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:

(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:

(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:

(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:

(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")

Article 2A license certificate for establishing a pharmacy is to be based on Form No. 2.

Article 3A pharmacy proprietor must display a license certificate for establishing a pharmacy at a readily visible place in the pharmacy.

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.

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.

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.

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:

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:

(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.

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.

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.

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

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.

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.

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.

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:

(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:

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:

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.

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.

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.

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.

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:

(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):

(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:

(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.

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.

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).

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).

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:

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.

Article 15-4A pharmacy proprietor may not put pharmaceuticals up for auction.

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.

Article 15-6In conducting specified sales, a pharmacy proprietor must conduct the same by any of the following methods:

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.

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).

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).

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.

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:

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:

(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:

(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:

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:

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:

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:

(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:

(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:

(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.

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:

(2)The notification prescribed in Article 2 of the Order is to be made by submitting a notification based on Form No. 7.

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.

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:

(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).

Article 20The license certificate for marketing pharmaceuticals, quasi-pharmaceutical products, and cosmetics is to be based on Form No. 10.

Article 21A written application prescribed in Article 5, paragraph (2) of the Order is to be based on Form No. 3.

Article 22A written application prescribed in Article 6, paragraph (2) of the Order is to be based on Form No. 4.

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.

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:

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:

(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".

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:

(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:

(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:

Article 27The license certificate for manufacturing pharmaceuticals, quasi-pharmaceutical products, and cosmetics is to be based on Form No. 13.

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.

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.

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.

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:

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:

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.

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.

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:

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:

(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:

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 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:

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.

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:

(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.

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.

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).

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):

Article 44Deletion

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.

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.

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:

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".

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:

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:

(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".

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.

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:

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.

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".

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.

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).

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

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.

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.

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".

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:

(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:

(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.

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:

(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.

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".

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.

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".

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.

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.

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:

(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.

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".

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

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:

(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:

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:

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:

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:

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).

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.

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:

(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:

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:

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

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:

(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.

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:

(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.

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:

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.

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:

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.

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:

(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:

(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:

(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:

(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"):

(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:

(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.

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".

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)".

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:

(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.

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:

(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:

(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:

(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:

(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:

(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:

(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.

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".

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".

Article 99(1)Matters whose changes must be notified pursuant to the provisions of Article 19, paragraph (1) of the Act are as follows:

(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:

(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".

Article 100(1)Matters whose changes must be notified pursuant to the provisions of Article 19, paragraph (2) of the Act are as follows:

(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:

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:

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:

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:

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:

Article 105(1)Matters for which changes must be notified pursuant to the provisions of Article 19-3 of the Act are as follows:

(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.

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.:

(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.

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.

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:

(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.

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.

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.

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.