (1) of the Act pursuant to the provisions of Article 23-2-8, paragraph (1) of the Act.
(Cases Where Materials Are Inappropriate as Medical Devices or In-Vitro Diagnostics)
Article 114-18Cases where medical devices or in-vitro diagnostics are specified by Order of the Ministry of Health, Labour and Welfare as not being appropriate as those prescribed in Article 23-2-5, paragraph (2), item (iii), (c) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) are the cases where properties or qualities of the medical devices or in-vitro diagnostics concerning the application are remarkably inappropriate with regard to health and hygiene.
(Data to Be Attached to Written Applications for Approval)
Article 114-19(1)Data to be attached to a written application prescribed in Article 114-17, paragraph (1) or Article 114-24, paragraph (1) pursuant to the provisions of Article 23-2-5, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) is the data set forth in each of the following items according to the structure and performance, etc. of medical devices or vitro diagnostic pharmaceuticals concerning criteria for approval and applications set forth in each of the following items:
(i)approval of medical devices: the following data:
(a)data concerning the development process and conditions of use in foreign countries, etc.;
(b)data concerning verification of design and development;
(c)data concerning compliance with the standards provided in Article 41, paragraph (3) of the Act;
(d)data concerning risk management;
(e)data concerning manufacturing methods;
(f)data concerning test results of clinical studies or data recognized by the Minister of Health, Labour and Welfare as fungible with respect to the same;
(g)data concerning the plan for post-marketing investigation provided in Article 2, paragraph (1) of the Ministerial Order on Standards for Post-Marketing Surveillance and Test of Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 38 of 2005);
(h)data concerning matters to be indicated on package inserts provided in Article 63-2, paragraph (1) of the Act;
(ii)approval of in-vitro diagnostics: the following data:
(a)data concerning the development process and conditions of use in foreign countries, etc.;
(b)data concerning specification settings;
(c)data concerning stability;
(d)data concerning the compliance with the standards provided in Article 41, paragraph (3) of the Act;
(e)data concerning performance;
(f)data concerning risk management;
(g)data concerning manufacturing methods;
(h)data concerning test results of clinical performance study.
(2)Notwithstanding the provisions of the preceding paragraph, with respect to the data to be attached to written applications prescribed in Article 114-17, paragraph (1) or Article 114-24, paragraph (1) pursuant to provisions of Article 23-2-5, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article), if it is recognized that matters concerning the application exist in the public domain in the medical and pharmaceutical fields, or there are other reasonable grounds why the attachment of data is not required, the attachment is not required.
(3)A test required to create data set forth in each of the items of paragraph (1) must be conducted at a test facility, etc. that has a facility, devices, and employees required to ensure the reliability of test results and is recognized to be properly operated and managed.
(4)When the data casts a doubt on whether medical devices or in-vitro diagnostics pertaining to an application have sufficient quality, efficacy, or safety for the application, an applicant must submit the data to the Minister of Health, Labour and Welfare if the test required to create the data has not been conducted at a test facility, etc. provided in the preceding paragraph.
(5)Beyond what is set forth in each of the items of paragraph (1) and what is provided in the preceding paragraph, if the Minister of Health, Labour and Welfare acknowledges the necessity for an examination for approval of medical devices or in-vitro diagnostics and asks for the submission of samples of medical devices or in-vitro diagnostics, the applicant must submit the data to the minister.
(Suspension of Submission of Data to Be Attached to Written Applications for Approval of Medical Devices or In-Vitro Diagnostics concerning Special Approval)
Article 114-20When an applicant acknowledges that data set forth in paragraph (1), item (i), (a) to (e), (g) and (h), or item (ii), (a) to (g) of the preceding Article cannot be attached to applications for medical devices or in-vitro diagnostics to be marketed upon approval prescribed in Article 23-2-5 of the Act under Article 23-2-8, paragraph (1) of the Act, the Minister of Health, Labour and Welfare may suspend the submission for a reasonable period of time.
(Medical Devices or In-Vitro Diagnostics for Which Data Is Collected and Prepared According to Standards Specified by the Minister of Health, Labour and Welfare)
Article 114-21Medical devices or in-vitro diagnostics specified by Order of the Ministry of Health, Labour and Welfare provided in the second sentence of Article 23-2-5, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) are medical devices provided in paragraph (1) of the same Article.
(Standards of Reliability of Application Data)
Article 114-22Data provided in the second sentence of Article 23-2-5, paragraph (3) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) must be collected and prepared using the following methods beyond what is specified by the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 37 of 2005) and the Ministerial Order on Standards for Clinical Studies of Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 36 of 2005):
(i)the data is correctly prepared based on results of the investigation or the test conducted for the purpose of preparing the data;
(ii)in cases where results of the investigation or the test in the preceding item cast a doubt on whether medical devices concerning an application have sufficient quality, efficacy, or safety pertaining to the application, results of the investigation and the test are reviewed and evaluated and the results are described in the data;
(iii)data on which the data is based is preserved until the date of disposition when the approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act is provided or not; provided, however, that this does not apply to the case where it is recognized that the nature of the data makes it extremely difficult to preserve.
(Data That Can Be Replaced with Documents Certifying the Registration in Drug Master File)
Article 114-23A person who intends to apply for an approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act may replace a part of the data set forth in Article 114-19, paragraph (1), item (i), (e), or item (ii), (g) from among the data prescribed in Article 23-2-5, paragraph (3) of the Act with a copy of a registration certificate prescribed in Article 280-4, paragraph (1), an agreement with a registered manufacturer of active ingredients, etc. regarding the active ingredients, etc. and other documents certifying the use of the active ingredients, etc. as items pertaining to the application.
(Approval of Partial Changes of Approved Matters)
Article 114-24(1)An application for approval of partial changes to marketing approval matters for medical devices or in-vitro diagnostics prescribed in Article 23-2-5, paragraph (11) of the Act is to be made by submitting a written application based on Form No. 63-9 (the original copy and two duplicates) to the Minister of Health, Labour and Welfare.
(2)When an application for approval prescribed in Article 23-2-5, paragraph (11) of the Act is to be made pursuant to the provisions of Article 23-2-8, paragraph (1) of the Act, documents set forth in Article 114-17, paragraph (2), item (ii) must be attached to a written application prescribed in the preceding paragraph.
(Scope of Minor Changes of Approved Matters)
Article 114-25(1)Minor changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-5, paragraph (11) of the Act concerning medical devices are ones other than those set forth in each of the following items:
(i)addition, change, or deletion of purposes of use or effects;
(ii)changes concerning the inactivation or removal method of pathogenic factors;
(iii)beyond changes set forth in the preceding two items, changes that influence the quality, efficacy, and safety of the product and are found by the Minister of Health, Labour and Welfare to require an approval prescribed in Article 23-2-5, paragraph (11) of the Act.
(2)Minor changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-5, paragraph (11) of the Act concerning in-vitro diagnostics are ones other than those set forth in each of the following items:
(i)addition, change, or deletion of purposes of uses;
(ii)addition, change, or deletion of components concerning reaction system;
(iii)beyond changes set forth in the preceding two items, changes that influence the quality, efficacy, and safety of the product and are found by the Minister of Health, Labour and Welfare to require an approval prescribed in Article 23-2-5, paragraph (11) of the Act.
(Notification of Minor Changes)
Article 114-26(1)A notification under Article 23-2-5, paragraph (12) of the Act is to be made by submitting a written application based on Form No. 63-10 (the original and a duplicate) to the Minister of Health, Labour and Welfare.
(2)The notification prescribed in the preceding paragraph must be made within 30 days after making minor changes prescribed in Article 23-2-5, paragraph (11) of the Act.
(3)In applying the provisions of paragraph (1) when the Minister of Health, Labour and Welfare decides to have the PMDA undergo an examination on medical devices, etc. provided in Article 23-2-7, paragraph (1) of the Act pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) and (6) of the Act), the term "Minister of Health, Labour and Welfare" in paragraph (1) is deemed to be replaced with "PMDA".
(Matters to Be Included in Registry of Approval)
Article 114-27Matters to be included in the registry of approval prescribed in Article 23-2-5, paragraph (1) and (11) of the Act provided in Article 37-19 of the Order are as follows:
(i)the approval number and date;
(ii)the name and address of a person who obtained an approval;
(iii)the type and license number for the marketing license of a person who obtained an approval;
(iv)the name of the manufacturing facility of the item;
(v)the registration number for manufacturers or for foreign manufacturers of medical devices accepted by a manufacturing facility of the item;
(vi)the name of the item;
(vii)the shape, structure, and principle of the item;
(viii)the purpose of use or effect of the item;
(ix)the usage of the item.
(Application for Compliance Investigation of Medical Devices, etc.)
Article 114-28(1)The application for the investigation under Article 23-2-5, paragraph (6) or (8) of the Act (including cases where those provisions are applied mutatis mutandis pursuant to paragraph (11) of the same Article) (hereinafter referred to as the "compliance investigation of medical devices, etc." in this chapter) is to be conducted by filing a written application based on Form No. 63-11 with the Minister of Health, Labour and Welfare.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph:
(i)data concerning the manufacturing and quality management of the item concerning the compliance investigation of medical devices, etc.;
(ii)data concerning the manufacturing and quality management by holders of marketing authorization and at all manufacturing facilities (meaning manufacturing facilities provided in Article 23-2-3, paragraph (1) of the Act; hereinafter the same applies in this chapter) pertaining to the compliance investigation of medical devices, etc.
(3)In applying the provisions of paragraph (1) when the Minister of Health, Labour and Welfare decides to have the PMDA undergo a compliance investigation pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act, the term "Minister of Health, Labour and Welfare" in paragraph (1) is deemed to be replaced with "PMDA".
(Notification of Results of Compliance Investigation of Medical Devices, etc.)
Article 114-29A notification of the results of the compliance investigation of medical devices, etc. to be given by a person conducting a compliance investigation of medical devices, etc. (meaning a person conducting a compliance investigation of medical devices, etc. provided in Article 37-23 of the Order) to a person granting licenses for marketing medical devices (meaning a person granting licenses for marketing medical devices provided in the same Article) pursuant to the provisions of the same Article is to be given by using a written notice based on Form No. 63-12.
(Matters to Be Included in Registry of Compliance Investigation of Medical Devices, etc.)
Article 114-30matters to be included in the registry concerning the compliance investigation of medical devices, etc. provided in Article 37-24 of the Order are as follows:
(i)investigation results and notification date;
(ii)the name of the item;
(iii)the name and address of a person who intends to receive or has received a marketing approval for the item;
(iv)the approval number and date (limited to in the case where the person set forth in the preceding item has already obtained the marketing approval of the item);
(v)the criteria provided in Article 23-2-5, paragraph (7), item (i) of the Act, which the item belongs to;
(vi)the name and location of the manufacturing facility of the item;
(vii)the name and the address of a manufacturer of the item or a foreign manufacturer of medical devices;
(viii)the registration number and date for manufacturers or foreign manufacturers of medical devices in the preceding item;
(ix)in cases of issuing a conformity certificate, its number;
(x)in cases of issuing a certificate of additional investigation results provided in Article 114-33, paragraph (2), its number;
(xi)in cases of conducting an investigation provided in Article 114-34, paragraph (2), a report that the investigation has been conducted and criteria provided in the same paragraph for medical devices or in-vitro diagnostics, which are targets of the investigation.
(Changes to Approved Matters Excluded from Compliance Investigation of Medical Devices, etc.)
Article 114-31Changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 37-25, paragraph (1) of the Order do not influence the methods to control manufacturing or quality of the item.
(Manufacturing Processes at Manufacturing Facilities Not Requiring Compliance Investigations of Medical Devices, etc. Even When the Manufacturing Facilities Are Not the Same)
Article 114-32The manufacturing processes specified by Order of the Ministry of Health, Labour and Welfare as prescribed in Article 23-2-5, paragraph (7), item (ii) of the Act are ones other than those set forth in each of the following items:
(i)sterilization;
(ii)storage of final products;
(iii)such other manufacturing processes recognized by the Minister of Health, Labour and Welfare as suitable.
(Cases Where Additional Investigations Are Required)
Article 114-33(1)The Minister of Health, Labour is to conduct a document-based or on-site conformity investigation under Article 23-2-5, paragraph (8) of the Act (hereinafter referred to as "additional investigation") in cases set forth in the following items:
(i)cases where medical devices related to an approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act (hereinafter referred to as an "approval" in this Article) fall under any of the following criteria prescribed in (a) to (f) (limited to the cases where a valid conformity certificate (meaning the conformity certificate prescribed in Article 23-2-6, paragraph (1) of the Act or the conformity certificate prescribed in Article 23-2-24, paragraph (1) of the Act; hereinafter the same applies in this Article) concerning the medical device has been issued, and where no investigation that is to be necessary depending on characteristics of the criteria has been conducted in a compliance investigation of medical devices, etc. related to the conformity certificate or an investigation under Article 23-2-23, paragraph (3) or (5) of the Act (hereinafter referred to as the "compliance investigation of medical devices, etc." in this Article):
(a)those with pharmaceuticals or regenerative medicine products integrated as a part of their raw materials;
(b)specified biological products;
(c)micro machines (meaning medical devices or in-vitro diagnostics using electricity and other energy and with a diameter of 3 millimeters or less and part diameter of 1 millimeter or less; hereinafter the same applies in item (iii), (b));
(d)those for which nano materials (meaning materials whose length or width or height is 1 nanometer or greater and 100 nanometers or less; hereinafter the same applies in item (iii), (c)) are used in the manufacturing process;
(e)those that is anticipated that all of the medical device is finally absorbed into a human body (excluding those set forth in (b));
(f)designated medical devices;
(ii)cases where medical devices pertaining to an approval fall under all of (a) to (d) below:
(a)sterilized medical devices (meaning a medical device sterilized in the manufacturing process);
(b)a valid conformity certificate is issued for the medical devices;
(c)the method of sterilizing the medical devices is different from that of sterilizing medical devices undergoing the compliance investigation of medical devices, etc. pertaining to the conformity certificate prescribed in (b);
(d)with respect to a manufacturing facility where the medical devices are sterilized, neither a conformity certificate nor certificate of additional investigation results provided in the following paragraph on which there is a mention of the manufacturing facility concerning the same sterilization method as the method of sterilizing the medical device (limited to proper investigation results) has been issued within the last five years;
(iii)cases where in-vitro diagnostics related to an approval fall under any of the following criteria prescribed in (a) through (c) (limited to cases where a valid conformity certificate has been issued for the in-vitro diagnostics, and where no investigation that is to be necessary depending on characteristics of the criteria has been conducted in a compliance investigation of medical devices, etc. related to the conformity certificate):
(a)biological products;
(b)micro machines;
(c)those for which nano materials are used in the manufacturing process;
(iv)cases where medical devices or in-vitro diagnostics pertaining to an approval fall under all of (a) through (c) below:
(a)a valid conformity certificate is issued for the medical devices or the in-vitro diagnostics;
(b)from among manufacturing facilities manufacturing the medical devices or in-vitro diagnostics, with respect to the manufacturing processes set forth in each of the items of the preceding Article, some manufacturing facilities are the same as those mentioned on a conformity certificate prescribed in (a) (referred to as the "mentioned manufacturing facilities" in (c)) and others are not the same (referred to as the "exceptional manufacturing facilities" in (c));
(c)neither a conformity certificate on which there is a mention of the exceptional manufacturing facility (if there are more than one, each exceptional manufacturing facility; hereinafter the same applies in this item) (limited to those with a mention of the exceptional manufacturing facilities where the manufacturing process includes the manufacturing processes at the exceptional manufacturing facilities pertaining to the medical devices or in-vitro diagnostics) nor a certificate of additional investigation results provided in the following paragraph on which there is a mention of the exceptional manufacturing facility (limited to those with a mention of the exceptional manufacturing facilities where the manufacturing process includes the manufacturing processes at the exceptional manufacturing facilities pertaining to the medical devices or the in-vitro diagnostics, and with an applicable investigation results) has been issued within the past five years;
(v)cases where medical devices or in-vitro diagnostics pertaining to an approval fall under all of (a) through (c) below:
(a)a valid conformity certificate is issued for the medical devices or the in-vitro diagnostics related to the approval and the applicant shown in the conformity certificate is a person other than the person who intends to receive the approval;
(b)the status of a person receiving approval for medical devices or a person certified for medical devices for medical devices or in-vitro diagnostics related to the conformity certificate prescribed in (a) is succeeded to a person who intends to receive the approval based on Article 23-2-11, paragraph (1) or (2) of the Act or Article 23-3-2, paragraph (1) or (2) of the Act;
(c)no additional investigation under this paragraph (including as applied mutatis mutandis pursuant to Article 118, paragraphs (1) and (2)) has been conducted as to medical devices or in-vitro diagnostics which belong to the same criteria provided in Article 23-2-5, paragraph (7), item (i) of the Act as medical devices or in-vitro diagnostics related to the conformity certificate prescribed in (a) belong to (limited to the medical devices or in-vitro diagnostics manufactured at the same manufacturing facility as all manufacturing facilities manufacturing medical devices or in-vitro diagnostics related to the conformity certificate (excluding those undergoing only the manufacturing processes provided in each of the items of the preceding Article from among the manufacturing processes of medical devices or in-vitro diagnostics related to the conformity certificate)) since the day of succession prescribed in (b);
(vi)other cases which the Minister of Health, Labour and Welfare finds necessary.
(2)In cases of conducting additional investigations prescribed in the preceding paragraph, the Minister of Health, Labour and Welfare is to issue a certificate to show the results based on Form No. 63-13 (hereinafter referred to as a "certificate of additional investigation results").
(3)In applying the provisions of the preceding two paragraphs when it is determined to have the PMDA undergo a compliance investigation of medical devices, etc. pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act, the term "Minister of Health, Labour and Welfare" in these provisions is deemed to be replaced with "PMDA".
(Issuance of Conformity Certificate)
Article 114-34(1)A conformity certificate (meaning the conformity certificate prescribed in Article 23-2-6, paragraph (1) of the Act; hereinafter the same applies in this Article to Article 114-36) is to be based on Form No. 63-14.
(2)In issuing a conformity certificate, if the investigation under Article 23-2-5, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) related to the conformity certificate is regarding medical devices or in-vitro diagnostics falling under any of the following criteria prescribed in paragraph (1), item (i), (a) through (f) or item (iii), (a) through (c) of the preceding Article, documents showing the investigation required depending on characteristics of the criteria is undergone are also to be issued.
(3)In cases where a person to whom a conformity certificate is issued holds another conformity certificate with the same content (excluding the validity period) as the relevant conformity certificate, the person is to return it.
(Application for Updated Issuance of Conformity Certificate)
Article 114-35A written application prescribed in Article 37-26, paragraph (2) of the Order is to be based on Form No. 3.
(Application for Reissuance of Conformity Certificate)
Article 114-36A written application prescribed in Article 37-27, paragraph (2) of the Order is to be based on Form No. 4.
(Application to the PMDA for Examination or Investigation Concerning Marketing Approval of Medical Devices or In-Vitro Diagnostics)
Article 114-37(1)When it is determined to have the PMDA undergo an examination for approval prescribed in Article 23-2-5 of the Act pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act, an applicant for approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act concerning medical devices or in-vitro diagnostics provided in Article 37-29, paragraph (1) of the Order must apply to the PMDA for the examination.
(2)When it is determined to have the PMDA undergo the investigation prescribed in the second sentence of Article 23-2-5, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act, an applicant for the approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act concerning medical devices or in-vitro diagnostics provided in Article 37-29, paragraph (1) of the Order must apply to the PMDA for the investigation.
(3)The application prescribed in the preceding two paragraphs is to be made by attaching a written application based on Form No. 63-15 to a written application for approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act for the item concerning the application.
(4)The provisions of Article 114-19, paragraph (5) apply mutatis mutandis to an examination for approval prescribed in Article 23-2-5 of the Act and an investigation prescribed in paragraph (5) of the same Article (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) (hereinafter referred to as an "examination, etc. on medical devices, etc." in the following Article) undergone by the PMDA pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act.In this case, "beyond what is set forth in each of the items of paragraph (1) and provided in the preceding paragraph, the Minister of Health, Labour and Welfare " is deemed to be replaced with "the PMDA", "examination" with "examination or an investigation prescribed in Article 23-2-5, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article)", and the "Minister of Health, Labour and Welfare" with the "Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Examination on Medical Devices, etc. by the PMDA)
Article 114-38(1)A notification of results of an examination, etc. on medical devices, etc. to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-2-7, paragraph (5) of the Act is to be given by using a notification based on Form No. 63-16.
(2)A notification of investigation results prescribed in Article 23-2-5, paragraphs (6) and (8) of the Act (including as applied mutatis mutandis pursuant to paragraph (11) of the same Article) to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 23-2-7, paragraph (5) of the Act is to be given by using a notification based on Form No. 63-12.
(3)A notice of a notification status under Article 23-2-5, paragraph (12) of the Act to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-2-7, paragraph (5) of the Act is to be given by using a notification based on Form No. 29.
(Application for Evaluation of Results of Usage of Medical Devices or In-Vitro Diagnostics)
Article 114-39An application for evaluation of the results of usage of medical devices or in-vitro diagnostics prescribed in Article 23-2-9, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 63-17 (the original copy and two duplicates)
(Data to Be Attached to Written Applications for Evaluation of Results of Usage)
Article 114-40(1)Data to be attached to a written application prescribed in the preceding Article pursuant to the provisions of Article 23-2-9, paragraph (4) of the Act is data concerning the results of usage of medical devices or in-vitro diagnostics pertaining to an application.
(2)The provisions of Article 114-19, paragraph (3) apply mutatis mutandis to the data provided in the preceding paragraph.
(3)The provisions of Article 114-19, paragraph (4) apply mutatis mutandis to an applicant for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act.
(4)Beyond what it provided in Article 114-19, paragraph (4) as applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph, if the Minister of Health, Labour and Welfare acknowledges it necessary for evaluation of the results of usage of medical devices or in-vitro diagnostics and asks for submission of data, an applicant must submit the data to the Minister of Health, Labour and Welfare.
(Scope of Medical Devices or In-Vitro Diagnostics Concerning Investigation on Evaluation of Results of Usage)
Article 114-41Medical devices or in-vitro diagnostics specified by Order of the Ministry of Health, Labour and Welfare provided in the second sentence of Article 23-2-9, paragraph (4) of the Act are those provided in paragraph (1) of the same Article.
(Standards for Reliability of Application Data for Evaluation of Results of Usage)
Article 114-42The provisions of Article 114-22 apply mutatis mutandis to the data provided in the second sentence of Article 23-2-9, paragraph (4) of the Act.In this case, "the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 37 of 2005)" in the same Article is deemed to be replaced with "the Ministerial Order on Standards for Post-Marketing Surveillance and Test of Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 38 of 2005), the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety Medical Devices (Order of the Ministry of Health, Labour and Welfare No. 37 of 2005)" and "the date of disposition whether an approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act is given or not " with " the final date of evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act".
(Reports of Investigation on Results of Usage of Medical Devices or In-Vitro Diagnostics and Results)
Article 114-43(1)Investigations prescribed in Article 23-2-9, paragraph (6) of the Act to be conducted by a person with an approval prescribed in Article 23-2-5 of the Act for medical devices or in-vitro diagnostics provided in Article 23-2-9, paragraph (1) of the Act are to be conducted on diseases, disability disabilities, or death suspected to be caused by any failure in the medical devices or the in-vitro diagnostics, or infectious diseases suspected to be caused by their use, and other results of usage for an investigation period provided in paragraph (1) of the same Article (the extended period if the period is extended pursuant to the provisions of paragraph (2) of the same Article).
(2)A report to the Minister of Health, Labour and Welfare under Article 23-3-9, paragraph (6) of the Act or a report to the PMDA under the first sentence of Article 23-2-10, paragraph (2) of the Act must be given every year from the date instructed by the Minister of Health, Labour and Welfare at the time of approval for marketing medical devices or in-vitro diagnostics related to the investigation (for each period instructed by the Minister of Health, Labour and Welfare in cases of medical devices or in-vitro diagnostics instructed by the Minister of Health, Labour and Welfare) within two months after the expiration of a period.
(3)A notification of receiving a report prescribed in the preceding paragraph to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of the second sentence of Article 23-2-10, paragraph (2) of the Act is to be given by using a notification based on Form No. 31.
(Application to the PMDA for Confirmation or Investigation Concerning Evaluation of Results of Usage)
Article 114-44(1)When it is determined to have the PMDA conduct the confirmation under Article 23-2-9, paragraph (3) of the Act or the investigation under paragraph (5) of the same Article (hereinafter referred to as the "confirmation of medical devices, etc." in this Article and the following Article) pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-10, paragraph (1) of the Act, the applicant for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act concerning medical devices or in-vitro diagnostics provided in Article 37-31 of the Order must apply to the PMDA for the confirmation of medical devices, etc.
(2)In filing an application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 63-18 to a written application for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act of items concerning the application.
(3)the provisions of Article 114-40, paragraph (4) apply mutatis mutandis to the confirmation of medical devices, etc. conducted by the PMDA pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-10, paragraph (1) of the Act.In this case, "the Minister of Health, Labour and Welfare ...beyond what is provided in Article 114-19, paragraph (4) as applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph" in the same paragraph is deemed to be replaced with "the PMDA", "evaluation of the results of usage" with "confirmation under Article 23-2-9, paragraph (3) of the Act or the investigation paragraph (5) of the same Article", and "to the Minister of Health, Labour and Welfare" with "to the Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Confirming Medical Devices in Evaluation of Results of Usage by the PMDA)
Article 114-45A notification of results of confirming medical devices, etc. to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 23-2-7, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 23-2-10, paragraph (1) of the Act is to be given by using a notification based on Form No. 63-19.
(Notification of Succession)
Article 114-46(1)The data and the information specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-11, paragraph (1) of the Act is as follows:
(i)data submitted at the time of application for registration prescribed in Article 23-2-3, paragraph (1) of the Act or Article 23-2-4, paragraph (1) of the Act;
(ii)data submitted at the time of application for approval prescribed in Article 23-2-5, paragraph (1) of the Act and application for approval of partial change of approved matters prescribed in paragraph (11) of the same Article, and data which the submitted data is based on;
(iii)data submitted at the time of application for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act, and data which the submitted data is based on;
(iv)data submitted at the time of the report under Article 23-2-9, paragraph (6) of the Act, and data which the submitted data is based on;
(v)the records and data related to the records concerning the designated medical devices under Article 68-5, paragraph (1) of the Act;
(vi)records and data related to biological products under Article 68-22, paragraph (1) of the Act;
(vii)the data and the information concerning the manufacturing or quality control operations;
(viii)the data and the information concerning the post-marketing safety control activities;
(ix)other documents and information concerning quality, efficacy, and safety.
(2)Notification under Article 23-2-11, paragraph (3) of the Act is to be carried out by submitting a notification based on Form No. 63-20 (the original and a duplicate) to the Minister of Health, Labour and Welfare.
(3)A document proving that an applicant succeeds to the status of a person receiving approval for medical devices must be attached to the notification prescribed in the preceding paragraph.
(Notification of Marketing)
Article 114-47(1)Notification under Article 23-2-12, paragraph (1) of the Act is to be made by submitting a written notification based on Form No. 63-21 (the original and two duplicates) to the Minister of Health, Labour and Welfare.
(2)Notification of changes under Article 23-2-12, paragraph (2) of the Act is to be made by submitting a notification based on Form No. 40 (the original and two duplicates) to the Minister of Health, Labour and Welfare.
(3)Copies of inserts of items related to the notification must be attached to the notification prescribed in paragraph (1) pertaining to medical devices.
(4)In applying the provisions of paragraphs (1) and (2) in cases of notifying the PMDA pursuant to the provisions of Article 23-2-13, paragraph (1) of the Act, the "the original and two duplicates) when submitting to the Minister of Health, Labour and Welfare" in those provisions is deemed to be replaced with "the original and a duplicate when submitting to the PMDA".
(Notice Concerning Receipt of Notification of Marketing by the PMDA)
Article 114-48A notice of receiving a notification for marketing to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-2-13, paragraph (2) of the Act is to be given by using a notification based on Form No. 41.
(Standards for Marketing Directors of Medical Devices)
Article 114-49(1)The standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-14, paragraph (1) of the Act concerning a person responsible for the manufacturing, quality, and post-marketing safety controls of specially-controlled medical devices or controlled medical devices stipulate that the person is to fall under any of the following items:
(i)a person who has completed an advanced course in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry at university, etc.;
(ii)a person who has experience in engaging in the work of quality control or post-marketing safety control of pharmaceuticals, medical devices, or regenerative medicine products for three years or more after graduating from a former secondary school, a high school, or a school equivalent or greater than the same by completing an advanced course in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry;
(iii)a person who has completed a skill training course by a lecturer registered by the Minister of Health, Labour and Welfare separately pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare after engaging in the work of quality control or post-marketing safety control of pharmaceuticals, medical devices, or regenerative medicine products for five years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(2)The standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-14, paragraph (1) of the Act concerning a person responsible for manufacturing supervisor, the quality control and the post-marketing safety control of cosmetics general of medical devices stipulate that the person is to fall under any of the following items:
(i)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such schools by completing an advanced course in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry;
(ii)a person who has graduated from a former secondary school, a high school, or a school equivalent or greater than the same by mastering subjects concerning physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry and has experience in engaging in the work of quality control or post-marketing safety control of pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices, or regenerative medicine products for three years or more;
(iii)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding two items.
(Matters to Be Observed by Marketing Directors of Medical Devices)
Article 114-50Matters to be observed by a marketing director of medical devices, etc. provided in Article 23-2-14, paragraph (2) of the Act are as follows:
(i)being knowledgeable about laws and regulations and practices concerning operations related to the manufacturing control, quality control and post-marketing safety control and fairly and properly undertaking the operations;
(ii)expressing a necessary opinion in documents to a holder of marketing authorization and maintaining a copy for five years if it is recognized that it is necessary for fairly and properly undertaking the operations;
(iii)closely cooperating with a person responsible for operations concerning the quality control of medical devices or in-vitro diagnostics (hereinafter referred to as a "domestic quality assurance administrator") and a person responsible for the operation related to the post-marketing safety control (hereinafter referred to as a "safety control manager of medical devices, etc.").
(Respect for Opinions of Technical Supervisors of Medical Devices)
Article 114-51Manufacturers of medical devices or in-vitro diagnostics must respect opinions given by a technical supervisor of medical devices or a manufacturing supervisor of in-vitro diagnostics who finds it necessary to satisfy the obligation provided in Article 8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-14, paragraph (4) or (6) or Article 68-16, paragraph (2) of the Act.
(Records on Manufacturing and Tests)
Article 114-52A technical supervisor of medical devices or a manufacturing supervisor of in-vitro diagnostics at manufacturing facilities for medical devices or in-vitro diagnostics must prepare records concerning manufacturing and tests and other records on control at the manufacturing facility and must preserve records for three years (the period resulting from the addition of one year to the validity period in cases where it is required to enter the validity period of medical devices or in-vitro diagnostics in the record); provided, however, that this does not apply if the preparation and the retention of records are mandated pursuant to other provisions of this Regulation or those of other pharmaceutical laws and regulations.
(Qualifications for Technical Supervisors of Medical Devices)
Article 114-53(1)Manufacturers of medical devices must assign a technical supervisor of medical devices who falls under any of the following items pursuant to the provisions of Article 23-2-14, paragraph (3) of the Act at every manufacturing facility:
(i)a person who has completed an advanced course in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry at university, etc.;
(ii)a person who has experience in engaging in the work of manufacturing medical devices for three years or more after they have graduated from a former secondary school, a high school, or a school equivalent or greater than the same by completing an advanced course concerning physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry;
(iii)a person who has completed a skill training course by a lecturer registered by the Minister of Health, Labour and Welfare separately pursuant to the provisions of Order of the Ministry of Health, Labour and Welfare after engaging in the work of manufacturing medical devices for five years or more;
(iv)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding three items.
(2)At a manufacturing facility manufacturing only general medical devices, notwithstanding the provisions of the preceding paragraph, a person falling under any of the following items may be assigned as a technical supervisor of medical devices:
(i)a person who has graduated from a former secondary school or a high school or a school equivalent or superior to such school by completing an advanced course in physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry;
(ii)a person who has experience in engaging in the work of manufacturing medical devices for three years or more after graduating from a former secondary school, a high school, or a school equivalent or greater than the same by mastering subjects concerning physics, chemistry, biology, engineering, information science, metallurgy, electricity, mechanics, pharmacology, medicine, or dentistry;
(iii)a person who is recognized by the Minister of Health, Labour and Welfare as having knowledge and experience equal to or greater than the persons set forth in the preceding two items.
(3)At a manufacturing facility where only designing is carried out in the manufacturing process of medical devices, notwithstanding the provisions of the preceding two paragraphs, a person who has been designated as a person responsible for the department related to the design by a manufacturer may be assigner as a technical supervisor of medical devices.
(Matters to Be Observed by Holders of Marketing Authorization for Medical Devices or In-Vitro Diagnostics)
Article 114-54Matters to be observed by a holder of marketing authorization for medical devices or in-vitro diagnostics provided in Article 23-2-15, paragraph (1) of the Act are as follows:
(i)consideration required for proper marketing according to pharmaceutical laws and regulations;
(ii)proper manufacturing and quality control of products to be marketed according to the provisions of Article 114-58, paragraph (1);
(iii)proper post-marketing safety control of products to be marketed;
(iv)a holder of marketing authorization for biological products (limited to medical devices) appoints an assistant with bacteriological knowledge to a marketing director of medical devices, etc., in case where any of the marketing director of medical devices, a domestic quality assurance administrator, and a safety control manager of medical devices, etc. have no bacteriological knowledge;
(v)a holder of marketing authorization for medical devices appoints an assistant with relevant expertise to a marketing director of medical devices, etc., in case where any of the marketing director of medical devices, a domestic quality assurance administrator, and a safety control manager of medical devices, etc. have no expertise concerning characteristics of items to be marketed;
(vi)necessary considerations are given so that a marketing director of the medical devices, etc., a domestic quality assurance administrator, and a safety control manager of medical devices can establish mutual coordination and cooperation among themselves and perform their services;
(vii)necessary considerations are given so that a marketing director of medical devices, etc. can fulfill the duties under Article 114-50;
(viii)opinions of a marketing director of medical devices, etc. provided in Article 114-50, item (ii) are respected.
(Documents Concerning Management Related to Establishment)
Article 114-55(1)A holder of marketing authorization for specially-designated medical devices requiring maintenance that need to be assembled when they are installed and require control over the assembly to prevent the occurrence of hazards in health and hygiene and that are designated by the Minister of Health, Labour and Welfare (hereinafter referred to as "installation controlled medical devices") must prepare documents indicating the assembly method per item of installation controlled medical devices and the confirmation methods for their quality (hereinafter referred to as the "installation control standard").
(2)When selling, providing, or leasing the controlled medical devices to sellers or leasers of medical devices (hereinafter referred to as "sellers, etc."), a holder of marketing authorization for installation controlled medical devices must issue an installation control standard to the sellers, etc. of the medical devices.
(3)When receiving a notice regarding the controlled medical devices under Article 170, paragraph (1) or Article 191, paragraph (6), a holder of marketing authorization for installation controlled medical devices must issue the installation control standard concerning the installation controlled medical devices to the person who has given such notice.
(4)In lieu of issuing the installation control standard under the preceding two paragraphs, a holder of marketing authorization for installation controlled medical devices may, pursuant to the provisions of paragraph (7), provide the matters that should be included in the installation control standard by a means that uses electronic data processing systems or other information communication technology and that is set forth in the following items (hereinafter referred to as "electronic or magnetic means" in this Article) with the consent of a person who is to receive the issuance of the installation control standard pursuant to these provisions (hereinafter referred to as "trustees, etc." in this Article).In this case, a holder of marketing authorization for installation controlled medical devices is deemed as having issued the installation control standard:
(i)the means set forth in (a) or (b) that use electronic data processing systems:
(a)the means of transmitting information through telecommunication lines that connects the computer used by a holder of marketing authorization for installation controlled medical devices and the computer used by the trustee, etc. and recording information in a file on the computer used by the receiver;
(b)the means of providing, through an electric line, information to be included in the installation control standard recorded in a file on the computer used by a holder of marketing authorization for installation controlled medical devices for the inspection of trustees, etc., and recording the information to be included in the installation control standard in a file on the computer used by the trustees, etc. (in the case of manifesting the consent of receiving the information by an electronic or magnetic means or requesting not to do so, the means of recording to the effect in a file on a computer used by the holder of marketing authorization for installation controlled medical devices);
(ii)a means that delivers records on a file prepared by using a magnetic disk, CD-ROM, or other equivalent media on which certain matters can be securely recorded.
(5)The means set forth in the preceding paragraph must be one that enables the trustees, etc. to prepare a document by outputting the record in the file.
(6)"Electronic data processing systems" prescribed in paragraph (4), item (i) means electronic data processing systems connecting the computer used by a holder of marketing authorization for installation controlled medical devices and the computer used by the trustees, etc. through telecommunication lines.
(7)When providing matters to be included in the installation control standard pursuant to the provisions of paragraph (4), a holder of marketing authorization for installation controlled medical devices must show the trustees, etc. the type and details of the following electronic or magnetic means and obtain a consent by documents or by electronic or magnetic means in advance:
(i)means provided in each of the items of paragraph (4) which are used by a holder of marketing authorization for installation controlled medical devices;
(ii)the means of recording in a file.
(8)The holder of marketing authorization for installation controlled medical devices who has obtained the consent under the preceding paragraph may not provide matters to be included in the installation control standard to the trustees, etc. by electronic or magnetic means when the holder of marketing authorization receives an offer from the trustees, etc. by documents or by electronic or magnetic means that the trustees, etc. will not receive data provided by electronic or magnetic means; provided, however, that this does not apply where the trustees, etc. consent pursuant to the provisions of the same paragraph again.
(9)When issuing the installation control standard pursuant to the provisions of paragraph (2) through the preceding paragraph, a holder of marketing authorization for installation controlled medical devices must prepare the record and maintain it for 15 years since the day of its preparation.
(Notification Concerning Import of Medical Devices or In-Vitro Diagnostics for Marketing)
Article 114-56(1)A holder of marketing authorization who plans to import medical devices or in-vitro diagnostics for marketing in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the holder of marketing authorization;
(ii)the type, number, and date of marketing license;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the registration number and date for a foreign manufacturer of medical devices received by the manufacturing facility in the preceding item.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 50 (the original and a duplicate).
(3)The holder of marketing authorization must submit a notification based on Form No. 51 (the original and a duplicate) to the Minister of Health, Labour and Welfare in cases where a matter described in a notification prescribed in the preceding paragraph has been changed.
(Notification Concerning Import of Medical Devices or In-Vitro Diagnostics for Manufacturing)
Article 114-57(1)A manufacturer who plans to import medical devices or in-vitro diagnostics for manufacture in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the manufacturer;
(ii)the registration number and date of registration for manufacturing;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the registration number and date for a foreign manufacturer of medical devices received by the manufacturing facility in the preceding item.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 52 (the original and a duplicate).
(3)The manufacturer must submit a notification based on Form No. 52-2 (the original and a duplicate) to the Minister of Health, Labour and Welfare in cases where a matter described in a notification prescribed in the preceding paragraph has been changed.
(Conformity of Methods to Control Manufacturing and Quality to Standards)
Article 114-58(1)Holders of marketing authorization for medical devices or in-vitro diagnostics (excluding designated holders of marketing authorization for foreign-manufactured medical devices, etc. and holders of marketing authorization designated pursuant to the provisions of Article 23-3, paragraph (1) of the Act (referred to as a "designated holders of marketing authorization for foreign-manufactured medical devices, etc." in the following paragraph)), persons with special approval for foreign-manufactured medical devices or foreign manufacturers of designated specially-controlled medical devices (referred to as a "holder of marketing authorization, etc." in the following paragraph) must conform methods to control manufacturing or quality of medical devices or in-vitro diagnostics to be marketed to the standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-2-5, paragraph (2), item (iv) of the Act.
(2)Designated holders of marketing authorization for foreign-manufactured medical devices, etc. that manufacture medical devices or in-vitro diagnostics and other manufacturers (excluding those manufacturing only medical devices or in-vitro diagnostics for export) or foreign manufacturers of medical devices registered pursuant to the provisions of Article 23-2-4, paragraph (1) of the Act (hereinafter referred to as "registered foreign manufacturers of medical devices") must cooperate in manufacturing and quality control conducted by holders of marketing authorization, etc. pertaining to the medical devices or in-vitro diagnostics in handling or manufacturing medical devices or in-vitro diagnostics.
(3)A manufacturer of medical devices or in-vitro diagnostics for export (limited to those provided in Article 73-2 of the Order) must conform methods to control manufacturing and quality at the manufacturing facility to the standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 80, paragraph (2) of the Act.
(Scope of Entrusting Post-Marketing Safety Control Activities)
Article 114-59Activities specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-2-15, paragraph (3) of the Act are as follows:
(i)collection of information on matters concerning the quality, efficacy, and safety of medical devices or in-vitro diagnostics and other information required for the appropriate use of medical devices, or in-vitro diagnostics (hereinafter referred to as "safety control information" in this chapter);
(ii)analysis of the safety control information;
(iii)implementation of necessary measures based on results of the investigation of the safety control information;
(iv)maintaining collected safety control information storage and other performance of business incidental to that set forth in the preceding three items.
(Scope of Further Entrusting Post-Marketing Safety Control Activities)
Article 114-60(1)A holder of marketing authorization for medical devices or in-vitro diagnostics may not let a person to whom the post-marketing safety control activities are entrusted (hereinafter referred to as the "trustee" in this chapter) further entrust the post-marketing safety control activities.
(2)Notwithstanding the provisions of the preceding paragraph, in entrusting the post-marketing safety control activities concerning medical device designated to be manufactured and sold integrally with drugs to a holder of marketing authorization for pharmaceuticals who supplies the drugs, a holder of marketing authorization for medical devices may have the trustee further entrust the post-marketing safety control activities.
(3)A holder of marketing authorization for medical devices may not let a person to whom the post-marketing safety control activities are further entrusted pursuant to the provisions of the preceding paragraph additionally entrust the post-marketing safety control activities.
(Measures to Entrust Post-Marketing Safety Control Activities for Specially-Controlled Medical Devices or Prescription In-Vitro Diagnostics)
Article 114-61(1)In case where a holder of marketing authorization entrusts activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of in-vitro diagnostics, which are specially-controlled medical devices or prescription pharmaceutical (hereinafter referred to as "prescription in-vitro diagnostics"), the trustee must meet the following requirements:
(i)a person is capable of conducting entrusted activities (hereinafter referred to as "entrusted safety assurance activities" in this article) appropriately and smoothly;
(ii)a supervisor conducting the activities who is capable of implementing the entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "entrusted safety control implementation supervisor" in this Article and Article 114-65) is assigned;
(iii)a copy of the procedure manuals concerning entrusted safety assurance activities prescribed in the following paragraph and other documents required for the entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities" in this Article) is provided at an office which implements the entrusted safety assurance activities.
(2)In entrusting activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization must prepare operating procedures for the post-marketing safety control activities concerning entrusted safety assurance activities to state the following procedures:
(i)the procedure for collecting the safety control information;
(ii)the procedure for planning safety assurance measures based on the review of the safety control information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the entrusted safety control implementation supervisor to the safety control manager of medical devices, etc.;
(v)the procedure for entrustment;
(vi)the procedure for maintaining records concerning entrusted safety assurance activities;
(vii)the procedure for mutual cooperation with a domestic quality assurance administrator and other a marketing person responsible for specially-controlled medical devices or prescription in-vitro diagnostics;
(viii)other procedures required to appropriately and smoothly implement entrusted safety assurance activities.
(3)In entrusting activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization must conclude an agreement with a trustee with a document listing the following matters and maintain the agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of entrusted safety assurance activities;
(ii)matters concerning an assignment of the entrusted safety control implementation supervisor and the scope of entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph (excluding item (v)) for entrusted safety assurance activities;
(iv)matters related to instructions of implementation of entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction prescribed in paragraph (6) and the confirmation prescribed in paragraph (7);
(vii)matters related to the provision of information prescribed in paragraph (8);
(viii)other necessary matters.
(4)In entrusting activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization must have a safety control manager of medical devices, etc. perform the following activities based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph:
(i)supervising entrusted safety assurance activities;
(ii)instructing the entrusted safety control implementation supervisor in the implementation of entrusted safety assurance activities in documents and maintaining copies of the documents (excluding cases where activities set forth in Article 114-59, item (i) are entrusted);
(iii)having the entrusted safety control implementation supervisor prepare records concerning entrusted safety assurance activities and report them in documents;
(iv)confirming whether a trustee implements entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to a holder of marketing authorization and a marketing director of the medical devices, etc. in documents.
(5)When entrusting activities set forth in Article 114-59, item (iv) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization must entrust them to a person who is able to implement the entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization must conclude an agreement with the trustee with a document listing the following matters and maintain the agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of entrusted safety assurance activities;
(ii)other necessary matters.
(6)A holder of marketing authorization must have the safety control manager of medical devices, etc. review the necessity of improvement of entrusted safety assurance activities, and if necessary, instruct the trustee to take required measures in documents and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(7)In cases of giving an instruction based on the provisions of the preceding paragraph, a holder of marketing authorization must confirm that the measures have been implemented and must maintain the record.
(8)A holder of marketing authorization must provide the trustee with information necessary to implement entrusted safety assurance activities.
(Measures to Entrust Post-Marketing Safety Control Activities for Controlled Medical Devices or In-Vitro Diagnostics Other Than Prescription In-Vitro Diagnostics)
Article 114-62When a holder of marketing authorization entrusts activities set forth in each of the items in Article 114-59 from among the post-marketing safety control activities of controlled medical devices or in-vitro diagnostics (excluding prescription in-vitro diagnostics), the provisions of the preceding Article (excluding paragraph (1), item (ii), paragraph (2), item (iv), and paragraph (3), item (ii)) apply mutatis mutandis.In this case, "entrusted safety control implementation supervisor" in paragraph (4), items (ii) and (iii) of the same Article is deemed to be replaced with "preliminarily designated person".
(Measures to Entrust Post-Marketing Safety Control Activities for General Medical Devices)
Article 114-63When a holder of marketing authorization entrusts activities set forth in each of the items in Article 114-59 from among the post-marketing safety control activities of general medical devices, the provisions of Article 114-61, paragraph (1), item (i), and paragraphs (3) through (8) of the same Article (excluding paragraph (3), items (ii) and (iii)) apply mutatis mutandis.In this case, the "following ... based on operating procedures, etc. for post-marketing safety control activities" in paragraph (3) of the same Article is deemed to be replaced with "following, " "operating procedures, etc. for post-marketing safety control activities and ... in the preceding paragraph" in paragraph (4) of the same Article with "the preceding paragraph", "the entrusted safety control implementation supervisor" in items (ii) and (iii) of the same paragraph with "preliminarily designated person", "following... based on operating procedures, etc. for post-marketing safety control activities " in paragraph (5) of the same Article with "following", and "the operating procedures, etc. for post-marketing safety control activities and... paragraph (3)" in paragraph (6) of the same Article with "paragraph (3)".
(Maintaining Records Concerning Entrusted Safety Assurance Activities)
Article 114-64(1)The period for maintaining documents to be maintained pursuant to the provisions of the preceding three Articles and other records is five years from the day when the record is no longer used; provided, however, that periods for maintaining the following records are the periods specified in each item:
(i)records concerning biological products (excluding those set forth in the following item and in item (iii)):10 years from the day when they are no longer used;
(ii)records concerning specified biological products:30 years from the day when they are no longer used;
(iii)records concerning specially-designated medical devices requiring maintenance and installation controlled medical devices (excluding those set forth in the preceding item):15 years from the day when they are no longer used.
(2)Notwithstanding the provisions of the preceding three Articles, a holder of marketing authorization may replace a person who must maintain records pursuant to the provisions of the preceding three Articles based on the operating procedures, etc. for the post-marketing safety control activities or predetermined documents with a person designated by a holder of marketing authorization to have the person maintain the records.
(Measures to Further Entrust Post-Marketing Safety Control Activities for Specially-Controlled Medical Devices or Prescription In-Vitro Diagnostics)
Article 114-65(1)When a trustee further entrusts activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, the further trustee of the activities must meet the following requirements:
(i)a person is capable of appropriately and smoothly conducting further-entrusted activities (hereinafter referred to as "further-entrusted safety assurance activities" in this article);
(ii)a supervisor conducting the activities who is capable of implementing the further-entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "further-entrusted safety control implementation supervisor" in this Article) is assigned;
(iii)a copy of the procedure manuals concerning further-entrusted safety assurance activities prescribed in the following paragraph and other documents required for the further-entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities" in this Article) is provided at an office which implements the further-entrusted safety assurance activities.
(2)When a trustee further entrusts activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization who is the entruster must have the trustee prepare operating procedures for the post-marketing safety control activities concerning further-entrusted safety assurance activities that state the following procedures:
(i)the procedure for collecting the safety control information;
(ii)the procedure for planning safety assurance measures based on the review of the safety control information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the further-entrusted safety control implementation supervisor to the entrusted safety control implementation supervisor;
(v)the procedure for further entrustment;
(vi)the procedure for maintaining records concerning further-entrusted safety assurance activities;
(vii)the procedure for trustees' mutual cooperation with a domestic quality assurance administrator and a person responsible for specially-controlled medical devices and prescription in-vitro diagnostics;
(viii)other procedures required to appropriately and smoothly implement further-entrusted safety assurance activities.
(3)When a trustee further entrusts activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with a further trustee with a document listing the following matters and maintain the agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)matters concerning an assignment of the further-entrusted safety control implementation supervisor and the scope of further-entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph (excluding item (v)) concerning further-entrusted safety assurance activities;
(iv)matters related to instructions for implementation of further-entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction prescribed in paragraph (6) and the confirmation prescribed in paragraph (7);
(vii)matters related to the provision of information prescribed in paragraph (8);
(viii)other necessary matters.
(4)When a trustee further entrusts activities set forth in Article 114-59, items (i) through (iii) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization who is the entruster must confirm that the trustee has the entrusted safety control implementation supervisor implement the following activities based on operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph:
(i)supervising further-entrusted safety assurance activities;
(ii)instructing the further-entrusted safety control implementation supervisor in the implementation of further-entrusted safety assurance activities in documents and maintaining copies of the documents (excluding cases where activities set forth in Article 114-59, item (i) are entrusted);
(iii)having the further-entrusted safety control implementation supervisor prepare records concerning further-entrusted safety assurance activities and report them in documents;
(iv)confirming whether a further trustee implements further-entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to the trustee and the trustee's marketing license holder's marketing director of the pharmaceuticals, quasi-pharmaceutical products or cosmetics in documents.
(5)When a trustee further entrusts activities set forth in Article 114-59, item (iv) from among the post-marketing safety control activities of specially-controlled medical devices or prescription in-vitro diagnostics, a holder of marketing authorization who is the entruster must have the trustee further entrust them to a person who is able to implement the further-entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with a further trustee with a document listing the following matters and maintain the agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)other necessary matters.
(6)A holder of marketing authorization who is the entruster must have the trustee instruct the entrusted safety control implementation supervisor to review the necessity of improvement of further-entrusted safety assurance activities, and if it is necessary, instruct the further trustee to take required measures in documents and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(7)When a trustee gives an instruction based on the provisions of the preceding paragraph, a holder of marketing authorization who is the entruster must have the trustee confirm if the measures have been implemented and maintain the record.
(8)A trustee must provide information necessary to implement further-entrusted safety assurance activities to a further trustee.
(Measures to Further Entrust Post-Marketing Safety Control Activities for In-Vitro Diagnostics Other Than Controlled Medical Devices or Prescription In-Vitro Diagnostics)
Article 114-66When a trustee further entrusts activities set forth in each of the items in Article 114-59 from among the post-marketing safety control activities of controlled medical devices or in-vitro diagnostics (excluding prescription in-vitro diagnostics), the provisions of the preceding Article (excluding paragraph (1), item (ii), paragraph (2), item (iv), and paragraph (3), item (ii)) apply mutatis mutandis.In this case, "entrusted safety control implementation supervisor" in paragraph (4) of the same Article is deemed to be replaced with "person preliminarily designated by a trustee" and "further-entrusted safety control implementation supervisor" in items (ii) and (iii) of the same paragraph with "person preliminarily designated by a further trustee".
(Measures to Further Entrust Post-Marketing Safety Control Activities for General Medical Devices)
Article 114-67When a trustee further entrusts activities set forth in each of the items in Article 114-59 from among the post-marketing safety control activities of general medical devices, the provisions of Article 114-65, paragraph (1), item (i) and paragraphs (3) through (8) of the same Article (excluding paragraph (3), items (ii) and (iii)) apply mutatis mutandis.In this case, "following ... based on operating procedures, etc. for post-marketing safety control activities" in paragraph (3) of the same Article is deemed to be replaced with "following", "operating procedures, etc. for post-marketing safety control activities and ... in the preceding paragraph" in paragraph (4) of the same Article with "the preceding paragraph", "the further-entrusted safety control implementation supervisor" in items (ii) and (iii) of the same paragraph with "a person preliminarily designated by further trustee", "the operating procedures, etc. for post-marketing safety control activities and...in paragraph (3)" in paragraph (6) of the same Article with "paragraph (3)".
(Maintaining Records Concerning Further-Entrusted Safety Control Activities)
Article 114-68The provisions of Article 114-64 apply mutatis mutandis to the period for maintaining documents and other records to be maintained pursuant to the provisions of the preceding three Articles.In this case, "holder of marketing authorization" in paragraph (2) of the same Article is deemed to be replaced with "trustee".
(Notification of Changes of Marketing Directors of Medical Devices in Marketing)
Article 114-69(1)Matters whose changes must be notified pursuant to the provisions of Article 23-2-16, paragraph (1) of the Act are as follows:
(i)the name and address of the holder of marketing authorization;
(ii)the name and location of the office with major function;
(iii)in cases where the holder of marketing authorization is a corporation, the name of the officer who is engaged in the operation;
(iv)the name and address of the marketing director of medical devices;
(v)in cases where the holder of marketing authorization receives another type of license for marketing or abolishes the business concerning the license, the type of the license and the license number.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 6.
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the notifications at the time of application and other acts, if the notification has a supplementary note to that effect:
(i)a notification concerning names of holders of marketing authorization set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of the holder of marketing authorization (a certificate of registered information if the holder of marketing authorization is a corporation);
(ii)a notification concerning an officer set forth in paragraph (1), item (iii):a doctor's written diagnosis with regard to mental impairment of the new officer or whether or not the officer is addicted to narcotics, cannabis, opium, or stimulants;
(iii)a notification concerning matters set forth in paragraph (1), item (iv) (excluding a case where a new marketing director of the medical devices, etc. is a holder of marketing authorization):a copy of an employment agreement or other documents proving an employment relationship between the holder of marketing authorization and the new marketing director of medical devices, etc.
(4)The provisions of Article 16, paragraph (4) apply mutatis mutandis to a notification prescribed in paragraph (1).In this case, "prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward)" in the same paragraph is deemed to be replaced with "prefectural governor".
(Notification of Changes of Technical Supervisors of Medical Devices in Manufacturing)
Article 114-70(1)Matters whose changes must be notified pursuant to the provisions of Article 23-2-16, paragraph (2) of the Act are as follows:
(i)the name and address of the manufacturer or the foreign manufacturer of medical devices (hereinafter referred to as "manufacturers, etc." in this Article), or the technical supervisor of medical devices or the manufacturing supervisor of in-vitro diagnostics (in case of a foreign manufacturer of medical devices, the person responsible for the manufacturing facility) (referred to as the "technical supervisor of medical devices, etc." in paragraph (3), item (ii));
(ii)in cases where the manufacturer, etc. is a corporation, the name of the officer who is engaged in the operation;
(iii)the name of the manufacturing facility;
(iv)in cases where the manufacturer, etc. receives another license, accreditation, or registration for manufacturing, or abolishes the manufacturing facility, the criteria and license number for the license, the criteria and accreditation number for the accreditation or the registration number for the registration.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 6.
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare or a prefectural governor who is in charge of receiving the notifications at the time of application and other acts, if the notification has a supplementary note to that effect:
(i)a notification concerning names of manufacturer, etc. set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of the manufacturer etc. (certificate of registered information if the manufacturer etc. is a corporation);
(ii)a notification concerning names of technical supervisors of medical devices, etc. set forth in paragraph (1), item (i) (excluding cases where a new technical supervisor of medical devices, etc. is a manufacturer, etc.):a copy of an employment agreement or other documents proving an employment relationship between a manufacturer, etc. and a new technical supervisor of medical devices, etc.;
(iii)a notification concerning an officer set forth in paragraph (1), item (ii):a document which shows a new officer does not fall under Article 5, item (iii), (e) and (f) of the Act.
(Maintaining Data)
Article 114-71A person receiving approval for medical devices must preserve data set forth in each of the following items for periods set forth in each of the same items; provided, however, that this does not apply to data in cases where it is recognized that the nature of the data makes it extremely difficult to preserve:
(i)data which the data submitted at the time of application for approval prescribed in Article 23-2-5, paragraph (1) or (11) of the Act is based on:five years from the date when approval is obtained; provided, however, that in case of data concerning medical devices or in-vitro diagnostics that needs evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act (limited to those whose period from the day when an approval is obtained to the day when an evaluation of the results of usage is completed is more than five years), the period until the completion of the evaluation of the results of usage;
(ii)data which the data submitted at the time of application for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act (excluding data set forth in the preceding item) is based on:five years from the date when the evaluation of the results of usage is completed.
(Application for Approval of Marketing Medical Devices Manufactured in Foreign Countries)
Article 114-72(1)An application for approval of marketing medical devices or in-vitro diagnostics prescribed in Article 23-2-17, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 63-22 (the original copy and two duplicates) to the Minister of Health, Labour and Welfare.
(2)The provisions of Articles 114-19 and 114-20 apply mutatis mutandis to the data that should be attached to a written application prescribed in the preceding paragraph.
(3)The following documents must be attached to the written application prescribed in paragraph (1); provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)in cases where an applicant is a corporation, a certificate proving the same;
(ii)documents that clearly indicate whether an applicant (including the officer engaged in the business operation if the applicant is a corporation) is a person provided in Article 23-2-17, paragraph (2) of the Act;
(iii)a document proving a designated holder of marketing authorization for foreign-manufactured medical devices has been designated;
(iv)a copy of license certificate for marketing obtained by the designated holder of marketing authorization for foreign-manufactured medical devices;
(v)a document proving that items to be marketed by an applicant are medical devices or in-vitro diagnostics set forth in Article 23-2-8, paragraph (1), item (ii) of the Act and other necessary documents when applying for an approval prescribed in Article 23-2-17, paragraph (1) of the Act pursuant to the provisions of Article 23-2-8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-20 of the Act.
(Matters to Be Included in Registry of Approval for Marketing Medical Devices Manufactured in Foreign Countries)
Article 114-73Matters to be included in the registry of approval prescribed in Article 23-2-17, paragraph (1) of the Act and Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) of the Act provided in Article 37-19 of the Order are to be the following matters beyond what is set forth in each of the items of Article 114-27 (excluding item (iii)):
(i)the name and address of a designated holder of marketing authorization for foreign-manufactured medical devices;
(ii)the type and license number for the marketing license obtained by the designated holder of marketing authorization for foreign-manufactured medical devices.
(Matters to Be Observed by Designated Holders of Marketing Authorization for Foreign-Manufactured Medical Devices)
Article 114-74Matters to be observed by a designated holder of marketing authorization for foreign-manufactured medical devices are as follows beyond what is set forth in each of the items of Article 114-54:
(i)matters related to activities as a designated holder of marketing authorization for foreign-manufactured medical devices are recorded and maintained for five years from the date on which the final description therein was made;
(ii)documents set forth in the following (a) to (d) are maintained for five years from the date when they are no longer used:
(a)documents showing matters for which a person with special approval for foreign-manufactured medical devices has obtained the approval;
(b)copies of data submitted at the time of application for approval prescribed in Article 23-2-17, paragraph (1) of the Act and Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) of the Act by a person with special approval for foreign-manufactured medical devices;
(c)copies of data submitted at the time of application for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-19 of the Act by a person with special approval for foreign-manufactured medical devices;
(d)documents showing matters reported by a person with special approval for foreign-manufactured medical devices to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 23-2-9, paragraph (6) of the Act or Article 23-2-10, paragraph (2) of the Act as applied mutatis mutandis pursuant to Article 23-2-19 of the Act, periodic reporting of infectious diseases concerning biological products reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 68-24, paragraph (1) or Article 68-25, paragraph (3) of the Act, and matters reported to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 75-2-2, paragraph (1), item (ii) of the Act;
(iii)the data on which matters concerning the occurrence of failures, diseases, disability, or death suspected to be influenced by failures, or infectious diseases suspected to be caused by the use are based (hereinafter referred to as "failures, etc.") reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 68-10, paragraph (1) of the Act or Article 68-13, paragraph (3) of the Act is preserved for five years from the day when it is no longer used; provided, however, that this does not apply to data which is found extremely difficult to be preserved due to the nature of the data.
(Notification of Changes Concerning Designated Holders of Marketing Authorization for Foreign-Manufactured Medical Devices)
Article 114-75(1)Matters whose changes must be notified pursuant to the provisions of Article 23-2-18 of the Act are as follows:
(i)the name or address of a designated holder of marketing authorization for foreign-manufactured medical devices;
(ii)the type and license number for the marketing license obtained by the designated holder of marketing authorization for foreign-manufactured medical devices.
(2)A notification of changes of designated holders of marketing authorization for foreign-manufactured medical devices under Article 23-2-18 of the Act and a notification prescribed in the preceding paragraph are to be made by submitting a notification based on Form No. 54 per item (the original and two duplicates).
(3)A copy of the license certificate for marketing obtained by the designated holders of marketing authorization for foreign-manufactured medical devices must be attached to the notifications prescribed in the preceding paragraph; provided, however, that this does not apply to cases where the copy of the license certificate is submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the notification has a supplementary note to that effect.
(Provision of Information)
Article 114-76(1)A person with special approval for foreign-manufactured medical devices must provide the following information to a designated holder of marketing authorization for foreign-manufactured medical devices:
(i)changed matters and reasons for the change in case of matters approved for the item pursuant to the provisions of Article 23-2-17, paragraph (1) of the Act and in cases where those matters change pursuant to the provisions of Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5);
(ii)copies of the data submitted at the time of application for approval prescribed in Article 23-2-17, paragraph (1) of the Act and Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) of the Act, and copies of the data submitted at the time of application for evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-19 of the Act;
(iii)matters reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 23-2-9, paragraph (6) or Article 23-2-10, paragraph (2) of the Act as applied mutatis mutandis pursuant to Article 23-2-19 of the Act;
(iv)information required to indicate matters provided in Articles 50, 63, or 68-17 of the Act and if the information has been changed, a reason for the change;
(v)information on matters provided in Articles 52, 63-2, or 68-18 of the Act and if the information has been changed, a reason for the change;
(vi)matters reported to the Minister of Health, Labour and Welfare pursuant to provisions of Article 69, paragraph (1) or (4) or Article 75-2-2, paragraph (1), item (ii) of the Act;
(vii)beyond what is set forth in each of the preceding items, information necessary for designated holders of marketing authorization for foreign-manufactured medical devices to do business operations.
(2)When changing a designated holder of marketing authorization for foreign-manufactured medical devices, a person with special approval for foreign-manufactured medical devices must have the designated holder of marketing authorization for foreign-manufactured medical devices before the change carry over records provided in Article 114-74, item (i), documents provided in item (ii) of the same Article, data provided in item (iii) of the same Article, information provided in the preceding paragraph, data concerning manufacturing and quality control operations, and data concerning post-marketing safety control activities to the designated holder of marketing authorization for foreign-manufactured medical devices after the change.
(3)In cases prescribed in the preceding paragraph, if the designated holder of marketing authorization for foreign-manufactured medical devices before the change is a person approved for designated medical devices provided in Article 68-5, paragraph (1) of the Act or a person approved for biological products provided in Article 68-22, paragraph (1) of the Act, the designated holder of marketing authorization for foreign-manufactured medical devices must deliver records concerning the designated medical devices or biological products and data relating to the records to the designated holder of marketing authorization for foreign-manufactured medical devices after the change.
(Books Concerning Business Operation of Persons with Special Approval for Foreign-Manufactured Medical Devices)
Article 114-77A person with special approval for foreign-manufactured medical devices must prepare books, provide information to a designated holder of marketing authorization for foreign-manufactured medical devices, record matters concerning other activities as a person with special approval for foreign-manufactured medical devices based on a special approval before the change and maintain the books for three years from the date on which the final description therein was made.
(Notification of Changes Concerning Persons with Special Approval for Foreign-Manufactured Medical Devices)
Article 114-78(1)Matters specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 37-34, paragraph (1) of the Order are as follows:
(i)the name or address of a person with special approval for foreign-manufactured medical devices;
(ii)in cases where a person with special approval for foreign-manufactured medical devices is a corporation, the name of the officer who is engaged in the operation;
(iii)a manufacturing facility which manufactures items or its name.
(2)Notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 54 (the original and two duplicates).
(3)In cases where a notification prescribed in paragraph (1) is related to matters set forth in item (i) of the same paragraph, documents proving this, and if it is related to matters set forth in item (ii) of the same paragraph, documents clearly indicating whether an officer after change is a person provided in Article 23-2-17, paragraph (2) of the Act, must be attached to the notification prescribed in the preceding paragraph.
(Procedures for Application for Persons with Special Approval for Foreign-Manufactured Medical Devices)
Article 114-79Procedures for application, notification, report, submission, and others from a person who intends to receive an approval prescribed in Article 23-2-17, paragraph (1) of the Act or from a person with special approval for foreign-manufactured medical devices to the Minister of Health, Labour and Welfare are to be carried out by a designated holder of marketing authorization for foreign-manufactured medical devices.
(Maintaining Data of Persons with Special Approval for Foreign-Manufactured Medical Devices)
Article 114-80(1)The provisions of Article 114-71 apply mutatis mutandis to a person with special approval for foreign-manufactured medical devices.
(2)A person with special approval for foreign-manufactured medical devices must maintain data on which matters reported to the Minister of Health, Labour and Welfare or the PMDA pursuant to the provisions of Article 75-2-2, paragraph (1), item (ii) of the Act are based for five years from the day when they are reported to the Minister of Health, Labour and Welfare.
(3)When maintaining the data prescribed in the preceding paragraph, the provisions of the proviso of the parts other than those listed in each of the items in Article 114-71 apply mutatis mutandis.
(Application, Mutatis Mutandis)
Article 114-81The provisions of Article 114-18, Articles 114-20 through 114-26, Article 114-28 and Articles 114-32 through 114-46 apply mutatis mutandis to the approval prescribed in Article 23-2-17, paragraph (1) of the Act or Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) of the Act.In this case, "Form No. 63-9" in Article 114-24, paragraph (1) is deemed to be replaced with "Form No. 63-23", "Form No. 63-10" in Article 114-26, paragraph (1) with "Form No. 63-24", "Form No. 63-11" in Article 114-28, paragraph (1) with "Form No. 63-25", "Form No. 63-13" in Article 114-33, paragraph (2) with "Form No. 63-26", "Form No. 63-14" in Article 114-34, paragraph (1) with "Form No. 63-27", "Form No. 63-15" in Article 114-37, paragraph (3) with "Form No. 63-28", "Form No. 63-12" in Article 114-38, paragraph (2) with "Form No. 63-29", "Form No. 63-17" in Article 114-39 with "Form No. 63-30", "Form No. 63-18" in Article 114-44, paragraph (2) with "Form No. 63-31", and "Form No. 63-20" in Article 114-46, paragraph (2) with "Form No. 63-32".
Article 114-82The provisions of Article 15-9 apply mutatis mutandis to holders of marketing authorization for or manufacturers of medical devices or in-vitro diagnostic pharmaceuticals.In this case, "as a registered sales clerk" in paragraph (1) of the same Article is deemed to be replaced with "prescribed by Article 114-49, paragraph (1), item (ii) or (iii), or paragraph (2), item (ii) or Article 114-53, paragraph (1), item (ii) or (iii), or paragraph (2), item (ii)".
Article 114-83(1)The provisions of Article 173, paragraph (1) apply mutatis mutandis to holders of marketing authorization for or manufacturers of specially-controlled medical devices or specially-designated medical devices requiring maintenance (hereinafter referred to as "specially-controlled medical devices, etc.").
(2)The provisions of Article 14, paragraphs (1) and (3) apply mutatis mutandis to holders of marketing authorization for or manufacturers of in-vitro diagnostics.In this case, "for three years... for two years since the day on which the final description is made in documents prescribed in the preceding paragraph" is deemed to be replaced with "three years".
Article 114-84The provisions of Article 15-10 apply mutatis mutandis to holders of marketing authorization for or manufacturers of in-vitro diagnostic pharmaceuticals.In this case, "a pharmacist or a registered sales clerk" is deemed to be replaced with "a pharmacist".
Article 114-85(1)The provisions of Articles 3 and 18 apply mutatis mutandis to holders of marketing authorization for medical devices or in-vitro diagnostics.
(2)The provisions of Articles 3 and 18 apply mutatis mutandis to manufacturers of medical devices or in-vitro diagnostics.In this case, "license certificate" in Article 3 is deemed to be replaced with "registration certificate".
(3)The provisions of Article 18 apply mutatis mutandis to registered foreign manufacturers of medical devices.
Section 2 Registered Certification Bodies
(Application for Certification)
Article 115(1)An application for certification of designated specially-controlled medical devices, etc. prescribed in Article 23-2-23, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 64 (the original and a duplicate) to an registered certification body (meaning the registered certification body provided in the same paragraph; the same applies hereinafter).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph:
(i)data concerning compliance with the standards specified by the Minister of Health, Labour and Welfare prescribed in Article 23-2-23, paragraph (1) of the Act;
(ii)data concerning compliance with the standard if the standard is established pursuant to the provisions of Article 41, paragraph (3) of the Act or Article 42, paragraph (1) or (2) of the Act.
(Procedures for Certification)
Article 116The procedure for the certification of conformity provided in Article 23-4, paragraph (1) of the Act (hereinafter referred to as the "certification of conformity") must be carried out by means that conform to the standards concerning the body certifying products and the standards concerning the body examining measures for manufacturing control and quality control, both of which are specified by the International Organization for Standardization (ISO) and the International Electro technical Commission (IEC).
(Matters to Be Included in Registry of Certification)
Article 117(1)Matters to be included in the registry concerning the certification of conformity provided in Article 42 of the Order are as follows:
(i)the certification number and date;
(ii)the name and address of the person who receives the certification of conformity;
(iii)the type and license number for the marketing license of a person who receives the certification of conformity (excluding foreign manufacturers of designated specially-controlled medical devices);
(iv)the name of the manufacturing facility of the item;
(v)the registration number for the manufacturer or the foreign manufacturer of medical devices accepted by a manufacturing facility of the item;
(vi)the name of the item;
(vii)the shape, structure, and principle of the item;
(viii)components concerning the reaction system of the item (limited to In-vitro Diagnostics);
(ix)the purpose of use or effect of the item;
(x)the usage of the item.
(2)Matters to be included in the registry concerning the certification of conformity provided in Article 42 of the Order concerning foreign manufacturers of designated specially-controlled medical devices are as follows, beyond what is set forth in paragraph (1):
(i)the name and address of a holder of marketing authorization designated pursuant to the provisions of Article 23-3, paragraph (1) of the Act (hereinafter referred to as an "appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices");
(ii)the type and license number for the marketing license obtained by the appointed holders of marketing authorization for foreign-manufactured designated specially-controlled medical devices, etc.
(3)A registered certification body can prepare all or part of the registries prescribed in the preceding two paragraphs by using a magnetic disk.
(Applying Mutatis Mutandis Concerning Certification of Conformity)
Article 118(1)The provisions of Article 114-24, paragraph (1), Article 114-25, Article 114-26 (excluding paragraph (3)), Article 114-28 (excluding paragraph (3)), Articles 114-29 through 114-31, Articles 114-33 (excluding paragraph (3)) through 114-36, and Article 114-71 (excluding item (ii)) apply mutatis mutandis to the certification prescribed in Article 23-2-23, paragraph (1) of the Act.
(2)In cases prescribed in the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms and phrases set forth in the middle column of the same table are deemed to be replaced with those set forth in the right-hand column of that table.
Article 114-24, paragraph (1)
Article 23-2-5, paragraph (11)
Article 23-2-23, paragraph (6)
approval
Certification
Form No. 63-9
Form No. 65
written application... (the original and two duplicates) to the Minister of Health, Labour and Welfare
written application... (the original and a duplicate) to a registered certification body
Article 114-25
Article 23-2-5, paragraph (11)
Article 23-2-23, paragraph (6)
approval
certification
Article 114-26, paragraph (1)
Article 23-2-5, paragraph (12)
Article 23-2-23, paragraph (7)
Form No. 63-10
Form No. 66
Submission submitting ... to the Minister of Health, Labour and Welfare
Submission submitting
Article 114-26, paragraph (2)
Article 23-2-5, paragraph (11)
Article 23-2-23, paragraph (6)
Article 114-28, paragraph (1)
Article 23-2-5, paragraph (6) or (8) (These provisions in paragraph (11) of the same Article
Article 23-2-23, paragraph (3) or (5) (These provisions in paragraph (6) of the same Article
Form No. 63-11
Form No. 67
Submission filing ... to the Minister of Health, Labour and Welfare
Submission filing
Article 114-29
A person conducting a compliance investigation of medical devices, etc. (meaning a person conducting a compliance investigation of medical devices, etc. prescribed by Article 37-23 of the Order)
A registered certification body (the one provided in Article 23-2-23, paragraph (1) of the Act; the same applies hereinafter)
of the same Article
of Article 40-2 of the Order
person granting licenses for marketing Medical Devices, etc. (those provided in the same Article)
person providing license for marketing the item
Form No. 63-12
Form No. 68
Article 114-30
Article 37-24
Article 40-3
Approval
Certification
Article 114-33, paragraph (2)
Article 114-33, paragraph (2) as applied mutatis mutandis pursuant to Article 118, paragraph (1)
Article 114-34, paragraph (2)
Article 114-34, paragraph (2) as applied mutatis mutandis pursuant to Article 118, paragraph (1)
Article 114-31
Article 37-25, paragraph (1)
Article 40-4, paragraph (1)
Parts other than listed in each of the items in Article 114-33, paragraph (1)
the Minister of Health, Labour and Welfare
Registered Certification Body
Article 23-2-5, paragraph (8)
Article 23-2-23, paragraph (5)
Article 114-33, paragraph (1), item (i)
Article 23-2-5, paragraph (1) or (11)
Article 23-2-23, paragraph (1) or (6)
approval
certification
Article 114-33, paragraph (1), items (ii) through (iv)
approval
certification
Article 114-33, paragraph (1), item (v)
Cases where Medical Devices or In-Vitro diagnostics pertaining to an approval
Cases where Medical Devices or In-vitro Diagnostics related to certification
approval
certification
Article 114-33, paragraph (2)
the Minister of Health, Labour and Welfare
a registered certification body
Form No. 63-13
Form No. 68-2
Article 114-34, paragraph (1)
Article 23-2-6, paragraph (1)
Article 23-2-24, paragraph (1)
Form No. 63-14
Form No. 68-3
Article 114-34, paragraph (2)
Article 23-2-5, paragraph (6) (paragraph (11) of the same Article)
Article 23-2-23, paragraph (3) (paragraph (6) of the same Article)
Article 114-35
Article 37-26, paragraph (2)
Article 40-5, paragraph (2)
Article 114-36
Article 37-27, paragraph (2)
Article 40-6, paragraph (2)
Parts other than listed in each of the items in Article 114-71
person receiving approval for medical devices
persons certified for Medical Devices, etc.
Article 114-71, item (i)
Article 23-2-5, paragraph (1) or (11)
Article 23-2-23, paragraph (1) or (6)
approval
certification
five years... provided, however, in case of data concerning Medical Devices or In-in-vitro diagnostics that needs an evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act (limited to those whose period from the day when an approval is obtained to the day when an evaluation of the results of usage is completed is more than fiveyears), the period until the completion of the evaluation on of the results of usage
five years
(3)Beyond what is provided in paragraph (1), the provisions of Article 114-74 (excluding item (ii), (c) and (d)), Article 114-75, Article 114-76 (excluding paragraph (1), item (iii)), Article 114-77 and Article 114-80 (excluding paragraph (1)) apply mutatis mutandis to foreign manufacturers of designated specially-controlled medical devices.
(4)In cases prescribed in the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms and phrases set forth in the middle column of the same table are deemed to be replaced with those set forth in the right-hand column of that table.
Article 114-74
designated holder of marketing authorization for foreign-manufactured medical devices
holders of marketing authorization designated pursuant to the provisions of Article 23-3, paragraph (1) of the Act(hereinafter referred to as the "appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices ")
person with special approval for foreign-manufactured medical devices
foreign manufacturer of designated specially-controlled medical device, etc. obtaining the certification in Article 23-2-23 of the Act (hereinafter referred to as " persons with special certification for foreign-manufactured medical devices")
approval
certification
Article 23-2-17, paragraph (1) and Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraphs (5)
Article 23-2-23, paragraph (1) or (6)
Article 114-75, paragraph (1)
Article 23-2-18
Article 23-3, paragraph (2)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-75, paragraph (2)
Article 23-2-18
Article 23-3, paragraph (2)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Form No. 54
Form No. 68-4
the original and two duplicates
the original and a duplicate
Article 114-75, paragraph (3)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
the Minister of Health, Labour and Welfare
Registered Certification Body
Parts other than listed in each of the items in Article 114-76
person with special approval for foreign-manufactured medical devices
persons with special certification for foreign-manufactured medical devices
designated holder of marketing authorization for foreign-manufactured medical devices.
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-76, paragraph (1), item (i)
Article 23-2-17, paragraph (1)
Article 23-2-23, paragraph (1)
approval
certification
Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to paragraph (5) of the same Article
paragraph (6) of the same Article
Article 114-76, paragraph (1), item (ii)
Copies of data submitted in making an application prescribed in Article 23-2-17, paragraph (1), and Article 23-2-5, paragraph (11) of the Act as applied mutatis mutandis pursuant to Article 23-2-17, paragraph (5) and evaluation of the results of usage prescribed in Article 23-2-9, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-2-19 of the Act
Certifications prescribed in Article 23-2-23, paragraphs (1) and (6)
Article 114-76, paragraph (1), item (vii)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-76, paragraph (2)
person with special approval for foreign-manufactured medical devices
persons with special certification for foreign-manufactured medical devices)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-74, item (i)
Article 114-74, item (i) as applied mutatis mutandis pursuant to Article 118, paragraph (3)
Article 114-76, paragraph (3)
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-77
person with special approval for foreign-manufactured medical devices
persons with special certification for foreign-manufactured medical devices
designated holder of marketing authorization for foreign-manufactured medical devices
appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices
Article 114-80, paragraph (2)
person with special approval for foreign-manufactured medical devices
persons with special certification for foreign-manufactured medical devices)
Article 114-80, paragraph (3)
proviso of parts other than listed in each of the items in Article 114-71
proviso of the part other than each of the items in Article 114-71 as applied mutatis mutandis pursuant to Article 118, paragraph (1)
(Notification of Succession)
Article 118-2(1)The data and the information specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-3-2, paragraph (1) of the Act is as follows:
(i)data submitted at the time of application for registration prescribed in Article 23-2-3, paragraph (1) of the Act or Article 23-2-4, paragraph (1) of the Act;
(ii)data submitted at the time of application for certification prescribed in Article 23-2-23, paragraph (1) of the Act and application for certification of partial change to the matters to be certified prescribed in paragraph (6) of the same Article, and data which the submitted data is based on;
(iii)records relating to biological products under Article 68-22, paragraph (1) of the Act and data related to those records;
(iv)the data and the information concerning manufacturing or quality control operations;
(v)the data and the information concerning post-marketing safety control activities;
(vi)other documents and information concerning quality, efficacy, and safety.
(2)Notification under Article 23-3-2, paragraph (3) of the Act is to be given by submitting a notification based on Form No. 68-5 (the original and a duplicate) to a registered certification body.
(3)A document showing an applicant succeeds to the status of a person certified for medical devices must be attached to the notification prescribed in the preceding paragraph.
(Report by Registered Certification Bodies)
Article 119(1)The report provided in Article 23-5, paragraph (1) of the Act is to include the following matters and is to be submitted every month to the Minister of Health, Labour and Welfare by the last day of the following month:
(i)the name and address of a holder of marketing authorization or a foreign manufacturer of designated specially-controlled medical devices related to the certification of conformity granted in the month or the notification under Article 23-2-23, paragraph (7) of the Act received in the month (hereinafter referred to as "certifications, etc." in this paragraph);
(ii)in the case of foreign manufacturers of designated specially-controlled medical devices, the name and address of the appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices;
(iii)the license number for the marketing license obtained by the holder of marketing authorization or appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices;
(iv)the name and location of the manufacturing facility of the item concerning the certification, etc. and the overview of the manufacturing process;
(v)the purpose of use or effect of the item concerning the certification, etc.;
(vi)the name of item concerning the certification, etc. and its certification number;
(vii)the certification date or the date when the day of receiving a notification;
(viii)the date of the investigation under Article 23-2-23, paragraphs (3) and (5) of the Act and the investigation results and the overview, and copies of a conformity certificate related to the investigation under paragraph (3) of the same Article and a certificate of additional investigation results related to the investigation under paragraph (5) of the same Article at the time of application for the certification of conformity;
(ix)a date of the audit based on the standards provided in Article 128 concerning certifications, etc. and the overview of the audit results;
(x)in the case of the change concerning certifications, etc. (including minor changes), or the cancellation of the certification of conformity, the fact thereof;
(xi)names and addresses of the person certified for medical devices pertaining to a notification of succession under Article 23-3-2, paragraph (3) of the Act received in the month and the person who has succeeded to the status, and the name of the item and its certification number.
(2)Beyond what is set forth in the preceding paragraph, in cases of cancelling a certification pursuant to the provisions of Article 23-4, paragraph (1) or (2) of the Act, notice of matters set forth in the following items concerning the certification must be given to a person granting marketing licenses via the Minister of Health, Labour and Welfare within seven days:
(i)name and address of a holder of marketing authorization or a foreign manufacturer of designated specially-controlled medical devices whose certification is canceled pursuant to the provisions of Article 23-4, paragraph (1) or (2) of the Act;
(ii)in the case of foreign manufacturers of designated specially-controlled medical devices, the name and address of the appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices;
(iii)the license number for the marketing license obtained by the holder of marketing authorization or an appointed holder of marketing authorization for foreign-manufactured designated specially-controlled medical devices;
(iv)the purpose of use or effect of the item concerning the cancellation of certification;
(v)the name of item concerning the cancellation of a certification and its certification number;
(vi)the certification date;
(vii)the date when the certification is canceled;
(viii)the reason why the certification is canceled.
(3)In applying the provisions of the preceding two paragraphs when the Minister of Health, Labour and Welfare decides to have the PMDA undergo an examination pursuant to the provisions of Article 23-2-7, paragraph (1) of the Act, the term "Minister of Health, Labour and Welfare" in the same paragraph is deemed to be replaced with "PMDA".
(Notice Concerning Acceptance of Report by the PMDA)
Article 120a notification of acceptance of report to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of the second sentence of Article 23-5, paragraph (2) of the Act is to be given by using a notification based on Form No. 69.
(Application for Registration)
Article 121(1)An application prescribed in Article 23-6, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 70 to the Minister of Health, Labour and Welfare.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph:
(i)articles of incorporation and certificate of registered information;
(ii)the settlement, inventory of property, balance sheet, profit and loss statement of the business year immediately preceding the year including the application date;
(iii)the business report of the business year immediately preceding the year including the application date and the business summary report and the budget statements (which classify matters concerning examination for the certification of conformity (hereinafter referred to as the "examination for certification of conformity") and matters concerning other activities) for the year including the application date;
(iv)documents including the following matters:
(a)the name and resume of an officer (in cases of a membership company (meaning a membership company provided in Article 575, paragraph (1) of the Companies Act (Act No. 86 of 2005); the same applies hereinafter), a partner who executes business) or a business operator;
(b)the shareholder composition at the end of the business year immediately preceding the year including the application date;
(c)past records of the examination for certification of conformity;
(d)names and resumes of examiner of the examination for certification of conformity (hereinafter referred to as "examiner" in this chapter) and the scope of their activities;
(e)in the case of judges perform activities other than the examinations for certification of conformity, the type of activities and the overview;
(v)documents which show the applicant satisfies requirements set forth in any of the items of Article 23-7, paragraph (1) of the Act;
(vi)documents which show the applicant does not fall under any of the items of Article 23-7, paragraph (2) of the Act;
(vii)documents showing other matters that will be of reference.
(Issuance of Registration Certificate by Registered Certification Bodies)
Article 122(1)The Minister of Health, Labour and Welfare must issue a registration certificate to an applicant for registration when a registration is made prescribed in Article 23-6, paragraph (1) of the Act. The same applies when a registration is renewed pursuant to the provisions of Article 23-6, paragraph (3) of the Act.
(2)The registration certificate prescribed in the preceding paragraph is to be based on Form No. 71.
(Updated Issuance of Registration Certificate by Registered Certification Bodies)
Article 123(1)A registered certification body may apply for the updated issuance of a registration certificate when any matter included in the registration certificate is changed.
(2)When filing the application prescribed in the preceding paragraph, the applicant must submit a written application based on Form No. 3 with a registration certificate to the Minister of Health, Labour and Welfare.
(Reissuance of Registration Certificate by Registered Certification Bodies)
Article 124(1)A registered certification body may apply for the reissuance of their registration certificate when they have torn, dirtied or lost the registration certificate.
(2)When filing the application prescribed in the preceding paragraph, the applicant must submit a written application based on Form No. 4 to the Minister of Health, Labour and Welfare.In this case, the applicant who tore or dirtied the registration certificate must attach the registration certificate to the written application.
(3)When finding the lost registration certificate after having the registration certificate reissued, the registered certification body must immediately return the found certificate to the Minister of Health, Labour and Welfare.
(Return of Registration Certificate by Registered Certification Bodies)
Article 125If a registered certification body has accepted a disposition for revocation of its registration under Article 23-16, paragraph (1) of the Act, or has abolished its business, the body must immediately return the registration certificate to the Minister of Health, Labour and Welfare.
(Notification of Results of Investigation to Registered Certification Bodies by the PMDA)
Article 125-2The PMDA must notify the Minister of Health, Labour and Welfare of the results when it undergoes an investigation under Article 23-6, paragraph (2) of the Act.
(Application for Renewal of Registration)
Article 126(1)An application for renewal of a registration under Article 23-6, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 72 to the Minister of Health, Labour and Welfare.
(2)The registration certificate concerning the application must be attached to the written application prescribed in the preceding paragraph.
(Notification of Changes)
Article 127When a registered certification body plans to change matters set forth in the following items, it must submit a notification based on Form No. 6 by two weeks before the scheduled date of change:
(i)matters provided in Article 23-8, paragraph (2) of the Act;
(ii)officers (partners who execute the business in a membership company) or business operators;
(iii)the name and scope of business of an examiner;
(iv)businesses operations other than the examination for certification of conformity;
(v)the scope of specially-controlled medical devices, controlled medical devices, or medical devices or in-vitro diagnostics, which are used in activities of the certification of conformity.
(Examination Standards for Registered Certification Bodies)
Article 128The standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-9, paragraph (2) of the Act are the following standards beyond those concerning bodies that certify products and those concerning bodies that examine means of manufacturing and quality control, both of which are specified by the International Organization for Standardization (ISO) and the International Electro Technical Commission (IEC):
(i)it is capable of collecting information necessary to examination for the certification of conformity;
(ii)it is capable of preparing records, etc. of the examination which are the grounds for the results of the certification of conformity;
(iii)in cases where the internal audit and the improvement of activities related to the certification of conformity are required, it is capable of preparing records of the measures and keeping them as well as taking necessary measures;
(iv)it is capable of demonstrating qualification requirements for an examiner of certification of conformity and taking necessary measures including education and training;
(v)it is capable of conducting necessary business operations to properly perform other activities concerning the certification of conformity.
(Operational Rules of Registered Certification Bodies)
Article 129(1)A registered certification body must submit a written application based on Form No. 73 with the operational rules (the original and a duplicate) attached thereto to the Minister of Health, Labour and Welfare to obtain authorization for the operational rules pursuant to the provisions of the first sentence of Article 23-10, paragraph (1) of the Act.
(2)A registered certification body must submit a written application based on Form No. 74 with the operational rules after the change (the original and a duplicate) attached thereto to the Minister of Health, Labour and Welfare to obtain authorization for change of the operational rules pursuant to the provisions of the second sentence of Article 23-10, paragraph (1) of the Act.
(3)Matters to be specified by a registered certification body in operational rules pursuant to the provisions of Article 23-10, paragraph (2) of the Act are as follows:
(i)the means of implementing the certification of conformity;
(ii)fees for the certification of conformity;
(iii)the means of making partial change or cancellation of the certification of conformity;
(iv)the means of conducting the internal audit;
(v)the qualification requirements for an examiner depending on the scope of activities in the certification of conformity;
(vi)matters related to designation and dismissal of an examiner;
(vii)the means of maintaining and controlling abilities of an examiner;
(viii)the means of filing objections and handling complaints;
(ix)the means of preserving records concerning the certification of conformity and implementing management.
(Issuance of Authorization Certificate for Operational Rules)
Article 129-2(1)The Minister of Health, Labour and Welfare must issue an authorization certificate to an applicant for authorization when granting authorization prescribed in Article 23-10, paragraph (1) of the Act.
(2)The authorization certificate prescribed in the preceding paragraph is to be based on Form No. 74-2.
(Matters to Be Included in Books)
Article 130(1)The matters specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-11 of the Act are matters specified in the standards concerning bodies that certify products and the standards concerning bodies that examine means of manufacturing and quality control, both of which are specified by the International Organization for Standardization (ISO) and the International Electro Technical Commission (IEC).
(2)When matters set forth in the preceding paragraph are recorded in a file on a computer, a magnetic disk, or CD-ROM and as required, are labeled clearly on paper by using the computer and other equipment at the registered certification body, the records may be replaced with books.
(3)A registered certification body must manage books (including a file or a magnetic disk, or CD-ROM where matters are recorded pursuant to the provisions of the preceding paragraph) by means specified by the standards concerning bodies that certify products and the standards concerning bodies that examine means of manufacturing and quality control, both of which are specified by the International Organization for Standardization (ISO) and the International Electro Technical Commission (IEC), and maintain them for 15 years from the date when all certifications described in the books are abolished or canceled.
(Application for Certification of Conformity)
Article 131(1)An application under Article 23-14 of the Act is to be carried out by submitting a written application based on Form No. 75 to the Minister of Health, Labour and Welfare.
(2)The overview pertaining to the application and other necessary data must be attached to the written application prescribed in the preceding paragraph.
(Notification of Suspension or Abolition)
Article 132The notification under Article 23-15, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 8 by two weeks before the date when all or part of business operations in the certification of conformity are suspended or abolished.
(Means of Indicating Electronic or Magnetic Records)
Article 133The means specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-17, paragraph (2), item (iii) of the Act are means to indicate matters recorded in electronic or magnetic records on paper or on the screen of an output device.
(Means of Providing Electronic or Magnetic Records)
Article 134The means specified by Order of the Ministry of Health, Labour and Welfare under Article 23-17, paragraph (2), item (iv) of the Act are the means specified by a registered certification body from among those set forth in the following respective items:
(i)a means that uses electronic data processing systems that connects a computer used by a sender with a computer used by a receiver through telecommunication lines whereby the information is sent via the telecommunication lines and recorded in files on a computer used by the receiver;
(ii)a means to deliver content of information recorded on a file prepared using a magnetic disk or any other equivalent media on which certain information can be securely recorded.
(Conformity Certification Operations by the Minister of Health, Labour and Welfare)
Article 135(1)The provisions of Articles 115 through 118-2 apply mutatis mutandis to the certification of conformity granted by the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-18, paragraph (1) of the Act.In this case, "registered certification body" in these provisions is deemed to be replaced with "the Minister of Health, Labour and Welfare".
(2)The provisions of Articles 115 through 119 (excluding paragraph (3)) apply mutatis mutandis to the certification of conformity granted by the PMDA pursuant to the provisions of Article 23-18, paragraph (2) of the Act.In this case, "registered certification body" in these provisions is deemed to be replaced with "the PMDA".
(Succession of Conformity Certification Operations)
Article 136(1)A registered certification body must undertake the following matters in cases provided in Article 23-18, paragraph (4) of the Act:
(i)the activities for certification of conformity are taken over from the Minister of Health, Labour and Welfare;
(ii)the books and documents (including electronic or magnetic records) for certification of conformity are taken over from the Minister of Health, Labour and Welfare;
(iii)such other matters recognized by the Minister of Health, Labour and Welfare as necessary.
(2)In applying the provisions of the preceding paragraph when the Minister of Health, Labour and Welfare decides to have the PMDA conduct all or part of activities for certification of conformity pursuant to the provisions of Article 23-18, paragraph (2) of the Act, the term "Minister of Health, Labour and Welfare" in the preceding paragraph is deemed to be replaced with "PMDA".
(Notification to the Minister of Health, Labour and Welfare)
Article 137A registered certification body must immediately notify the Minister of Health, Labour and Welfare when they find a violation of the provisions of pharmaceutical laws and regulations in the business.
Chapter IV Marketing and Manufacturing Regenerative Medicine Products
(Application for License for Marketing Regenerative Medicine Products)
Article 137-2(1)The application for license for marketing regenerative medicine products prescribed in Article 23-20, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 9 to a prefectural governor who is responsible for activities concerning the license pursuant to the provisions of Article 80 of the Order.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the written applications at the time of application and other acts or submitted to the Minister of Health, Labour and Welfare via the prefectural governor, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)a doctor's written diagnosis with regard to mental impairment of an applicant (if the applicant is a corporation, the officer responsible for the operation; the same applies hereinafter in this item) or whether or not the applicant is addicted to narcotics, cannabis, opium, or stimulants;
(iii)in case where an applicant actually receives a license for marketing, a copy of the license certificate for marketing;
(iv)if an applicant is a corporation, the organization chart;
(v)if a person other than an applicant is a marketing director of regenerative medicine products, a copy of an employment agreement and other application proving an employment relationship between the applicant and the marketing director of regenerative medicine products;
(vi)documents proving the marketing director of regenerative medicine products is a person provided in Article 23-34, paragraph (1) of the Act;
(vii)documents concerning the system concerning quality control;
(viii)documents concerning the system related to post-marketing safety control.
(3)In cases where the applicant is a corporation, and where a prefectural governor who is responsible for activities concerning the license pursuant to the provisions of Article 80 of the Order acknowledges that, judging from duties of the officer, the business operation is not adversely affected, the applicant may submit a document proving the officer does not fall under Article 5, item (iii), (e) and (f) of the Act in place of a written diagnosis set forth in item (ii) of the preceding paragraph.
(4)The provisions of Article 9 apply mutatis mutandis pursuant to an application prescribed in paragraph (1).In this case, "prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head for the special ward)" in the same Article is deemed to be replaced with "prefectural governor".
(Form of License Certificate for Marketing)
Article 137-3The license certificate for marketing regenerative medicine products is to be based on Form No. 10.
(Application for Updated Issuance of License Certificate for Marketing)
Article 137-4A written application prescribed in Article 43-4, paragraph (2) of the Order is to be based on Form No. 3.
(Application for Reissuance of License Certificate for Marketing)
Article 137-5A written application prescribed in Article 43-5, paragraph (2) of the Order is to be based on Form No. 4.
(Application for Renewal of License for Marketing)
Article 137-6(1)An application for a renewal of license for marketing regenerative medicine products prescribed in Article 23-20, paragraph (2) of the Act is to be made by submitting a written application based on Form No. 11 to a prefectural governor who is responsible for activities related to the authority pursuant to the provisions of Article 80 of the Order.
(2)The license certificate of a license concerning the application must be attached to the written application prescribed in the preceding paragraph.
(Matters to Be Included in Registry of License for Marketing)
Article 137-7Matters to be included in the registry of license prescribed in Article 23-20, paragraph (1) of the Act provided in Article 43-7, paragraph (1) of the Order are as follows:
(i)the license number and date;
(ii)the name and address of the holder of marketing authorization;
(iii)the name and location of the office where the marketing director of regenerative medicine products performs the activities (hereinafter referred to as the "office with major functions" in this chapter);
(iv)the name and address of the marketing director of regenerative medicine products;
(v)in case where the holder of marketing authorization receives another type of license for marketing, the type of the license and the license number.
(Application for License for Manufacturing)
Article 137-8(1)The application for license for manufacturing of regenerative medicine products prescribed in Article 23-22, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 12 (the original and two duplicates) to the Director of the Regional Bureau of Health and Welfare who is responsible for activities concerning the license pursuant to the provisions of Article 281.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Director of the Regional Bureau of Health and Welfare who is in charge of receiving the written applications at the time of application and other acts or submitted to the Director of the Regional Bureau of Health and Welfare via a prefectural governor, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a certificate of registered information;
(ii)application which show the applicant does not fall under Article 5, item (iii), (e) and (f) of the Act;
(iii)if a person other than an applicant is a manufacturing supervisor of regenerative medicine products, a copy of an employment agreement and other application proving an employment relationship between the applicant and the manufacturing supervisor of regenerative medicine products;
(iv)documents proving the manufacturing supervisor of regenerative medicine products is a person who has obtained an approval prescribed in Article 23-34, paragraph (3) of the Act;
(v)documents concerning structure and equipment at the manufacturing facility;
(vi)a list of items to be manufactured and documents concerning a production process;
(vii)if an applicant has obtained another license or registration for manufacturing or has obtained a license for manufacturing the specified processed cells prescribed in Article 35, paragraph (1) of the Act on the Safety of Regenerative Medicine Products Safety. (Act No. 85 of 2013; hereinafter referred to as the "Act on Securement of Safety of Regenerative Medicine Products"), a copy of the license certificate or the registration certificate for manufacturing or the license certificate for manufacturing the specified processed cells.
(3)The provisions of Article 9 apply mutatis mutandis pursuant to an application prescribed in paragraph (1).In this case, "prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward)" in the same Article is deemed to be replaced with "the Director of the Regional Bureau of Health and Welfare".
(License Criteria for Manufacturing)
Article 137-9The license criteria for manufacturing regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-22, paragraph (2) of the Act are as follows:
(i)type of manufacturing where all or part of the manufacturing process for regenerative medicine products is performed (excluding those set forth in the following item);
(ii)type of manufacturing where only wrapping, labeling, and storing are conducted in the manufacturing process for regenerative medicine products.
(Form of License Certificate for Manufacturing)
Article 137-10The license certificate for manufacturing regenerative medicine products is to be based on Form No. 13.
(Application for Updated Issuance of License Certificate for Manufacturing)
Article 137-11(1)A written application prescribed in Article 43-11, paragraph (2) of the Order (the original and a duplicate) is to be based on Form No. 3.
(2)A fiscal stamp equivalent to the fee must be affixed to a written application prescribed in the preceding paragraph.
(Application for Reissuance of License Certificate for Manufacturing)
Article 137-12(1)A written application prescribed in Article 43-12, paragraph (2) of the Order (the original and a duplicate) is to be based on Form No. 4.
(2)A fiscal stamp equivalent to the fee must be affixed to a written application prescribed in the preceding paragraph.
(Application for Renewal of License for Manufacturing)
Article 137-13(1)An application for renewal of license for manufacturing regenerative medicine products prescribed in Article 23-22, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 14 (the original copy and two duplicates) to the Director of the Regional Bureau of Health and Welfare.
(2)The license certificate of a license pertaining to an application must be attached to the written application prescribed in the preceding paragraph.
(Application for Changes of License Criteria for Manufacturing)
Article 137-14(1)An application for a license for change or addition to the criteria for license for manufacturing regenerative medicine products prescribed in Article 23-22, paragraph (6) of the Act is to be made by submitting a written application based on Form No. 15 (the original copy and two duplicates) to the Director of the Regional Bureau of Health and Welfare.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Director of the Regional Bureau of Health and Welfare who is in charge of receiving the written applications at the time of application and other acts or submitted to the Director of the Regional Bureau of Health and Welfare via a prefectural governor, if the written application has a supplementary note to that effect:
(i)a license certificate;
(ii)a list of items to be manufactured concerning changes or additions and documents concerning a manufacturing process;
(iii)a document concerning structure and equipment of a manufacturing facility concerning the license criteria to be changed or added.
(Matters to Be Included in Registry of License for Manufacturing)
Article 137-15Matters to be included in the registry of license prescribed in Article 23-22, paragraphs (1) and (6) of the Act provided in Article 43-14 of the Order are as follows:
(i)the license number and date;
(ii)the license criteria;
(iii)the name and address of the manufacturer;
(iv)the name and location of the manufacturing facility;
(v)the name and address of a manufacturing supervisor of regenerative medicine products in manufacturing facility;
(vi)if the manufacturer has obtained another license or registration for manufacturing or license for manufacturing specified processed cells prescribed in Article 35, paragraph (1) of the Act on the Safety of Regenerative Medicine Products, the license criteria, license number and the registration number for manufacturing, or the license number for manufacturing the specified processed cells.
(Application for Investigation Concerning License for Manufacturing or Renewal of License to the PMDA)
Article 137-16(1)When it is decided to have the PMDA undergo the investigation prescribed in Article 23-22, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) pursuant to the provisions of Article 23-23, paragraph (1) of the Act, an applicant for license prescribed in Article 23-22, paragraph (1) or (6) of the Act related to regenerative medicine products provided in Article 43-15 of the Order or renewal of a license prescribed in paragraph (3) of the same Article must apply for the investigation to the PMDA.
(2)The application prescribed in the preceding paragraph is to be made by attaching a written application based on Form No. 16 to a written application for license prescribed in Article 23-22, paragraph (1) or (6) of the Act for items related to the application or a written application for renewal of license prescribed in paragraph (3) of the same Article, and providing it via the Director of the Regional Bureau of Health and Welfare.
(Notification of Results of Investigation Concerning License for Manufacturing or Renewal of License by the PMDA)
Article 137-17The notification of results of investigation under Article 23-23, paragraph (4) of the Act is to be given by a notification based on Form No. 17 to the Director of the Regional Bureau of Health and Welfare.
(Application for Accreditation of Certified Foreign Manufacturer of Regenerative Medicine Products)
Article 137-18(1)An application for accreditation of a foreign manufacturer of regenerative medicine products under Article 23-24, paragraph (1) of the Act is to be made by submitting written applications based on Form No. 18 (the original and a duplicate).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)application which show the applicant (an officer responsible for the business if the applicant is a corporation) does not fall under Article 5, item (iii), (e) and (f) of the Act;
(ii)a resume of a person in charge of the manufacturing facility;
(iii)a list of items to be manufactured and documents concerning the production process;
(iv)documents concerning structure and equipment at the manufacturing facility;
(v)in cases where a country where the foreign manufacturer of regenerative medicine products exists has a system of license for marketing or manufacturing regenerative medicine products, or approval for marketing regenerative medicine products, or system corresponding to the same, copies of license certificate, etc. issued by a governmental organization of the country concerning the system.
(Accreditation Criteria for Foreign Manufacturers of Regenerative Medicine Products)
Article 137-19The accreditation criteria for a foreign manufacturer of regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-24, paragraph (2) of the Act are as follows:
(i)foreign manufacturer that conducts all or part of the manufacturing process for regenerative medicine products (excluding those set forth in the following item);
(ii)foreign manufacturer that conducts only wrapping, labeling, and storing in the manufacturing process for regenerative medicine products.
(Application, Mutatis Mutandis)
Article 137-20(1)The provisions of Articles 37-10 through 137-17 apply mutatis mutandis to accreditation prescribed in Article 23-24, paragraph (1) of the Act.
(2)In cases prescribed in the preceding paragraph, in the provisions set forth in the left-hand column of the following table, the terms and phrases set forth in the middle column of the same table are deemed to be replaced with those set forth in the right-hand column of that table.
Article 137-10
license certificate for manufacturing regenerative medicine products
Accreditation certificate for foreign manufacturer of regenerative medicine products
Form No. 13
Form No. 19
Article 137-11, paragraph (1)
Article 43-11, paragraph (2)
Article 43-18, paragraph (2)
Article 137-12, paragraph (1)
Article 43-12, paragraph (2)
Article 43-19, paragraph (2)
Article 137-13, paragraph (1)
Act
The Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
license for manufacturing regenerative medicine products
accreditation prescribed in Article 23-24, paragraph (1) of the Act (hereinafter called the "accreditation of foreign manufacturer of regenerative medicine products")
Form No. 14
Form No. 20
the original copy and two duplicates) to the Director of the Regional Bureau of Health and Welfare
the original and a duplicate) to the Minister of Health, Labour and Welfare
Article 137-13, paragraph (2)
license certificate for license
accreditation certificate for accreditation
Article 137-14, paragraph (1)
Act
The Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
License for manufacturing regenerative medicine products
Accreditation of foreign manufacturer of regenerative medicine products
license for addition of classification
authorization for addition of classification
Form No. 15
Form No. 21
the original copy and two duplicates) to the Director of the Regional Bureau of Health and Welfare
the original and a duplicate) to the Minister of Health, Labour and Welfare
Parts other than listed in each of the items in Article 137-14, paragraph (2)
submitted to the Director of the Regional Bureau of Health and Welfare who is in charge of receiving the written applications ... or submitted to the Director of the Regional Bureau of Health and Welfare via a prefectural governor
the Minister of Health, Labour and Welfare
Article 137-14, paragraph (2), item (i)
A license certificate
An accreditation certificate
Article 137-14, paragraph (2), item (iii)
license
accreditation
Parts other than listed in each of the items in Article 137-15
license prescribed in Article 23-22, paragraphs (1) and (6) of the Act provided in Article 43-14
accreditation prescribed in Article 23-24, paragraph (1) of the Act provided in Article 43-14 of the Order as applied mutatis mutandis pursuant to Article 43-17, and Article 23-22, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
Article 137-15, item (i)
license number and date
accreditation number and date
Article 137-15, item (ii)
license
accreditation
Article 137-15, item (iii)
manufacturer
foreign manufacturer of regenerative medicine products
Article 137-15, item (v)
Manufacturing supervisor of regenerative medicine products
A responsible person
Article 137-15, item (vi)
manufacturer
foreign manufacturer of regenerative medicine products
a license or registration for manufacturing or license for manufacturing specified processed cells prescribed in Article 35, paragraph (1) of the Act on the Safety of Regenerative Medicine Products
an accreditation of a foreign manufacturer of pharmaceuticals, etc., or a foreign manufacturer of regenerative medicine products, or registration of foreign manufacturer of Medical Devices, etc.
criteria, license number, or registration number for manufacturing license, or a the license number for manufacturing the specified processed cells
criteria and accreditation number or registration number for accreditation
Article 137-16, paragraph (1)
Article 23-23, paragraph (1)
Article 23-23, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3)
Article 23-22, paragraph (5)
Article 23-22, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3)
License prescribed in Article 23-22, paragraph (1) or (6) or license prescribed in paragraph (3) of the same Article
accreditation of prescribed in Article 23-24, paragraph (1), or Article 23-22, paragraph (6) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) or the accreditation prescribed in Article 23-22, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
Article 137-16, paragraph (2)
license prescribed in Article 23-22, paragraph (1) or (6) or the license prescribed in paragraph (3) of the same Article
accreditation prescribed in Article 23-24, paragraph (1), or Article 23-22, paragraph (6) of the Actas applied mutatis mutandis pursuant to Article 23-24, paragraph (3) or the accreditation prescribed in Article 23-22, paragraph (3) of the Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
Article 137-17
Act
Act as applied mutatis mutandis pursuant to Article 23-24, paragraph (3) of the Act
the Director of the Regional Bureau of Health and Welfare
the Minister of Health, Labour and Welfare
(Application for Marketing Approval for Regenerative Medicine Products Manufactured in Foreign Countries)
Article 137-21(1)An application for approval for marketing regenerative medicine products prescribed in Article 23-25, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 75-2 (the original copy and two duplicates).
(2)The following documents must be attached to the written application prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare who is in charge of receiving the written applications at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)a copy of a license certificate for marketing concerning the items;
(ii)documents clearly indicating that materials intended to be marketed by an applicant are regenerative medicine products provided in Article 23-28, paragraph (1), item (ii) of the Act when applying for an approval prescribed in Article 23-25, paragraph (1) of the Act pursuant to the provisions of Article 23-28, paragraph (1) of the Act.
(Cases Where Regenerative Medicine Products Are Inappropriate as Regenerative Medicine Products)
Article 137-22Cases where regenerative medicine products are specified by Order of the Ministry of Health, Labour and Welfare as not being appropriate as regenerative medicine products prescribed in Article 23-25, paragraph (2), item (iii), (c) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article; the same applies in the following paragraph) are the cases where the properties or qualities of regenerative medicine products related to the application are remarkably inappropriate with regard to health and hygiene.
(Data to Be Attached to Written Applications for Approval)
Article 137-23(1)The data which is required to be attached to a written application prescribed in Article 137-21, paragraph (1) or Article 137-27, paragraph (1) pursuant to the provisions of Article 23-25, paragraph (3) of the Act (including cases as applied mutatis mutandis pursuant to paragraph (9) of the same Article and cases as applied following the deemed replacement of terms pursuant to the provisions of Article 23-26, paragraph (5) of the Act; the same applies in the following paragraph) is the following data depending on component cells, types of transgenes, routes, structures, performances of regenerative medicine products, related to the application:
(i)data concerning origin or background of discovery and conditions of use in foreign countries, etc.;
(ii)data concerning manufacturing methods, standards and test methods, etc.;
(iii)data concerning stability;
(iv)data concerning efficacy, effect or performance;
(v)data concerning in vivo kinetics;
(vi)data concerning non clinical safety;
(vii)data concerning test results of clinical studies;
(viii)data concerning risk analysis;
(ix)data concerning particulars to be indicated on package inserts provided in Article 65-3 of the Act.
(2)Notwithstanding the provisions of the preceding paragraph, with respect to the data to be attached to written applications prescribed in Article 137-21, paragraph (1) or Article 137-27, paragraph (1) pursuant to the provisions of Article 23-25, paragraph (3) of the Act, if it is recognized that matters concerning the application exist in the public domain in the medical and pharmaceutical fields, or there are other reasonable grounds why the attachment of data is not required, the attachment is not required; provided, however, that if regenerative medicine products are found to have same component cell, transgenes, usage, dosage, usage method, efficacy, effect, and performance as those of new regenerative medicine products provided in Article 23-29, paragraph (1), item (i) of the Act, they are not considered to exist in the public domain in the medical and pharmaceutical fields other than cases where data is not required to be attached to an application for approval of the new regenerative medicine products while being reexamined.
(3)A test required to create data set forth in each of the items of paragraph (1) must be conducted at a test facility, etc. that has a facility, devices, and employees required to ensure the reliability of test results and is recognized to be properly operated and managed.
(4)When the data casts a doubt on whether regenerative medicine products pertaining to an application have sufficient quality, efficacy, or safety for the application, the applicant must submit the data to the Minister of Health, Labour and Welfare in cases where the test required to create the data has not been conducted at a test facility, etc. provided in the preceding paragraph.
(5)Beyond what is set forth in each of the items of paragraph (1) and what is provided in the preceding paragraph, if the Minister of Health, Labour and Welfare acknowledges the necessity for the examination for approval of regenerative medicine products and asks for the other submission of samples of regenerative medicine products, the applicant must submit the data to the minister.
(Suspension of Submission of Data to Be Attached to Written Applications for Approval of Regenerative Medicine Products Concerning Special Approval)
Article 137-24When an applicant acknowledges that data set forth in paragraph (1), items (i) through (vi), (viii) and (ix) of the preceding Article cannot be attached to the regenerative medicine products to be marketed with an approval prescribed in Article 23-25 of the Act under Article 23-28, paragraph (1) of the Act, the Minister of Health, Labour and Welfare may suspend the submission for a reasonable period of time.
(Standards for Reliability of Application Data)
Article 137-25The data provided in the second sentence of Article 23-25, paragraph (3) of the Act (including cases as applied mutatis mutandis pursuant to paragraph (9) of the same Article and cases as applied following the deemed replacement of terms pursuant to the provisions of Article 23-26, paragraph (5) of the Act) must be collected and prepared pursuant to the following provisions, beyond what is specified by the Ministerial Order on Standards for Non-Clinical Studies Concerning Safety of Regenerative Medicine Products (Order of the Ministry of Health, Labour and Welfare No. 88 of 2004), the Ministerial Order on Standards for Clinical Studies of Regenerative Medicine Products (Order of the Ministry of Health, Labour and Welfare No. 89 of 2004) and the Ministerial Order on Standards for Post-Marketing Surveillance and Test of Regenerative Medicine Products (Order of the Ministry of Health, Labour and Welfare No. 90 of 2004):
(i)the data is correctly prepared based on results of the investigation or the test conducted for the purpose of preparing the data;
(ii)in the case of results of the investigation or the test in the preceding item cast a doubt on whether regenerative medicine products pertaining to an application have sufficient quality, efficacy, or safety for the application, results of the investigation and the test are reviewed and evaluated and the results are described in the data;
(iii)data on which the relevant data is based is preserved until the date of disposition when the approval prescribed in Article 23-25, paragraph (1) of the Act (excluding those with conditions and the time limit added pursuant to the provisions of Article 23-26, paragraph (1) of the Act) or approval prescribed in paragraph (9) of the same Article is granted or not granted; provided, however, that this does not apply to the case where it is recognized that the nature of the data makes it extremely difficult to preserve.
(Data That Can Be Replaced with Documents Certifying the Registration in Drug Master File)
Article 137-26A person who intends to apply for an approval prescribed in Article 23-25, paragraph (1) or (9) of the Act may replace a part of data set forth in Article 137-23, paragraph (1), items (ii) through (iv) from among the data provided in Article 23-25, paragraph (3) of the Act with a copy of a registration certificate prescribed in Article 280-4, paragraph (2), an agreement with a registered manufacturer of active ingredients, etc. regarding the active ingredients, etc. and other documents certifying the use of the active ingredients, etc. as items pertaining to the application.
(Approval of Partial Changes to Approved Matters)
Article 137-27(1)An application for approval of marketing regenerative medicine products prescribed in Article 23-25, paragraph (9) of the Act is to be made by submitting a written application based on Form No. 75-3 (the original copy and two duplicates).
(2)When an application for approval prescribed in Article 23-25, paragraph (9) of the Act is to be made pursuant to the provisions of Article 23-28, paragraph (1) of the Act, documents set forth in Article 137-21, paragraph (2), item (ii) must be attached to a written application prescribed in the preceding paragraph.
(Scope of Minor Changes of Approved Matters)
Article 137-28Minor changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-25, paragraph (9) of the Act are ones other than those set forth in each of the following items:
(i)changes of manufacturing methods, etc. influencing essential qualities, features, and safety of the item;
(ii)deletion of matters set forth in the standard and the test method and changes of the standard;
(iii)changes concerning the inactivation or removal method for pathogenic factors;
(iv)addition, change, or deletion of usage, dosage, usage method, or efficacy, effects or performance;
(v)beyond changes set forth in each of the preceding items, those that may influence the quality, efficacy, and safety of the product.
(Notification of Minor Changes)
Article 137-29(1)A notification under Article 23-25, paragraph (10) of the Act is to be given by submitting a written application based on Form No. 75-4 (the original and a duplicate) to the Minister of Health, Labour and Welfare.
(2)The notification prescribed in the preceding paragraph must be within 30 days after minor changes prescribed in Article 23-25, paragraph (9) of the Act.
(3)In applying the provisions of paragraph (1) when the Minister of Health, Labour and Welfare decides to have the PMDA undergo an examination on regenerative medicine products provided in Article 23-27, paragraph (1) of the Act pursuant to the provisions of Article 23-27, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to Article 23-37, paragraphs (5) and (6) of the Act), the term "Minister of Health, Labour and Welfare" in paragraph (1) is deemed to be replaced with "PMDA".
(Matters to Be Included in Registry of Approval)
Article 137-30Matters to be included in the registry of approval prescribed in Article 23-25, paragraphs (1) and (9) of the Act provided in Article 43-22 of the Order:
(i)the approval number and date;
(ii)the name and address of a person who obtained approval;
(iii)the type and license number for the marketing license of a person who obtained approval;
(iv)the name and location of the manufacturing facility of the item;
(v)the criteria and license number for the license of manufacturers or the criteria and accreditation number for the accreditation of foreign manufacturers received by a manufacturing facility of the item;
(vi)the name of the item;
(vii)the component and quantity, or shape, structure, and principle of the item;
(viii)the efficacy, effect, or purpose of use of the item;
(ix)the usage and dosage, or the use of the item;
(x)the standard and the test method for the item.
(Application for Compliance Investigation of Regenerative Medicine Products)
Article 137-31(1)The application for investigation under Article 23-25, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) (hereinafter referred to as the "compliance investigation of regenerative medicine products" in this chapter) is to be made by submitting a written application based on Form No. 75-5 to the Minister of Health, Labour and Welfare.
(2)The following documents must be attached to the written application prescribed in the preceding paragraph:
(i)data concerning the manufacturing and quality management of the item concerning the compliance investigation of regenerative medicine products;
(ii)data concerning the manufacturing and quality management of the manufacturing facility concerning the compliance investigation of regenerative medicine products.
(3)In applying the provisions of paragraph (1) when the Minister of Health, Labour and Welfare decides to have the PMDA undergo a compliance investigation of regenerative medicine products pursuant to the provisions of Article 23-27, paragraph (1) of the Act, the term "Minister of Health, Labour and Welfare" in paragraph (1) is deemed to be replaced with "PMDA".
(Notification of Results of Compliance Investigation of Regenerative Medicine Products)
Article 137-32A notification of the results of the compliance investigation of regenerative medicine products to be given by a person conducting a compliance investigation of regenerative medicine products (meaning a person conducting a compliance investigation of regenerative medicine products provided in Article 43-25 of the Order) to a person granting licenses for marketing regenerative medicine products (meaning a person granting licenses for marketing regenerative medicine products provided in the same Article) pursuant to the provisions of the same Article is to be given by using a written notice based on Form No. 75-6.
(Matters to Be Included in Registry of Compliance Investigations of Regenerative Medicine Products)
Article 137-33Matters to be included in the registry concerning the compliance investigation of regenerative medicine products provided in Article 43-26 of the Order are as follows:
(i)investigation results and notification date;
(ii)the name of the item;
(iii)the name and address of a person who intends to receive or has accepted marketing approval for the item;
(iv)the approval number and date (limited to the in case where the person set forth in the preceding item has already obtained the marketing approval for the item);
(v)the name and location of the manufacturing facility;
(vi)the name and address of a manufacturer or a foreign manufacturer of regenerative medicine products;
(vii)the license number and date of the license for manufacturing received by the manufacturer prescribed in the preceding item or the accreditation number and date received by a foreign manufacturer of regenerative medicine products.
(Changes to Approved Matters Excluded from Compliance Investigation of Regenerative Medicine Products Products)
Article 137-34Changes specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 43-27, paragraph (1) of the Order do not influence the additions, changes, or deletions of usage, dosage, efficacy or effect indications and other methods to control manufacturing or quality of the item.
(Reports of Investigation on Results of Usage of New Regenerative Medicine Products Which Obtained Approval with Conditions and Time Limit and Results)
Article 137-35(1)For regenerative medicine products which obtained an approval prescribed in Article 23-25, paragraph (1) of the Act with conditions and the time limit added pursuant to the provisions of Article 23-26, paragraph (1) of the Act, the investigation prescribed in Article 23-26, paragraph (3) of the Act carried out by the approved person is to be undergone on failures, etc. of the regenerative medicine products and other results of usage for the period until the time limit (for the extended period if the period was extended pursuant to the provisions of paragraph (2) of the same Article).
(2)The report to the Minister of Health, Labour and Welfare under Article 23-26, paragraph (3) of the Act is to cover the following matters:
(i)the name of the regenerative medicine products;
(ii)the approval number and date;
(iii)the period for investigation and the number of investigated cases;
(iv)the shipping quantity of the regenerative medicine products;
(v)the summary and analysis results of investigation results;
(vi)the expression status of failure, etc. classified by category;
(vii)the list of expression cases of failure, etc.
(3)The reports prescribed in the preceding paragraph must be made annually (in the case of regenerative medicine products instructed by the Minister of Health, Labour and Welfare, the period instructed by the Minister) from the date when marketing regenerative medicine products concerning the investigation is approved, within two months after the expiry of the period.
(Application to the PMDA for Examination or Investigation of Marketing Approval of Regenerative Medicine Products)
Article 137-36(1)When it is determined to have the PMDA undergo an examination for approval prescribed in Article 23-25 of the Act pursuant to the provisions of Article 23-27, paragraph (1) of the Act, an applicant for approval prescribed in Article 23-25, paragraph (1) or (9) of the Act concerning regenerative medicine products provided in Article 43-29 of the Order must apply to the PMDA for the examination.
(2)When it is determined to have the PMDA undergo the investigation prescribed in the second sentence of Article 23-25, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) pursuant to the provisions of Article 23-27, paragraph (1) of the Act, the applicant for approval prescribed in Article 23-25, paragraph (1) or (9) of the Act on regenerative medicine products provided in Article 43-29 of the Order must apply to the PMDA for the investigation.
(3)The applications prescribed in the preceding two paragraphs are to be conducted by attaching a written application based on Form No. 75-7 to a written application for approval prescribed in Article 23-25, paragraph (1) or (9) of the Act of the item concerning the application.
(4)The provisions of Article 137-23, paragraph (5) apply mutatis mutandis to the examination conducted by the PMDA for the approval prescribed in Article 23-25 of the Act and the investigation prescribed in paragraph (5) of the same Article (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) (hereinafter referred to as the "examination, etc. on regenerative medicine products" in the following Article) pursuant to the provisions of Article 23-27, paragraph (1) of the Act.In this case, "beyond what is set forth in each of the items of paragraph (1) and what is provided in the preceding paragraph, the Minister of Health, Labour and Welfare" in Article 137-23, paragraph (5) is deemed to be replaced with "the PMDA", "examination" with "examination or an investigation prescribed in Article 23-25, paragraph (5) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article)", and "Minister of Health, Labour and Welfare or a prefectural governor" with "Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Examinations on Regenerative Medicine Products by the PMDA)
Article 137-37(1)A notification of results of an examination, etc. on regenerative medicine products to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act is to be given by using a notification based on Form No. 75-8.
(2)A notification of investigation results prescribed in Article 23-25, paragraph (6) of the Act (including as applied mutatis mutandis pursuant to paragraph (9) of the same Article) to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act is to be given by using a notification based on Form No. 75-6.
(3)A notice of a notification status under Article 23-25, paragraph (10) of the Act to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act is to be given by using a notification based on Form No. 29.
(Application for Examination on New Regenerative Medicine Products)
Article 137-38An application for reexamination on regenerative medicine products set forth in each of the items of Article 23-29, paragraph (1) of the Act under the same paragraph is to be given by submitting a written application based on Form No. 75-9 (the original copy and two duplicates).
(Regenerative Medicine Products Specified by Order of the Ministry of Health, Labour and Welfare Concerning the Investigation Period on the Reexamination)
Article 137-39(1)The regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-29, paragraph (1), item (i), (a) of the Act are regenerative medicine products other than orphan regenerative medicine products for which investigations on failures, etc. of the regenerative medicine products and other results of usage are found to be required for more than six years since the day of approval for marketing (excluding those with the time limit and conditions added pursuant to the provisions of Article 23-26, paragraph (1) of the Act; the same applies in the following paragraph and paragraph (1) of the following Article).
(2)Regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-29, paragraph (1), item (i), (b) of the Act are regenerative medicine products for which marketing approval has been given and its usage (excluding the routes of administration) or which have clearly different dosage or usage, regenerative medicine products with the same component cells or transgenes and the same routes of administration (excluding regenerative medicine products set forth in (a) of the same item), and regenerative medicine products recognized as those which have minor differences from regenerative medicine products that have obtained an approval for their marketing (excluding regenerative medicine products set forth in (a) of the same item).
(Data to Be Attached to Written Applications for Reexamination)
Article 137-40(1)Data to be attached to a written application prescribed in Article 137-38 pursuant to the provisions of Article 23-29, paragraph (4) of the Act are data concerning the results of usage of the regenerative medicine products pertaining to the application, and studies reporting the efficacy, effect, or performance and safety of regenerative medicine products obtained after the marketing approval.
(2)The provisions of Article 137-23, paragraph (3) apply mutatis mutandis to the data provided in the preceding paragraph.
(3)The provisions of Article 137-23, paragraph (4) apply mutatis mutandis to an applicant for reexamination prescribed in Article 23-29, paragraph (1) of the Act.
(4)Beyond what is provided in Article 137-23, paragraph (4) as applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph, if the Minister of Health, Labour and Welfare acknowledges it necessary to reexamine regenerative medicine products, and asks for submission of data, an applicant must submit the data to the Minister of Health, Labour and Welfare.
(Scope of Regenerative Medicine Products Concerning Investigation of Reexamination)
Article 137-41Regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in the second sentence of Article 23-29, paragraph (4) of the Act are regenerative medicine products set forth in each of the items of paragraph (1) of the same Article.
(Standards for Reliability of Documents Submitted for Application for Reexamination)
Article 137-42The provisions of Article 137-25 apply mutatis mutandis to the data provided in the second sentence of Article 23-29, paragraph (4) of the Act.In this case, "the date of disposition when the approval prescribed in Article 23-25, paragraph (1) of the Act (excluding the data with conditions and the time limit added pursuant to the provisions of Article 23-26, paragraph (1) of the Act) or paragraph (9) of the same Article is provided or not" in Article 137-25, item (iii) is deemed to be replaced with "the final date of reexamination prescribed in Article 23-29, paragraph (1) of the Act".
(Reports of Investigation on Results of Usage of New Regenerative Medicine Product and Results)
Article 137-43(1)With respect to regenerative medicine products set forth in each of the following items, a person obtaining an approval prescribed in Article 23-25 of the Act (excluding those with conditions and the period added pursuant to the provisions of Article 23-26, paragraph (1) of the Act; the same applies in paragraph (3)) is to perform the investigation prescribed in Article 23-29, paragraph (6) of the Act on failures, etc. of the regenerative medicine products and other results of usage for the period specified in the each of the following items:
(i)new regenerative medicine products provided in Article 23-29, paragraph (1), item (i) of the Act:the investigation period provided in the same item (the extended period if the period has been extended under paragraph (2) of the same Article);
(ii)regenerative medicine products instructed by the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-29, paragraph (1), item (ii) of the Act:from the day when a marketing approval of being obtained to the day preceding the first day of the period instructed by the Minister of Health, Labour and Welfare provided in the same item.
(2)Reports to the Minister of Health, Labour and Welfare under Article 23-29, paragraph (6) of the Act or reports to the PMDA under the first sentence of Article 23-30, paragraph (2) of the Act are to be on the following matters:
(i)the name of the regenerative medicine products;
(ii)the approval number and date;
(iii)the investigation period and the number of investigated cases;
(iv)the shipping quantity of the regenerative medicine products;
(v)the summary and analysis results of investigation results;
(vi)the expression status of failure, etc. classified by category;
(vii)the list of expression cases of failure, etc.
(3)The reports prescribed in the preceding paragraph must be made annually from the date when marketing regenerative medicine products concerning the investigation is approved (in the case of regenerative medicine products instructed by the Minister of Health, Labour and Welfare, the period instructed by the Minister), within two months after the expiry of the period.
(4)A notification of acceptance of a report prescribed in paragraph (2) to be given to the Minister of Health, Labour and Welfare pursuant to the second sentence of Article 23-30, paragraph (2) of the Act is to be given by using a notification based on Form No. 31.
(Application to the PMDA for Confirmation or Investigation of Reexamination)
Article 137-44(1)When it is determined to have the PMDA conduct the confirmation under Article 23-29, paragraph (3) of the Act or the investigation under paragraph (5) of the same Article (hereinafter referred to as the "confirmation of regenerative medicine products" in this Article and the following Article) pursuant to the provisions of Article 23-27, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-30, paragraph (1) of the Act, the applicant for reexamination prescribed in Article 23-29, paragraph (1) of the Act concerning regenerative medicine products provided in Article 43-31 of the Order must apply to the PMDA for the confirmation of the regenerative medicine products.
(2)In filing an application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 75-10 to a written application for reexamination prescribed in Article 23-29, paragraph (1) of the Act on the items concerning the application.
(3)The provisions of Article 137-40, paragraph (4) apply mutatis mutandis to the confirmation of regenerative medicine products performed by the PMDA pursuant to the provisions of Article 23-27, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-30, paragraph (1) of the Act.In this case, "the Minister of Health, Labour and Welfare ...beyond what is provided in Article 137-23, paragraph (4) as applied mutatis mutandis pursuant to paragraph (1) and the preceding paragraph" in Article 137-40, paragraph (4) is deemed to be replaced with "the PMDA", "reexamination" with "confirmation under Article 23-29, paragraph (3) of the Act or the investigation under paragraph (5) of the same Article", and "to the Minister of Health, Labour and Welfare" with "to the Minister of Health, Labour and Welfare via the PMDA".
(Notification of Results of Confirmation of Regenerative Medicine Products in Reexamination by the PMDA)
Article 137-45A notification of results of confirming regenerative medicine products to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 23-30, paragraph (1) of the Act is to be given by using a notification based on Form No. 75-11.
(Application for Reevaluation of Regenerative Medicine Products)
Article 137-46(1)A reevaluation of regenerative medicine products prescribed in Article 23-31 of the Act is to be applied for by submitting a written application based on Form No. 75-12 (the original copy and two duplicates).
(2)The provisions of Article 137-23, paragraph (3) apply mutatis mutandis to the data to be submitted for the reevaluation of regenerative medicine products prescribed in Article 23-31, paragraph (1) of the Act.
(3)The provisions of Article 137-23, paragraph (4) apply mutatis mutandis to an applicant for reevaluation of regenerative medicine products prescribed in Article 23-31, paragraph (1) of the Act.
(4)Regenerative medicine products specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-31, paragraph (4) of the Act are regenerative medicine products pertaining to designation by the Minister of Health, Labour and Welfare prescribed in paragraph (1) of the same Article.
(5)The provisions of Article 137-25 apply mutatis mutandis to the data provided in Article 23-31, paragraph (4) of the Act.In this case, "date of disposition whether an approval prescribed in Article 23-25, paragraph (1) of the Act (excluding those added with conditions and terms pursuant to the provisions of Article 23-26, paragraph (1) of the Act) or an approval prescribed in paragraph (9) of the same Article is given or not" in Article 137-25, item (iii) is deemed to be replaced with "final date of reevaluation prescribed in Article 23-31 of the Act".
(Notification of Results of Examinations on Regenerative Medicine Products by the PMDA)
Article 137-37(1)A notification of the results of examinations on regenerative medicine products to be given to the Minister of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act is to be given by using a notification based on Form No. 75-8.
(2)In filing an application prescribed in the preceding paragraph, the applicant is to attach a written application based on Form No. 75-13 to a written application for reevaluation prescribed in Article 23-31, paragraph (1) of the Act of the item concerning the application.
(Notification of Results of Confirmation of Regenerative Medicine Products Related to Reevaluation by the PMDA)
Article 137-48A notification of results of confirming regenerative medicine products to be given to the Ministry of Health, Labour and Welfare pursuant to the provisions of Article 23-27, paragraph (5) of the Act as applied mutatis mutandis pursuant to Article 23-32, paragraph (1) of the Act is to be given by using a notification based on Form No. 75-14.
(Notification of Succession)
Article 137-49(1)The data and the information specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-33, paragraph (1) of the Act is as follows:
(i)data submitted at the time of application for license prescribed in Article 23-22, paragraph (1) of the Act (including as applied mutatis mutandis pursuant to paragraph (7) of the same Article) or accreditation prescribed in Article 23-24, paragraph (1) of the Act;
(ii)data submitted at the time of application for approval prescribed in Article 23-25, paragraph (1) of the Act and application for approval of partial change of the approved matters prescribed in paragraph (9) of the same Article, and data which the submitted data is based on;
(iii)data submitted at the time of the report under Article 23-26, paragraph (3) of the Act, and data which the submitted data is based on;
(iv)data submitted at the time of application for reexamination prescribed in Article 23-29, paragraph (1) of the Act, and data which the submitted data is based on;
(v)data submitted at the time of the report under Article 23-29, paragraph (6) of the Act, and data which the submitted data is based on;
(vi)data submitted at the time of application for reevaluation prescribed in Article 23-31, paragraph (1) of the Act, and data which the submitted data is based on;
(vii)records relating to regenerative medicine products under Article 68-7, paragraph (1) of the Act and data related to those records;
(viii)data and information concerning quality control operations;
(ix)data and information concerning post-marketing safety control activities;
(x)other data and information concerning quality, efficacy, and safety.
(2)A notification under Article 23-33, paragraph (3) of the Act is to be given by submitting a notification based on Form No. 75-15 (the original and a duplicate).
(3)A document proving that an applicant succeeds to the status of a person approved for regenerative medicine products must be attached to the notification prescribed in the preceding paragraph.
(Standards for Marketing Directors of Regenerative Medicine Products)
Article 137-50The standards specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-34, paragraph (1) of the Act concerning a person responsible for the quality control and the post-marketing safety control of regenerative medicine products stipulate that the person is to fall under any of the following items:
(i)a person who has graduated from a university, etc. by completing an advanced course in medicine, dentistry, pharmacology, veterinarian medicine, or biology at university, etc.;
(ii)a person who has experience in engaging in the work of quality control or post-marketing safety control of pharmaceuticals, Medical Devices, or regenerative medicine products for three years or more after graduating from a former secondary school, a high school, or a school equivalent or greater than the same by completing an advanced course in medicine, dentistry, pharmacology, veterinarian medicine, or biology;
(iii)a person who is recognized by the Minister of Health, Labour and Welfare.as having knowledge and experience equal to or greater than the persons set forth in the preceding two items
(Matters to Be Observed by Marketing Director of Regenerative Medicine Products)
Article 137-51Matters to be observed by a marketing director of regenerative medicine products provided in Article 23-34, paragraph (2) of the Act are as follows:
(i)being knowledgeable about laws and regulations and practices concerning operations related to quality control and post-marketing safety control activities and fairly and properly undertaking the operation;
(ii)expressing a necessary opinion in document to a holder of marketing authorization and maintaining a copy for five years if it is recognized that it is necessary for fairly and properly undertaking the operation;
(iii)closely cooperating with a person responsible for operations concerning quality control of regenerative medicine products (hereinafter referred to as a "quality assurance manager of regenerative medicine products") and a person responsible for the operation related to the post-marketing safety control (hereinafter referred to as a "safety control manager of regenerative medicine products").
(Approval for Manufacturing Supervisors of Regenerative Medicine Products)
Article 137-52(1)An application for approval prescribed in Article 23-34, paragraph (3) of the Act is to be made by submitting a written application based on Form No. 75-16 (the original copy and two duplicates).
(2)A resume of a person to be a manufacturing supervisor of regenerative medicine products must be attached to the written application prescribed in the preceding paragraph.
(Respect for Opinions of Manufacturing Supervisors of Regenerative Medicine Products)
Article 137-53A manufacturer of regenerative medicine products must respect opinions given by a manufacturing supervisor of regenerative medicine products who finds it necessary to perform obligations provided in Article 8, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-34, paragraph (4) of the Act.
(Records on Manufacturing and Tests)
Article 137-54A manufacturing supervisor of regenerative medicine products must prepare records concerning manufacturing and tests, and other records concerning the management of the manufacturing facility and must preserve records for three years in case required (in cases where it is required to enter the validity period of regenerative medicine products related to the record, a period resulting from adding one year to the validity period); provided, however, that this does not apply where the preparation and the retention of records are mandated pursuant to other provisions of this Regulation or those of other pharmaceutical laws and regulations.
(Matters to Be Observed by Holders of Marketing Authorization for Regenerative Medicine Products)
Article 137-55Matters to be observed by a holder of marketing authorization for regenerative medicine products provided in Article 23-35, paragraph (1) of the Act are as follows:
(i)consideration required for proper marketing according to pharmaceutical laws and regulations;
(ii)proper quality control of products to be marketed;
(iii)proper post-marketing safety control for products to be marketed;
(iv)a person with the expertise is appointed as an assistant to a marketing director of regenerative medicine products in cases where the marketing director of the regenerative medicine products, a quality assurance manager of regenerative medicine products, and a safety control manager of regenerative medicine products have no expertise concerning characteristics of items to be marketed;
(v)necessary considerations are given so that the marketing director of regenerative medicine products, the quality assurance manager of regenerative medicine products, and the safety control manager of regenerative medicine products can establish mutual coordination and cooperation among themselves and perform their services;
(vi)necessary considerations are given so that a marketing director of regenerative medicine products can fulfill the duties under Article 137-51;
(vii)respect for opinions of the marketing director of regenerative medicine products provided in Article 137-51, item (ii).
(Notification Concerning Import of Regenerative Medicine Products for Marketing)
Article 137-56(1)A holder of marketing authorization who plans to import regenerative medicine products for marketing in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the holder of marketing authorization;
(ii)the type, number, and date of marketing license;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the accreditation criteria, accreditation number, and date of accreditation of foreign manufacturers of regenerative medicine products, etc. received by the manufacturing facility prescribed in the preceding item.
(2)The notification prescribed in the preceding paragraph is to be given by submitting a notification based on Form No. 50 (the original and a duplicate).
(3)The holder of marketing authorization must submit a notification based on Form No. 51 (the original and a duplicate) to the Minister of Health, Labour and Welfare in cases where a matter included in a notification prescribed in the preceding paragraph is changed.
(Notification Concerning Import of Regenerative Medicine Products for Manufacturing)
Article 137-57(1)A manufacturer who plans to import regenerative medicine products for manufacture in the course of trade must notify the Minister of Health, Labour and Welfare about the following matters by the time of entry:
(i)the name and address of the manufacturer;
(ii)the criteria, license number, and date of license for manufacturing license;
(iii)names of items to be imported;
(iv)the name and location of the manufacturing facility of the item;
(v)the accreditation criteria, accreditation number, and date of accreditation of foreign manufacturers of regenerative medicine products, etc. received by the manufacturing facility prescribed in the preceding item.
(2)The notification prescribed in the preceding paragraph is to be made by submitting a notification based on Form No. 52 (the original and a duplicate).
(3)The manufacturer must submit a notification based on Form No. 52-2 (the original and a duplicate) to the Minister of Health, Labour and Welfare in cases where a matter included in a notification prescribed in the preceding paragraph is changed.
(Conformity of Methods to Control Manufacturing and Quality to Standards)
Article 137-58A manufacturer of regenerative medicine products or a foreign manufacturer of regenerative medicine products that have obtained accreditation prescribed in Article 23-24, paragraph (1) of the Act (hereinafter referred to as an "accredited foreign manufacturer of regenerative medicine products") must conform the methods to control manufacturing and quality at their manufacturing facility to the standards specified by Order of the Ministry of Health, Labour and Welfare provided in Article 23-25, paragraph (2), item (iv) of the Act.
(Scope of Entrusting Post-Marketing Safety Control Activities)
Article 137-59Duties specified by Order of the Ministry of Health, Labour and Welfare prescribed in Article 23-35, paragraph (3) of the Act are as follows:
(i)collection of information on matters concerning the quality, efficacy, and safety of regenerative medicine products and other information required for the appropriate use of regenerative medicine products (hereinafter referred to as the "safety management information" in this chapter);
(ii)analysis of the safety management information;
(iii)implementation of necessary measures based on results of the investigation of the safety management information;
(iv)maintaining the collected safety management information and other duties incidental to the ones set forth in the preceding three items.
(Scope of Further Entrusting Post-Marketing Safety Control Activities)
Article 137-60(1)A holder of marketing authorization for regenerative medicine products may not let a person who post-marketing safety control activities are entrusted to (hereinafter referred to as the "trustee" in this chapter) further entrust the post-marketing safety control activities.
(2)Notwithstanding the provisions of the preceding paragraph, when entrusting the post-marketing safety control activities concerning regenerative medicine products approved to be marketed integrally with medical appliances or instruments, etc. to a holder of marketing authorization for medical devices who supplies the medical appliances or instruments, etc., a holder of marketing authorization for regenerative medicine products may have the trustee further entrust the post-marketing safety control activities.
(3)A holder of marketing authorization for regenerative medicine products may not let a person to whom the post-marketing safety control activities are further entrusted pursuant to the provisions of the preceding paragraph additionally entrust the post-marketing safety control activities.
(Measures to Entrust Post-Marketing Safety Control Activities for Regenerative Medicine Products)
Article 137-61(1)When a holder of marketing authorization entrusts activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, the trustee of the activities must meet the following requirements:
(i)a person is capable of conducting entrusted activities (hereinafter referred to as "entrusted safety assurance activities" in this article) appropriately and smoothly;
(ii)a supervisor conducting the activities who is capable of implementing the entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "entrusted safety management implementation supervisor" in this Article and Article 137-63) is assigned;
(iii)a copy of the procedure manuals concerning entrusted safety assurance activities prescribed in the following paragraph and other documents required for the entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities" in this Article) is provided at an office which implements the entrusted safety assurance activities.
(2)In case of entrusting activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization must prepare operating procedures for the post-marketing safety control activities concerning entrusted safety assurance activities to state the following procedures:
(i)the procedure for collecting the safety management information;
(ii)the procedure for planning safety assurance measures based on the review of the safety management information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the entrusted safety management implementation supervisor to the safety control manager of regenerative medicine products, etc.;
(v)the procedure concerning EPPV;
(vi)the procedure for entrustment;
(vii)the procedure for maintaining records concerning entrusted safety assurance activities;
(viii)the procedure for mutual cooperation with a quality assurance manager of regenerative medicine products and other persons responsible for other operations concerning marketing regenerative medicine products;
(ix)other procedures required to appropriately and smoothly implement entrusted safety assurance activities.
(3)In case of entrusting activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization must conclude an agreement with a trustee with a document listing the following matters and maintain the agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of entrusted safety assurance activities;
(ii)matters concerning an assignment of the entrusted safety management implementation supervisor and the scope of entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph (excluding item (vi)) concerning the entrusted safety assurance activities;
(iv)matters related to instructions of implementation of entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction in prescribed paragraph (7) and the confirmation prescribed in paragraph (8);
(vii)matters related to the provision of information prescribed in paragraph (9);
(viii)other necessary matters.
(4)In cases of entrusting activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization must have a safety control manager of regenerative medicine products conduct following business operations based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph:
(i)supervising entrusted safety assurance activities;
(ii)instructing the entrusted safety management implementation supervisor in the implementation of entrusted safety assurance activities in document and maintaining copies of the documents (excluding cases where activities set forth in Article 137-59, item (i) are entrusted);
(iii)having the entrusted safety management implementation supervisor prepare records concerning entrusted safety assurance activities and report them in document;
(iv)confirming whether a trustee implements entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to a holder of marketing authorization and a marketing director of regenerative medicine products, in document.
(5)In the case of entrusting activities related to EPPV and set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization must have the safety control manager of regenerative medicine products conduct following business operations based on the operating procedures, etc. for post-marketing safety control activities and the EPPV plan:
(i)having the entrusted safety management implementation supervisor prepare records concerning entrusted safety assurance activities and report them in document;
(ii)maintaining documents in the preceding item.
(6)In cases where a trustee further entrusts activities set forth in Article 137-59, item (iv) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must have the trustee further entrust them to a person who is able to implement the further-entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with the further trustee with a document listing the following matters and maintain the agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)other necessary matters.
(7)A holder of marketing authorization must have the safety control manager of regenerative medicine products review the necessity of improvement of entrusted safety assurance activities, and if it is necessary, instruct the trustee to take required measures in document and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(8)In case of giving an instruction based on the provisions of the preceding paragraph, a holder of marketing authorization must confirm if the measures have been implemented and maintain the record.
(9)A holder of marketing authorization must provide a trustee with information necessary to implement entrusted safety assurance activities.
(Maintaining Records Concerning Entrusted Safety Assurance Activities)
Article 137-62(1)The period for maintaining documents and other records to be maintained pursuant to the provisions of the preceding Article is the one for regenerative medicine products respectively set forth in each of the items:
(i)records concerning regenerative medicine products (excluding those set forth in the following item):10 years from the day when they were no longer used;
(ii)records concerning designated regenerative medicine products:30 years from the day when they were no longer used.
(2)Notwithstanding the provisions of the preceding Article, a holder of marketing authorization may replace a person who must maintain document according to the same Article based on the operating procedures, etc. for post-marketing safety control activities or predetermined documents with a person designated by the holder of marketing authorization to have the person maintain the records.
(Measures to Further Entrust Post-Marketing Safety Control Activities for Regenerative Medicine Products)
Article 137-63(1)When a trustee further entrusts activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities for regenerative medicine product, the further trustee of the activities must meet the following requirements:
(i)a person is capable of appropriately and smoothly conducting further-entrusted activities (hereinafter referred to as "further-entrusted safety assurance activities" in this article);
(ii)a supervisor conducting the activities who is capable of implementing the further-entrusted safety assurance activities appropriately and smoothly (hereinafter referred to as the "further-entrusted safety management implementation supervisor" in this article) is assigned;
(iii)a copy of the procedure manuals prescribed in the following paragraph concerning further-entrusted safety assurance activities and other documents required for the further-entrusted safety assurance activities (hereinafter referred to as the "operating procedures, etc. for post-marketing safety control activities" in this Article) is provided at an office which implements the further-entrusted safety assurance activities.
(2)When a trustee further entrusts activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must have the trustee prepare operating procedures for post-marketing safety control activities concerning further-entrusted safety assurance activities that state the following procedures:
(i)the procedure for collecting the safety management information;
(ii)the procedure for planning safety assurance measures based on the review of the safety management information;
(iii)the procedure for implementing safety assurance measures;
(iv)the procedure for the report from the further-entrusted safety management implementation supervisor to the entrusted safety management implementation supervisor;
(v)the procedure concerning EPPV;
(vi)the procedure for further entrustment;
(vii)the procedure for maintaining records concerning further-entrusted safety assurance activities;
(viii)the procedure for a trustee's mutual cooperation with a domestic quality assurance administrator and other persons responsible for marketing regenerative medicine products operations;
(ix)other procedures required to appropriately and smoothly implement further-entrusted safety assurance activities.
(3)When a trustee further entrusts activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with a further trustee with a document listing the following matters and maintain the agreement based on the operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)matters concerning assignment of the further-entrusted safety management implementation supervisor and the scope of further-entrusted safety assurance activities implemented by the person;
(iii)matters related to procedures set forth in each of the items of the preceding paragraph (excluding item (vi)) concerning further-entrusted safety assurance activities;
(iv)matters related to instructions for implementation of further-entrusted safety assurance activities;
(v)matters related to the report prescribed in item (iii) of the following paragraph and the confirmation prescribed in item (iv) of the same paragraph;
(vi)matters related to the instruction prescribed in paragraph (7) and the confirmation prescribed in paragraph (8);
(vii)matters related to the provision of information prescribed in paragraph (9);
(viii)other necessary matters.
(4)When a trustee further entrusts activities set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must confirm that the trustee has the entrusted safety management implementation supervisor implement the following activities based on operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in the preceding paragraph:
(i)supervising further-entrusted safety assurance activities;
(ii)in case of instructing the further-entrusted safety management implementation supervisor in the implementation of further-entrusted safety assurance activities in document and maintaining copies of the writing (excluding cases where activities set forth in Article 137-59, item (i) are entrusted);
(iii)having the further-entrusted safety management implementation supervisor prepare records concerning further-entrusted safety assurance activities and report them with document;
(iv)confirming whether a further trustee implements further-entrusted safety assurance activities appropriately and smoothly and preserving the records;
(v)maintaining the reports prescribed in item (iii) and records prescribed in the preceding item as well as reporting to the trustee and the trustee's marketing director of medical devices, etc. with document.
(5)When a trustee further entrusts activities related to EPPV and set forth in Article 137-59, items (i) through (iii) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must confirm that the trustee has the entrusted safety management implementation supervisor implement the following activities based on operating procedures, etc. for post-marketing safety control activities and the EPPV plan:
(i)having the further-entrusted safety management implementation supervisor prepare records concerning further-entrusted safety assurance activities and report them in document;
(ii)maintaining documents in the preceding item.
(6)When a trustee further entrusts activities set forth in Article 137-59, item (iv) from among the post-marketing safety control activities of regenerative medicine products, a holder of marketing authorization who is the entruster must have the trustee further entrust them to a person who is able to implement the further-entrusted safety assurance activities appropriately and smoothly.In this case, a holder of marketing authorization who is the entruster must have the trustee conclude an agreement with a further trustee with a document listing the following matters and maintain the agreement based on operating procedures, etc. for post-marketing safety control activities:
(i)the scope of further-entrusted safety assurance activities;
(ii)other necessary matters.
(7)A holder of marketing authorization who is the entruster must have the trustee have the entrusted safety management implementation supervisor review the necessity of improvement of further-entrusted safety assurance activities, and if necessary, instruct the further trustee to take required measures with document and maintain the document based on the operating procedures, etc. for post-marketing safety control activities and the agreement prescribed in paragraph (3).
(8)In cases where a trustee gives instructions based on the provisions of the preceding paragraph, a holder of marketing authorization who is the entruster must have the trustee confirm if the measures have been implemented and maintain the record.
(9)A trustee must provide information necessary to implement further-entrusted safety assurance activities to a further trustee.
(Maintaining Records Concerning Further-Entrusted Safety Control Activities)
Article 137-64The provisions of Article 137-62 apply mutatis mutandis to the period for maintaining documents and other records to be maintained pursuant to the provisions of the preceding Article.In this case, "holder of marketing authorization" in Article 137-62, paragraph (2) is deemed to be replaced with "trustee".
(Notification of Changes of Marketing Directors of Regenerative Medicine Products in Marketing)
Article 137-65(1)Matters whose changes must be notified pursuant to the provisions of Article 23-36, paragraph (1) of the Act are as follows:
(i)the name and address of the holder of marketing authorization;
(ii)the name and location of the office with major functions;
(iii)if the holder of marketing authorization is a corporation, the name of the officer who is engaged in the operation;
(iv)the name and address of the marketing director of regenerative medicine products;
(v)if the holder of marketing authorization receives another type of license for marketing or abolishes the business concerning the license, the type of the license and the license number.
(2)The notification prescribed in the preceding paragraph is to be given by submitting a notification based on Form No. 6.
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to a prefectural governor who is in charge of receiving the written notifications at the time of application and other acts, if the notification has a supplementary note to that effect:
(i)a notification concerning names of holders of marketing authorization set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of a holder of marketing authorization (a certificate of registered information if the holder of marketing authorization is a corporation);
(ii)a notification concerning an officer set forth in paragraph (1), item (iii):a doctor's written diagnosis with regard to mental impairment of the new officer or whether or not the officer is addicted to narcotics, cannabis, opium, or stimulants;
(iii)a notification concerning matters set forth in paragraph (1), item (iv) (excluding in cases where a new marketing director of regenerative medicine products is a holder of marketing authorization):a copy of employment agreement and other documents proving an employment relationship between a holder of marketing authorization and a new marketing director of regenerative medicine products.
(4)The provisions of Article 16, paragraph (4) apply mutatis mutandis to a notification prescribed in paragraph (1).In this case, "prefectural governor (in the case where the location is in a city with established health centers or a special ward, the mayor of the city or the head of the special ward)" in Article 16, paragraph (4) is deemed to be replaced with "prefectural governor".
(Notification of Changes of Manufacturing Supervisors of Regenerative Medicine Products)
Article 137-66(1)Matters whose changes must be notified pursuant to the provisions of Article 23-36, paragraph (2) of the Act are as follows:
(i)the name and address of a manufacturer or a foreign manufacturer of regenerative medicine products (hereinafter referred to as a "manufacturer etc." in this Article), or a manufacturing supervisor of regenerative medicine products (a person in charge of the manufacturing facility in cases of a foreign manufacturer of regenerative medicine products; the same applies in paragraph (3), item (ii));
(ii)if the manufacturer, etc. is a corporation, the name of the officer who is engaged in the operation;
(iii)the name of the manufacturing facility;
(iv)the main parts of structure and equipment for a manufacturing facility;
(v)if the manufacturer, etc. receives another license, accreditation, or registration for manufacturing, or abolishes the manufacturing facility, the criteria and license number for the license, the criteria and accreditation number for the accreditation, or the registration number for the registration.
(2)Notification prescribed in the preceding paragraph is to be given by submitting a notification based on Form No. 6 (the original and two duplicates in case of submitting to the Minister of Health, Labour and Welfare, and the original and a duplicate in case of submitting to the Minister of Health, Labour and Welfare).
(3)Documents specified in each of the items in accordance with criteria for notifications set forth therein respectively must be attached to notifications prescribed in the preceding paragraph; provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare or the Director of the Regional Bureau of Health and Welfare, who is in charge of receiving the notifications at the time of application and other acts, or submitted to the Minister of Health, Labour and Welfare or the Director of the Regional Bureau of Health and Welfare via the prefectural governor, if the notification has a supplementary note to that effect:
(i)a notification concerning names of the manufacturer, etc. set forth in paragraph (1), item (i):a certified copy of family register, a certified copy of abridged family register, or a certificate of family register description of the manufacturer etc. (certificate of registered information if the manufacturer etc. is a corporation);
(ii)a notification concerning the name of manufacturing supervisors of regenerative medicine products set forth in paragraph (1), item (i) (excluding the case where a new manufacturing supervisor of regenerative medicine products is a manufacturer, etc.):a copy of an employment agreement or other documents proving an employment relationship between the manufacturer, etc. and a new manufacturing supervisor of regenerative medicine products;
(iii)a notification concerning an officer set forth in paragraph (1), item (ii):documents showing a new officer does not fall under Article 5, item (iii), (e) and (f) of the Act.
(Maintaining Data)
Article 137-67A person approved for regenerative medicine products must preserve data set forth in each of the following items for a period set forth in each of the same items; provided, however, that this does not apply to data in the case where it is recognized that the nature of the data makes it extremely difficult to preserve:
(i)data which the data submitted at the time of application for approval prescribed in Article 23-25, paragraph (1) or (9) of the Act is based on:five years from the date of approval (in cases of the approval with conditions and the time limit added pursuant to the provisions of Article 23-26, paragraph (1) of the Act, the date when the approval prescribed in Article 23-25, paragraph (1) of the Act for the application under Article 23-26, paragraph (5) of the Act); provided, however, that in cases of data concerning regenerative medicine products that needs reexamination prescribed in Article 23-29, paragraph (1) of the Act (limited to those whose period from the day when an approval (excluding those with conditions and the time limit prescribed in Article 23-26, paragraph (1) of the Act added) is received to the day when the reexamination is completed is more than five years), the period until the reexamination is completed;
(ii)data which the data submitted at the time of application for reexamination prescribed in Article 23-29, paragraph (1) of the Act (excluding data set forth in the preceding item) is based on:five years from the date when the reexamination of data is completed;
(iii)data which the data submitted at the time of application for reevaluation of regenerative medicine products prescribed in Article 23-31, paragraph (1) of the Act (excluding data set forth in the preceding two items) is based on:five years from the date when a reevaluation of data is completed.
(Application for Marketing Approval for Foreign-Manufactured Regenerative Medicine Products)
Article 137-68(1)An application for marketing approval for regenerative medicine products prescribed in Article 23-37, paragraph (1) of the Act is to be made by submitting a written application based on Form No. 75-17 (the original copy and two duplicates) to the Minister of Health, Labour and Welfare.
(2)The provisions in Articles 137-23 and 137-24 apply mutatis mutandis to the data that is to be attached to a written application prescribed in the preceding paragraph.
(3)The following documents must be attached to the written application prescribed in paragraph (1); provided, however, that this does not apply to documents submitted to the Minister of Health, Labour and Welfare at the time of application and other acts, if the written application has a supplementary note to that effect:
(i)if an applicant is a corporation, a document proving it is a corporation;
(ii)documents that clearly indicate whether an applicant (including officers engaged in the business operation if the applicant is a corporation) is a person provided in Article 23-37, paragraph (2) of the Act;
(iii)documents proving that a designated holder of marketing authorization for foreign-manufactured regenerative medicine products has been designated;
(iv)a copy of license certificate for marketing obtained by the designated holder of marketing authorization for foreign-manufactured regenerative medicine products;
(v)documents proving that items to be marketed by an applicant are regenerative medicine products set forth in Article 23-28, paragraph (1), item (ii) of the Act when applying for an approval prescribed in Article 23-37, paragraph (1) of the Act pursuant to the provisions of Article 23-28, paragraph (1) of the Act as applied mutatis mutandis pursuant to Article 23-40 of the Act and other necessary documents.
(Matters to Be Included in Registry of Approval for Marketing Foreign-Manufactured Regenerative Medicine Products)
Article 137-69Matters included in the registry of approval prescribed in Article 23-37, paragraph (1) of the Act and Article 23-25, paragraph (9) of the Act as applied mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act provided in Article 43-22 of the Order are to be the following matters beyond what is set forth in each of the items in Article 137-30 (excluding item (iii)):
(i)the name and address of a designated holder of marketing authorization for foreign-manufactured regenerative medicine products;
(ii)the type and license number for the marketing license obtained by the designated holder of marketing authorization for foreign-manufactured regenerative medicine products.
(Matters to Be Observed by Designated Holders of Marketing Authorization for Foreign-Manufactured Regenerative Medicine Products)
Article 137-70Matters to be observed by designated holders of marketing authorization for foreign-manufactured regenerative medicine products are as follows beyond what is set forth in each of the items of Article 137-55:
(i)matters related to activities as a designated holder of marketing authorization for foreign-manufactured regenerative medicine products are recorded and maintained for five years from the date on which the final description therein was made;
(ii)documents set forth in the following (a) to (e) are maintained for five years from the date when they were no longer used:
(a)documents giving matters for which a person with special approval for foreign-manufactured regenerative medicine products has obtained the approval;
(b)copies of data submitted at the time of application for approval prescribed in Article 23-37, paragraph (1) of the Act and Article 23-25, paragraph (9) of the Act as mutatis mutandis pursuant to Article 23-37, paragraph (5) of the Act by a person with special approval for foreign-manufactured regenerative medicine products;
(c)copies of data submitted at the time of application for reexamination prescribed in Article 23-29, paragraph (1)