Article 3(1)For each Site of Operations Involving Narcotics, the Minister of Health, Labour and Welfare handles the licensing of Narcotics Importers, Narcotics Exporters, Narcotics Manufacturers, Formulators of Narcotic Pharmaceuticals, Manufacturers of Exempt Narcotics, and Primary Wholesalers of Narcotics; and prefectural governors handle the licensing of Narcotics Wholesalers, Narcotics Retailers, Persons Licensed to Administer Narcotics, Narcotics Managers, and Narcotics Researchers.

(2)It is not permissible for a person other than as follows to be licensed:

(3)It is permissible not to grant licensing to a person falling under one of the following items:

Article 4(1)When licensing a Narcotics Handler pursuant to the preceding Article, the Minister of Health, Labour and Welfare or prefectural governor must issue that Narcotics Handler a license.

(2)A license must give the name and address of the Narcotics Handler and the information that Order of the Ministry of Health, Labour and Welfare prescribes.

(3)A license must not be transferred or loaned to any other person.

Article 5A Narcotics Handler's licensing is valid from the licensing date to December 31 of the year two years after that in which the licensing date falls.

Article 6A Narcotics Handler's licensing lapses at the end of its validity, if it is rescinded pursuant to Article 51, paragraph (1), or if:

Article 7(1)A Narcotics Handler must file a notification within 15 days, accompanied by its license, if, while its license is valid, it discontinues business operations or research involving Narcotics at the Site of Operations Involving Narcotics for which it has been licensed; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must file this notification and accompanying license with the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, it must file this notification and accompanying license with the prefectural governor.

(2)The provisions of the preceding paragraph apply mutatis mutandis if a Narcotics Handler comes to lack a qualification referred to in one of the items of Article 3, paragraph (2).

(3)If a Narcotics Handler dies, the heir or a person administering the estate on behalf of the heir must file a notification of this within 15 days, accompanied by the handler's license; and if a Narcotics Handler that is a corporation is dissolved, its liquidator or bankruptcy trustee, or the representative of the corporation that survives or is incorporated in a merger, must do the same; if the Narcotics Handler that dies or is dissolved is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, this notification and accompanying license must be filed with the Minister of Health, Labour and Welfare; and if the Narcotics Handler that dies or is dissolved is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, this notification and accompanying license must be filed with the prefectural governor.

Article 8At the end of the validity of licensing or if licensing is rescinded pursuant to Article 51, paragraph (1), a Narcotics Handler must return the license within 15 days; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must return its license to the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, it must return its license to the prefectural governor.

Article 9(1)If information that is specified on its license changes, a Narcotics Handler must file a notification of this within 15 days, accompanied by its license; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must file this notification and accompanying license with the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, it must file this notification and accompanying license with the prefectural governor.

(2)On receipt of a notification as referred to in the preceding paragraph, the Minister of Health, Labour and Welfare or the prefectural governor must promptly update the license and deliver it to the Narcotics Handler.

Article 10(1)If its license is damaged or lost, a Narcotics Handler must file an application for reissuance within 15 days, specifying the loss or damage as the reason and including the license, if the reason for reissuance is damage; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must file this with the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, it must file this with the prefectural governor.

(2)If, after being reissued a license pursuant to the preceding paragraph, a Narcotics Handler finds the license it had lost, it must return this within 15 days; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must return the license to the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher, it must return the license to the prefectural governor.

Article 11Deleted

Article 12(1)It is prohibited for any person to import, export, manufacture, formulate into a pharmaceutical preparation, package, transfer, accept, deliver, administer, be in possession of, or dispose of diacetylmorphine, diacetylmorphine salt, or a Narcotic containing one of these (hereinafter referred to as "Diacetylmorphine or a Similar Substance"); provided, however, that this does not apply if the operator of a Narcotics Research Facility transfers, accepts, or disposes of Diacetylmorphine or a Similar Substance with the permission of the Minister of Health, Labour and Welfare, or if a Narcotics Researcher manufactures, formulates into a pharmaceutical preparation, packages, administers, or is in possession of Diacetylmorphine or a Similar Substance for research purposes, with the permission of the Minister of Health, Labour and Welfare.

(2)It is prohibited for any person to import or export powdered opium.

(3)It is prohibited for any person to cultivate a Plant Containing a Narcotic Raw Material; provided, however, that this does not apply if a Narcotics Researcher cultivates a Plant Containing a Narcotic Raw Material for research purposes, with the permission of the Minister of Health, Labour and Welfare.

(4)It is prohibited for any person to be administered Diacetylmorphine or a Similar Substance as prohibited pursuant to paragraph (1).

Article 13(1)It is prohibited for a person that is not a Narcotics Importer to import a Narcotic (other than Diacetylmorphine or a Similar Substance or the Narcotic prescribed in paragraph (2) of the preceding Article; the same applies hereinafter in this Article through Article 19-2); provided, however, that this does not apply if persons entering Japan import a Narcotic by bringing it with them as treatment for an illness from which they suffer, with the permission of the Minister of Health, Labour and Welfare.

(2)To apply the proviso to Article 24, paragraph (1); the proviso to Article 27, paragraph (1); and the proviso to Article 28, paragraph (1); persons importing a Narcotic by carrying it on their person pursuant to the proviso to the preceding paragraph are deemed to have been delivered that Narcotic to administer by a Person Licensed to Administer Narcotics.

Article 14(1)On each occasion that a Narcotics Importer seeks to import Narcotics, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(2)A person seeking the permission referred to in the preceding paragraph must submit a written application for permission to the Minister of Health, Labour and Welfare, giving the following information:

(3)If a person that has obtained the permission referred to in paragraph (1) seeks to change a piece of information referred to in one of the items of the preceding paragraph, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(4)It is permissible for the Minister of Health, Labour and Welfare not to grant the permission referred to in paragraph (1) or the preceding paragraph upon finding it to be inappropriate to do so, considering domestic demand and stockpiles of that Narcotic.

(5)When granting the permission referred to in paragraph (1), the Minister of Health, Labour and Welfare delivers an import permit and certificate of permission for import bearing the applicant's name and address, as well as the information set forth in paragraph (2).

(6)When granting the permission referred to in paragraph (3), the Minister of Health, Labour and Welfare delivers an updated import permit and certificate of permission for import.

Article 15Having imported a Narcotic, a Narcotics Importer must submit the certificate of permission for export issued by the country of export to the Minister of Health, Labour and Welfare, within 10 days after the date of import of the Narcotic or receipt of the certificate of permission for export.

Article 16If a Narcotics Importer does not import the Narcotic within the permitted import period, it must return the import permit to the Minister of Health, Labour and Welfare within 10 days after the end of that period.

Article 17It is prohibited for a person that is not a Narcotics Exporter to export a Narcotic; provided, however, that this does not apply if persons leaving Japan export a Narcotic by bringing it with them as treatment for an illness from which they suffer, with the permission of the Minister of Health, Labour and Welfare.

Article 18(1)On each occasion that a Narcotics Exporter seeks to export Narcotics, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(2)A person seeking the permission referred to in the preceding paragraph must submit a written application for permission to the Minister of Health, Labour and Welfare giving the following information, accompanied by a certificate of permission for import issued by the country of import:

(3)If a person that has obtained the permission referred to in paragraph (1) seeks to change a piece of information referred to in one of the items of the preceding paragraph, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(4)When granting the permission referred to in paragraph (1), the Minister of Health, Labour and Welfare delivers an export permit and certificate of permission for export bearing the applicant's name and address, as well as the information set forth in the items of paragraph (2).

(5)When granting the permission referred to in paragraph (3), the Minister of Health, Labour and Welfare delivers an updated export permit and certificate of permission for export.

(6)When exporting a Narcotic, a Narcotics Exporter must send the certificate of permission for export along with that Narcotic.

Article 19If a Narcotics Exporter does not export the Narcotic within the permitted export period, it must return the export permit and certificate of permission for export to the Minister of Health, Labour and Welfare within 10 days after the end of that period.

Article 19-2When exporting a Narcotic, a Narcotics Exporter must not give a false indication as regards the product name and quantity.

Article 20(1)It is prohibited for a person that is not a Narcotics Manufacturer to manufacture a Narcotic (other than Diacetylmorphine or a Similar Substance; the same applies hereinafter in this Section other than in Article 29-2); provided, however, that this does not apply if a Narcotics Researcher manufactures Narcotics for research purposes.

(2)It is prohibited for a person that is not a Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, or Manufacturer of Exempt Narcotics to manufacture an Exempt Narcotic; provided, however, that this does not apply if a Narcotics Researcher manufactures Narcotics for research purposes.

Article 21(1)Before manufacturing a Narcotic or Exempt Narcotic, a Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, or Manufacturer of Exempt Narcotics must obtain the permission of the Minister of Health, Labour and Welfare for the product name and quantity of the Narcotics or Exempt Narcotics it seeks to manufacture, as well as for the product name and quantity of any Narcotics, Opium, or Opium Poppy it would use to manufacture them, for each of the periods from January through June and from July through December (hereinafter referred to as a "Semiannual Period").

(2)The provisions of Article 14, paragraph (4) apply mutatis mutandis to the permission referred to in the preceding paragraph.

(3)On finding it to be necessary to do so when granting the permission referred to in paragraph (1), the Minister of Health, Labour and Welfare may designate the capacity of containers into which the Narcotic being manufactured must be placed.

Article 22It is prohibited for a person that is not a Narcotics Manufacturer or a Formulator of Narcotic Pharmaceuticals to formulate a pharmaceutical preparation of Narcotics or to package a Narcotic; provided, however, that this does not apply if a Narcotics Researcher formulates a pharmaceutical preparation of a Narcotic or packages it for research purposes.

Article 23(1)Before formulating a pharmaceutical preparation of Narcotics or packaging them, a Narcotics Manufacturer or Formulator of Narcotic Pharmaceuticals must obtain the permission of the Minister of Health, Labour and Welfare for the product name and quantity of the Narcotics it seeks to formulate pharmaceutical preparations of or package, as well as for the product name and quantity of Narcotics it would use to formulate pharmaceutical preparations of them, for each Semiannual Period.

(2)The provisions of Article 14, paragraph (4) and Article 21, paragraph (3) apply mutatis mutandis to the permission referred to in the preceding paragraph.

Article 24(1)It is prohibited for a person that is not a Commercial Narcotics Handler to transfer a Narcotic; provided, however, that this does not apply if:

(2)The proviso to the preceding paragraph does not apply if a Narcotic that is delivered to a person to administer is delivered in violation of Article 27, paragraph (1), (3), or (4), nor does it apply if a Narcotics Prescription is delivered in violation of paragraph (3) or (4) of that Article.

(3)A Narcotics Importer must not transfer a Narcotic to a person other than a Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Primary Wholesaler of Narcotics, or Narcotics Wholesaler; provided, however, that this does not apply to the transfer of codeine, dihydrocodeine, or the salts of either of these to a Manufacturer of Exempt Narcotics.

(4)A Narcotics Exporter must not transfer Narcotics except when exporting them.

(5)A Narcotics Manufacturer must not transfer a Narcotic to a person other than a Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Primary Wholesaler of Narcotics, or Narcotics Wholesaler; provided, however, that this does not apply to the transfer of codeine, dihydrocodeine, or the salts of either of these to a Manufacturer of Exempt Narcotics.

(6)A Formulator of Narcotic Pharmaceuticals must not transfer a Narcotic to a person other than a Narcotics Exporter, Formulator of Narcotic Pharmaceuticals, Primary Wholesaler of Narcotics, or Narcotics Wholesaler.

(7)A Manufacturer of Exempt Narcotics must not transfer Narcotics.

(8)A Primary Wholesaler of Narcotics must not transfer a Narcotic to a person other than a Primary Wholesaler of Narcotics or Narcotics Wholesaler.

(9)A Narcotics Wholesaler must not transfer a Narcotic to a person other than a Narcotics Wholesaler, Narcotics Retailer, operator of a Medical Facility at Which Narcotics Are Administered, or operator of a Narcotics Research Facility within the boundaries of the prefecture containing the locality of the Site of Operations Involving Narcotics for which it has been granted its license.

(10)The provisions of the preceding paragraphs do not apply if Narcotics are transferred with the permission of the Minister of Health, Labour and Welfare.

(11)A Narcotics Retailer must not transfer a Narcotic other than to a person in possession of a Narcotics Prescription (excluding one that has been delivered in violation of Article 27, paragraph (3) or (4)).

(12)The provisions of the preceding paragraph do not apply if Narcotics are transferred with the permission of the person prescribed in one of the following items, in the category of case set forth in that item:

Article 25When transferring a Narcotic to a person in possession of a Narcotics Prescription, a Narcotics Retailer must not transfer a Narcotic other than the one dispensed based on that prescription.

Article 26(1)It is prohibited for a person that is not a Commercial Narcotics Handler, owner of a Medical Facility at Which Narcotics Are Administered, or owner of a Narcotics Research Facility to accept a Narcotic; provided, however, that this does not apply if:

(2)The proviso to the preceding paragraph does not apply if the Narcotic delivered by the Person Licensed to Administer Narcotics is delivered in violation of paragraph (3) or (4) of the following Article or if the Narcotics Prescription is delivered in violation of those provisions.

(3)A Commercial Narcotics Handler, operator of a Medical Facility at Which Narcotics Are Administered, or operator of a Narcotics Research Facility must not become the other party to a transfer of Narcotics that is prohibited pursuant to Article 24.

Article 27(1)It is prohibited for a person that is not a Person Licensed to Administer Narcotics to administer a Narcotic, deliver a person a Narcotic to administer, or deliver a prescription for a Narcotic; provided, however, that this does not apply if:

(2)The proviso to the preceding paragraph does not apply if either the Narcotic delivered by the Person Licensed to Administer Narcotics or the Narcotics Prescription is delivered or delivered in violation of paragraph (3) or (4).

(3)A Person Licensed to Administer Narcotics must not administer a Narcotic, deliver a person a Narcotic to administer, or deliver a prescription for a Narcotic for any other purpose than as treatment for an illness; provided, however, that this does not apply if a mental health doctor dispenses N-allylnormorphine, its salts, a Narcotic that contains either of these, or a Narcotic that Cabinet Order prescribes, in order to conduct a medical examination under Article 58-6, paragraph (1).

(4)Notwithstanding the preceding paragraph, a Person Licensed to Administer Narcotics must not administer a Narcotic, deliver a person a Narcotic to administer, or deliver a prescription for a Narcotic to alleviate the symptoms of addiction in a person addicted to Narcotics or Opium or to otherwise treat the addiction; provided, however, that this does not apply if a Person Licensed to Administer Narcotics providing medical treatment at a hospital that Order of the Ministry of Health, Labour and Welfare prescribes under Article 58-8, paragraph (1) administers 6-dimethylamino-4,4-diphenyl-3-heptanone, its salts, a Narcotic that contains either of these, or a Narcotic that Cabinet Order prescribes to a person hospitalized in that hospital pursuant to that Article.

(5)It is prohibited for any person to be administered a Narcotic as prohibited pursuant to paragraph (1), (3), or (4).

(6)When issuing a prescription for a Narcotic, a Person Licensed to Administer Narcotics must write the name of the patient (or, if the patient is an animal, the type of animal and the name of its owner or handler) and the product name, quantity, usage, and dosage of the Narcotic, the name and license number of the Person Licensed to Administer Narcotics, and the information that Order of the Ministry of Health, Labour and Welfare prescribes, on a prescription sheet that bears either the name and seal or the signature of that person.

Article 28(1)It is prohibited for any person that is not a Narcotics Handler, the owner of a Medical Facility at Which Narcotics Are Administered, or the owner of a Narcotics Research Facility to have possession of a Narcotic; provided, however, that this does not apply if:

(2)The proviso to the preceding paragraph does not apply if the Narcotic that is delivered or Narcotics Prescription that is delivered by the Person Licensed to Administer Narcotics is delivered in violation of paragraph (3) or (4) of the preceding Article.

(3)A Manufacturer of Exempt Narcotics must not have possession of a Narcotic other than codeine, dihydrocodeine, or their salts.

Article 29A person seeking to dispose of a Narcotic must file a notification with the prefectural governor giving the product name and quantity of the Narcotic as well as the means of disposal, and must dispose of it in the presence of a prefectural official; provided, however, that this does not apply if a Narcotics Retailer or the operator of a Medical Facility at Which Narcotics Are Administered disposes of a Narcotic that has been dispensed based on a Narcotics Prescription pursuant to Order of the Ministry of Health, Labour and Welfare.

Article 29-2It is prohibited for any person to advertise a Narcotic other than in a newspaper or journal for medical and pharmaceutical specialists or researchers (meaning medical and pharmaceutical specialists or persons engaged in research in the natural sciences; the same applies hereinafter in this Article) which prints articles about medicine, pharmaceuticals, or the natural sciences, or in a way that otherwise primarily targets medical and pharmaceutical specialists or researchers.

Article 30(1)When a Narcotics Importer, Narcotics Manufacturer, or Formulator of Narcotic Pharmaceuticals transfers Narcotics it has imported, manufactured, formulated into a pharmaceutical preparation, or packaged, it must seal the container into which it has placed the Narcotics or the container's immediate wrapper with a certification sticker issued by the government, pursuant to Order of the Ministry of Health, Labour and Welfare.

(2)A Commercial Narcotics Handler (other than a Narcotics Retailer) must not transfer a Narcotic unless it remains sealed pursuant to the preceding paragraph.

(3)It is prohibited for a Person Licensed to Administer Narcotics or Narcotics Retailer to deliver or transfer a Narcotic that remains sealed pursuant to paragraph (1).

(4)The provisions of the preceding three paragraphs do not apply if a Narcotic is transferred with the permission under Article 24, paragraph (10) or (12).

Article 31A Commercial Narcotics Handler (other than a Narcotics Retailer) must not transfer a Narcotic other than one bearing the mark "((麻))" (an abbreviation of the word "narcotic", which is pronounced "ma") and the following information on its container and the packaging directly surrounding that container; provided, however, that this does not apply if it is transferring a Narcotic with the permission under Article 24, paragraph (10):

Article 32(1)When transferring a Narcotic, a Commercial Narcotics Handler (other than a Narcotics Retailer; the same applies in the following paragraph) must not deliver the Narcotic until after receiving from the acquirer a proof of acquisition that the acquirer has prepared pursuant to Order of the Ministry of Health, Labour and Welfare, or unless it delivers the Narcotic in exchange for the proof of acquisition; and when delivering a Narcotic, a Commercial Narcotics Handler must deliver the acquirer of the Narcotic a proof of transfer prepared pursuant to Order of the Ministry of Health, Labour and Welfare at the same time; provided, however, that this does not apply if it is transferring a Narcotic with the permission under Article 24, paragraph (10).

(2)With the consent of the acquirer and pursuant to Cabinet Order, in lieu of being delivered proof of acquisition under the preceding paragraph, a Commercial Narcotics Handler as referred to in that paragraph may be provided with the information that is required to be given in the proof of acquisition through one of the means of employing an electronic data processing system or otherwise making use of information communication technology which Order of the Ministry of Health, Labour and Welfare prescribes. In that case, a Commercial Narcotics Handler is deemed to have received proof of acquisition.

(3)The proof of acquisition or proof of transfer as referred to in paragraph (1), or, if the means prescribed in the first clause of the preceding paragraph are used, the electronic or magnetic record that is created using those means (meaning a record created in electronic form, magnetic form, or any other form that cannot be perceived by the human senses, which Order of the Ministry of Health, Labour and Welfare prescribes as being put to use in computerized data processing), must be kept on file with the recipient for two years, beginning on the date of its receipt.

Article 33(1)The operator of a Medical Facility at Which Narcotics Are Administered that has two or more Persons Licensed to Administer Narcotics providing medical treatment must have one Narcotics Manager; provided, however, that this does not apply if the operator is a Narcotics Manager.

(2)A Narcotics Manager (or a Person Licensed to Administer Narcotics at a Medical Facility at Which Narcotics Are Administered without a Narcotics Manager; hereinafter the same applies in this Section and the following Section) must manage the Narcotics that are administered or delivered to persons to administer at the Medical Facility at Which Narcotics Are Administered; and a Narcotics Researcher must manage the Narcotics that the researcher personally uses for research at the Narcotics Research Facility.

(3)A Person Licensed to Administer Narcotics must not administer a Narcotic or deliver a person a Narcotic to administer at a Medical Facility at Which Narcotics Are Administered if it is other than one of the Narcotics that the Narcotics Manager manages pursuant to the preceding paragraph.

Article 34(1)Narcotics Handlers must act as custodians of the Narcotics that are under their ownership or under their management, within their Sites of Operations Involving Narcotics.

(2)Custody as referred to in the preceding paragraph must be implemented through the segregation of Narcotics from non-narcotic pharmaceuticals (other than stimulant drugs) and through their storage under lock and key in an impregnable installation.

Article 35(1)If a Narcotic under the ownership or management of a Narcotics Handler is destroyed or stolen, if it becomes unclear where the Narcotic is located, or if any other incident occurs involving the Narcotic, the Narcotics Handler must promptly file a notification giving the product name and quantity of the Narcotic and the necessary information to clarify the circumstances of the incident; if the Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must file this notification with the Minister of Health, Labour and Welfare; and if the Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, Person Licensed to Administer Narcotics, Narcotics Manager, or Narcotics Researcher it must file this notification with the prefectural governor.

(2)Having disposed of a Narcotic that has been dispensed based on a Narcotics Prescription pursuant to the proviso to Article 29, a Narcotics Retailer or the operator of a Medical Facility at Which Narcotics Are Administered must file a notification with the prefectural governor within 30 days, giving the product name and quantity of the Narcotic and the information that Order of the Ministry of Health, Labour and Welfare prescribes.

(3)Having received a notification as referred to in paragraph (1), a prefectural governor must promptly report this to the Minister of Health, Labour and Welfare.

Article 36(1)If the licensing of a Commercial Narcotics Handler lapses, or if a Medical Facility at Which Narcotics Are Administered or Narcotics Research Facility comes to no longer be a Medical Facility at Which Narcotics Are Administered or Narcotics Research Facility (other than if a Commercial Narcotics Handler becomes a Commercial Narcotics Handler, in continuation, after the lapse of its licensing), the Commercial Narcotics Handler, the operator of the Medical Facility at Which Narcotics Are Administered, or the operator of the Narcotics Research Facility must file a notification of the product names and quantities of Narcotics currently under its ownership within 15 days; if the Commercial Narcotics Handler is a Narcotics Importer, Narcotics Exporter, Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, Manufacturer of Exempt Narcotics, or Primary Wholesaler of Narcotics, it must file this with the Minister of Health, Labour and Welfare; and if the Commercial Narcotics Handler is a Narcotics Wholesaler, Narcotics Retailer, the operator of a Medical Facility at Which Narcotics Are Administered, or the operator of a Narcotics Research Facility, it must file this with the prefectural governor.

(2)Article 12, paragraph (1); Article 24, paragraph (1); and Article 26, paragraph (3) do not apply to the transfer or acquisition of Narcotics as referred to in the preceding paragraph, but only if the person that must file the notification pursuant to that paragraph transfers those Narcotics to a Commercial Narcotics Handler, the operator of a Medical Facility at Which Narcotics Are Administered or the operator of a Narcotics Research Facility (if the Narcotic referred to in that paragraph is Diacetylmorphine or a Similar Substance, this is limited to a transfer to the operator of a Narcotics Research Facility) within 50 days after the day that the reason to file the notification occurs (if the person is a Narcotics Wholesaler, Narcotics Retailer, the operator of a Medical Facility at Which Narcotics Are Administered, or the operator of a Narcotics Research Facility, this is limited to the person's transfer of those Narcotics to a Commercial Narcotics Handler, operator of a Medical Facility at Which Narcotics Are Administered, or operator of a Narcotics Research Facility that is located within the boundaries of the prefecture containing the locality of the Site of Operations Involving Narcotics for which the person's licensing has lapsed); and Article 12, paragraph (1) and Article 28, paragraph (1) do not apply to that person's possession of Narcotics as referred to in that paragraph, but only during that 50-day period.

(3)A person transferring Narcotics within the period referred to in the preceding paragraph must file a notification with either the Minister of Health, Labour and Welfare or the prefectural governor, in accordance with the classification provided for in paragraph (1), giving the product name and quantity of the Narcotics, the date of the transfer, and the name and address of the acquirer, within 15 days after the date of the transfer.

(4)Paragraph (1) and the preceding paragraph apply mutatis mutandis to the heir or person administering the estate on behalf of the heir if a Commercial Narcotics Handler, the operator of a Medical Facility at Which Narcotics Are Administered, or the operator of a Narcotics Research Facility dies; and also apply to the liquidator or bankruptcy trustee, or the representative of the corporation that survives or is incorporated in a merger, if a Commercial Narcotics Handler, the operator of a Medical Facility at Which Narcotics Are Administered, or the operator of a Narcotics Research Facility is a corporation and is dissolved; and paragraph (2) applies mutatis mutandis to a transfer and acquisition if the heir, person administering the estate, liquidator, bankruptcy trustee, or representative transfers Narcotics, as well as to the relevant person's possession of Narcotics.

Article 37(1)A Commercial Narcotics Handler (other than a Narcotics Retailer) must keep books at its Sites of Operations Involving Narcotics and enter the following information in them:

(2)A Commercial Narcotics Handler (other than a Narcotics Retailer) must keep the books referred to in the preceding paragraph on file for two years after the date of the last entry (if it is a Narcotics Manufacturer, this includes entries under Article 39, paragraph (1) of the Opium Control Act).

Article 38(1)A Narcotics Retailer must keep books at its Sites of Operations Involving Narcotics and must enter the following information in them:

(2)A Narcotics Retailer must keep the books referred to in the preceding paragraph on file for two years after the date of the last entry.

Article 39(1)A Narcotics Manager must keep books at the Medical Facility at Which Narcotics Are Administered and must enter the following information in them:

(2)Having closed the books referred to in the preceding paragraph, a Narcotics Manager must promptly deliver them to the operator of the Medical Facility at Which Narcotics Are Administered.

(3)Having been delivered books pursuant to the preceding paragraph, the operator of a Medical Facility at Which Narcotics Are Administered must keep them on file for two years after the last entry.

Article 40(1)A Narcotics Researcher must keep books at the Narcotics Research Facility and enter the following information in them:

(2)Having closed the books referred to in the preceding paragraph, a Narcotics Researcher must promptly deliver them to the operator of the Narcotics Research Facility.

(3)Having been delivered books pursuant to the preceding paragraph, the operator of a Narcotics Research Facility must keep them on file for two years after the last entry (this includes entries under Article 39, paragraph (2) of the Opium Control Act).

Article 41Having administered a Narcotic or delivered a person a Narcotic to administer, a Person Licensed to Administer Narcotics must enter the name and address of the patient (or, if the patient is an animal, the type of animal and the name of its owner or handler), the name of the illness, its primary symptoms, the product name, and the quantity of Narcotics administered or delivered to a person to administer, as well as the date it was administered or delivered to that person, in a medical record as provided in Article 24 of the Medical Practitioners' Act or Article 23 of the Dental Practitioners' Act (Act No. 202 of 1948) or in a medical report as provided in Article 21 the Veterinarians Act (Act No. 186 of 1949).

Article 42Within 15 days after the end of each Semiannual Period, a Narcotics Importer must file a notification with the Minister of Health, Labour and Welfare giving the following information:

Article 43Within 15 days after the end of each Semiannual Period, a Narcotics Exporter must file a notification with the Minister of Health, Labour and Welfare giving the following information:

Article 44Within 15 days after the end of each Semiannual Period, a Narcotics Manufacturer, Formulator of Narcotic Pharmaceuticals, or Manufacturer of Exempt Narcotics must file a notification with the Minister of Health, Labour and Welfare giving the following information:

Article 45Within 15 days after the end of each Semiannual Period, a Primary Wholesaler of Narcotics must file a notification with the Minister of Health, Labour and Welfare giving the following information:

Article 46(1)Within 15 days after the end of each Semiannual Period, a Narcotics Wholesaler must file a notification with the prefectural governor giving the information set forth in the items of the preceding Article.

(2)A prefectural governor must compile the notifications referred to in the preceding paragraph and file a report with the Minister of Health, Labour and Welfare within 50 days after the end of that period.

Article 47A Narcotics Retailer must file a notification with the prefectural governor giving the following information no later than November 30 of each year:

Article 48A Narcotics Manager must file a notification with the prefectural governor giving the following information no later than November 30 of each year:

Article 49A Narcotics Researcher must file a notification with the prefectural governor giving the following information no later than November 30 of each year:

Article 50(1)For each Commercial Establishment at Which Psychotropics Are Handled, the Minister of Health, Labour and Welfare handles the licensing of Psychotropics Importers, Psychotropics Exporters, Psychotropics Manufacturers, Formulators of Psychotropic Pharmaceuticals, and Psychotropics Processors; and prefectural governors handle the licensing of Psychotropics Wholesalers and Psychotropics Retailers.

(2)It is permissible not to grant licensing to a person if:

Article 50-2The licensing of a Psychotropics Importer, Psychotropics Exporter, Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals, or Psychotropics Processor is valid for five years after the licensing date, and the licensing of a Psychotropics Wholesaler or Psychotropics Retailer is valid for six years after the licensing date.

Article 50-3The licensing of a Commercial Psychotropics Handler lapses at the end of its validity, if it is rescinded pursuant to Article 51, paragraph (2), or if it files the notification referred to in Article 7, paragraph (1) as applied mutandis pursuant to the following Article.

Article 50-4The provisions of Article 4; Article 7, paragraphs (1) and (3); and Articles 8 through 10 apply mutatis mutandis to a Commercial Psychotropics Handler. In that case, the phrase "15 days" in Article 7, paragraph (1) and (3) and in Articles 8 through 10 is deemed to be replaced with "30 days", and Cabinet Order provides for any other necessary technical replacement of terms in these provisions.

Article 50-5(1)The Minister of Health, Labour and Welfare handles the registration of Operators of Facilities Conducting Experiments or Research Involving Psychotropics for each Facility Conducting Experiments or Research Involving Psychotropics that is operated by the national government; and the prefectural governor handles the registration of Operators of Facilities Conducting Experiments or Research Involving Psychotropics for each other Facility Conducting Experiments or Research Involving Psychotropics.

(2)It is permissible for the Minister of Health, Labour and Welfare or the prefectural governor not to register a person whose registration has been rescinded pursuant to Article 51, paragraph (3), if three years have not passed since the date of the rescission.

Article 50-6The registration of the Operator of a Facility Conducting Experiments or Research Involving Psychotropics lapses if rescinded pursuant to Article 51, paragraph (3), or if it files the notification referred to in Article 7, paragraph (1) as applied mutandis pursuant to the following Article.

Article 50-7The provisions of Article 4; Article 7, paragraph (1) and (3); and Articles 8 through 10 apply mutatis mutandis to the Operator of a Facility Conducting Experiments or Research Involving Psychotropics. In that case, the phrase "15 days" in Article 7, paragraph (1) and (3) and in Articles 8 through 10 is deemed to be replaced with "30 days", and Cabinet Order provides for any other necessary technical replacement of the terms in these provisions.

Article 50-8It is prohibited for a person other than as follows to import a Psychotropic:

Article 50-9(1)On each occasion that a Psychotropics Importer seeks to import a Psychotropic that Cabinet Order prescribes (hereinafter referred to as a "Type I Psychotropic"), it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(2)On each occasion that a person set forth in item (iii) or (iv) of the preceding Article seeks to import a Psychotropic, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(3)The provisions of Article 14, paragraphs (2), (3), (5), and (6) and Articles 15 and 16 apply mutatis mutandis to a person seeking to import a Type I Psychotropic with the permission referred to in the preceding two paragraphs. In that case, in Article 14, paragraph (2), the phrase "the preceding paragraph" is deemed to be replaced with "Article 50-9, paragraph (1) or (2)" and the term "Narcotic" is deemed to be replaced with "Type I Psychotropic"; in Article 14, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (1) or (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of paragraph (2) of Article 14 as applied mutandis pursuant to Article 50-9, paragraph (3)"; in Article 14, paragraph (5), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (1) or (2)" and the phrase "paragraph (2)" is deemed to be replaced with "Article 14, paragraph (2) as applied mutandis pursuant to Article 50-9, paragraph (3)"; in Article 14, paragraph (6), the phrase "paragraph (3)" is deemed to be replaced with "Article 14, paragraph (3) as applied mutandis pursuant to Article 50-9, paragraph (3)"; and in Articles 15 and 16, the term "Narcotics Importer" is deemed to be replaced with "Psychotropics Importer or a person set forth in item (iii) or (iv) of Article 50-8" and the term "Narcotic" is deemed to be replaced with "Type I Psychotropic".

(4)The provisions of Article 14, paragraphs (2), (3), (5), and (6) and Articles 15 and 16 apply mutatis mutandis to a person seeking to import a Psychotropic that Cabinet Order prescribes, with the permission referred to in paragraph (2) (hereinafter referred to as a "Type II Psychotropic"). In that case, in Article 14, paragraph (2), the phrase "the preceding paragraph" is deemed to be replaced with "Article 50-9, paragraph (2)" and the term "Narcotic" is deemed to be replaced with "Type II Psychotropic"; in Article 14, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of paragraph (2) of Article 14 as applied mutandis pursuant to Article 50-9, paragraph (4)"; in Article 14, paragraph (5), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (2)", the phrase "paragraph (2)" is deemed to be replaced with "Article 14, paragraph (2) as applied mutandis pursuant to Article 50-9, paragraph (4)", and the phrase "import permit and certificate of permission for import" is deemed to be replaced with "import permit"; in Article 14, paragraph (6), the phrase "paragraph (3)" is deemed to be replaced with "Article 14, paragraph (3) as applied mutandis pursuant to Article 50-9, paragraph (4)" and the phrase "import permit and certificate of permission for import" is deemed to be replaced with "import permit"; in Article 15, the term "Narcotics Importer" is deemed to be replaced with "person set forth in item (iii) or (iv) of Article 50-8", the term "Narcotic" is deemed to be replaced with "Type II Psychotropic", the phrase "certificate of permission for export issued by the country of export" is deemed to be replaced with "export notification prepared by the exporter (or a certificate of permission for export, if the country of export issues the certificate; the same applies hereinafter in this Article)", and the phrase "or received the certificate of permission for export" is deemed to be replaced with "or received the export notification"; and in Article 16, the term "Narcotics Importer" is deemed to be replaced with "person set forth in item (iii) or (iv) of Article 50-8" and the term "Narcotic" is deemed to be replaced with "Type II Psychotropic".

(5)The provisions of Article 14, paragraphs (2), (3), (5), and (6) and Article 16 apply mutatis mutandis to a person seeking to import a Psychotropic other than a Type I Psychotropic or Type II Psychotropic, with the permission referred to in paragraph (2) (hereinafter referred to as a "Type III Psychotropic"). In that case, in Article 14, paragraph (2), the phrase "the preceding paragraph" is deemed to be replaced with "Article 50-9, paragraph (2)" and the term "Narcotic" is deemed to be replaced with "Type III Psychotropic"; in Article 14, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of paragraph (2) of Article 14 as applied mutandis pursuant to Article 50-9, paragraph (5)"; in Article 14, paragraph (5), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-9, paragraph (2)", the phrase "paragraph (2)" is deemed to be replaced with "Article 14, paragraph (2) as applied mutandis pursuant to Article 50-9, paragraph (5)", and the phrase "import permit and certificate of permission for import" is deemed to be replaced with "import permit"; in Article 14, paragraph (6), the phrase "paragraph (3)" is deemed to be replaced with "Article 14, paragraph (3) as applied mutandis pursuant to Article 50-9, paragraph (5)" and the phrase "import permit and certificate of permission for import" is deemed to be replaced with "import permit"; and in Article 16, the term "Narcotics Importer" is deemed to be replaced with "person set forth in item (iii) or (iv) of Article 50-8" and the term "Narcotic" is deemed to be replaced with "Type III Psychotropic".

Article 50-10Having imported a Type II Psychotropic, a Psychotropics Importer must submit the export notification prepared by the exporter (or a certificate of permission for export, if the country of export issues the certificate; the same applies hereinafter in this Article) to the Minister of Health, Labour and Welfare, within 10 days after the date of the import of the Psychotropic or receipt of the export notification.

Article 50-11It is prohibited for a person other than as follows to export a Psychotropic:

Article 50-12(1)On each occasion that a Psychotropics Exporter seeks to export a Type I Psychotropic, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(2)On each occasion that a person set forth in item (iii) or (iv) of the preceding Article seeks to export a Psychotropic, it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(3)The provisions of Article 18, paragraphs (2) through (6) and Article 19 apply mutatis mutandis to a person seeking to export Type I Psychotropics with the permission referred to in the preceding two paragraphs. In that case, in Article 18, paragraph (2), the phrase "preceding paragraph" is deemed to be replaced with "Article 50-12, paragraph (1) or (2)", the word "information" is deemed to be replaced with "information and the destination", and the term "Narcotic" is deemed to be replaced with "Type I Psychotropic"; in Article 18, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (1) or (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (3)"; in Article 18, paragraph (4), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (1) or (2)" and the phrase "the items of paragraph (2)" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (3)"; in Article 18, paragraph (5), the phrase "paragraph (3)" is deemed to be replaced with "Article 18, paragraph (3) as applied mutandis pursuant to Article 50-12, paragraph (3)"; and in Article 14, paragraph (6) and Article 19, the term "Narcotics Exporter" is deemed to be replaced with "Psychotropics Exporter or a person set forth in item (iii) or (iv) of Article 50-11" and the term "Narcotic" is deemed to be replaced with "Type I Psychotropic".

(4)The provisions of Article 18, paragraphs (2) through (6) and Article 19 apply mutatis mutandis to persons seeking to export Type II Psychotropics with the permission referred to in paragraph (2). In that case, in Article 18, paragraph (2), the phrase "preceding paragraph" is deemed to be replaced with "Article 50-12, paragraph (2)" the word "information" is deemed to be replaced with "information and the destination", the phrase "accompanied by a certificate of permission for import issued by the country of import" is deemed to be deleted, and the term "Narcotic" is deemed to be replaced with "Type II Psychotropic"; in Article 18, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (4)"; in Article 18, paragraph (4), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (2)" and the phrase "the items of paragraph (2)" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (4)"; in Article 18, paragraph (5), the phrase "paragraph (3)" is deemed to be replaced with "Article 18, paragraph (3) as applied mutandis pursuant to Article 50-12, paragraph (4)"; and in Article 14, paragraph (6) and Article 19, the term "Narcotics Exporter" is deemed to be replaced with "a person set forth in item (iii) or (iv) of Article 50-11" and the term "Narcotic" is deemed to be replaced with "Type II Psychotropic".

(5)The provisions of Article 18, paragraphs (2) through (5) and Article 19 apply mutatis mutandis to a person seeking to export Type III Psychotropics with the permission referred to in paragraph (2). In that case, in Article 18, paragraph (2), the phrase "preceding paragraph" is deemed to be replaced with "Article 50-12, paragraph (2)" the word "information" is deemed to be replaced with "information and the destination", the phrase "accompanied by a certificate of permission for import issued by the country of import" is deemed to be deleted, and the term "Narcotic" is deemed to be replaced with "Type III Psychotropic"; in Article 18, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (2)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (5)"; in Article 18, paragraph (4), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-12, paragraph (2)" the phrase "the items of paragraph (2)" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-12, paragraph (5)" and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit"; in Article 18, paragraph (5), the phrase "paragraph (3)" is deemed to be replaced with "Article 18, paragraph (3) as applied mutandis pursuant to Article 50-12, paragraph (5)" and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit"; and in Article 19, the term "Narcotics Exporter" is deemed to be replaced with "a person set forth in item (iii) or (iv) of Article 50-11", the term "Narcotic" is deemed to be replaced with "Type III Psychotropic", and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit".

Article 50-13(1)On each occasion that a Psychotropics Exporter seeks to export a Psychotropic that Cabinet Order prescribes (hereinafter referred to as a "specified psychotropic" in this Article and the following Article) and that constitutes a Type II Psychotropic (referred to as a "specified type II psychotropic" in the following paragraph) or to export a specified psychotropic that constitutes a Type III Psychotropic (referred to as "specified type III psychotropic" in paragraph (3)), to a destination in a region that Cabinet Order prescribes (hereinafter referred to as a "specified region" in this Article and the following Article), it must obtain the permission of the Minister of Health, Labour and Welfare to do so.

(2)The provisions of Article 18, paragraphs (2) through (6) and Article 19 apply mutatis mutandis to a person seeking to export a specified type II psychotropic to a destination in a specified region, with the permission referred to in the preceding paragraph. In that case, in Article 18, paragraph (2), the phrase "preceding paragraph" is deemed to be replaced with "Article 50-13, paragraph (1)" the word "information" is deemed to be replaced with "information and the destination", the phrase "accompanied by a certificate of permission for import issued by the country of import" is deemed to be deleted, and the term "Narcotic" is deemed to be replaced with "specified type II psychotropic"; in Article 18, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-13, paragraph (1)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-13, paragraph (2)"; in Article 18, paragraph (4), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-13, paragraph (1)" and the phrase "the items of paragraph (2)" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-13, paragraph (2)"; in Article 18, paragraph (5), the phrase "paragraph (3)" is deemed to be replaced with "Article 18, paragraph (3) as applied mutandis pursuant to Article 50-13, paragraph (2)"; and in Article 14, paragraph (6) and Article 19, the term "Narcotics Exporter" is deemed to be replaced with "Psychotropics Exporter" and the term "Narcotic" is deemed to be replaced with "specific type II psychotropic".

(3)The provisions of Article 18, paragraphs (2) through (5) and Article 19 apply mutatis mutandis to a person seeking to export a specified type III psychotropic to a destination in a specified region, with permission under paragraph (1). In that case, in Article 18, paragraph (2), the phrase "the preceding paragraph" is deemed to be replaced with "Article 50-13, paragraph (1)", the word "information" is deemed to be replaced with "information and the destination", the phrase "accompanied by a certificate of permission for import issued by the country of import" is deemed to be deleted, and the term "Narcotic" is deemed to be replaced with "specified type III psychotropic"; in Article 18, paragraph (3), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-13, paragraph (1)" and the phrase "the items of the preceding paragraph" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-13, paragraph (3)"; in Article 18, paragraph (4), the phrase "paragraph (1)" is deemed to be replaced with "Article 50-13, paragraph (1)", the phrase "the items of paragraph (2)" is deemed to be replaced with "the items of Article 18, paragraph (2) as applied mutandis pursuant to Article 50-13, paragraph (3)", and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit"; in Article 18, paragraph (5), the phrase "paragraph (3)" is deemed to be replaced with "Article 18, paragraph (3) as applied mutandis pursuant to Article 50-13, paragraph (3)" and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit"; and in Article 19, the term "Narcotics Exporter" is deemed to be replaced with "Psychotropics Exporter", the term "Narcotic" is deemed to be replaced with "specific type III psychotropic", and the phrase "export permit and certificate of permission for export" is deemed to be replaced with "export permit".

(4)It is permissible for the Minister of Health, Labour and Welfare not to grant the intended permission referred to paragraph (1) or Article 50-12, paragraph (1) or (2) for the export of a specified psychotropic to a destination in a specified region, if the minister does not receive a special import permit prepared by the country of import.

(5)Having granted the permission referred to in paragraph (1) or Article 50-12, paragraph (1) or (2) for the export of a specified psychotropic to a destination in a specified region, in addition to issuing the documents provided for in Article 18, paragraph (4) as applied mutandis pursuant to paragraph (2) or (3) of this Article or pursuant to Article 50-12, paragraphs (3) through (5), the Minister of Health, Labour and Welfare delivers the special import permit prepared by the country of import.

(6)When exporting a specified psychotropic to a destination in a specified region, in addition to sending the documents provided for in Article 18, paragraph (6) as applied mutandis pursuant to paragraph (2) of this Article or to Article 50-12, paragraph (3) or (4), a Psychotropics Exporter or a person set forth in Article 50-11, item (iii) or (iv) must send the special import permit prepared by the country of import along with that psychotropic.

(7)If a person as provided in the preceding paragraph does not export the specified psychotropic within the permitted period referred to in paragraph (1) or Article 50-12, paragraph (1) or (2) for exporting the specified psychotropic to a destination in a specified region, in addition to returning the documents provided in Article 19 as applied mutandis pursuant to paragraph (2) or (3) of this Article or paragraphs (3) through (5) of Article 50-12, it must return the special import permit prepared by the country of import to the Minister of Health, Labour and Welfare within 10 days after the end of that period.

Article 50-14(1)Before exporting a Type II Psychotropic (other than a specified psychotropic for export to a specified region), a Psychotropics Exporter must submit an export notification to the Minister of Health, Labour and Welfare giving the product name of the Type II Psychotropic it seeks to export and the information that Order of the Ministry of Health, Labour and Welfare prescribes (simply referred to as an "export notification" in the following paragraph).

(2)When exporting a Type II Psychotropic (other than a specified psychotropic exported to a destination in a specified region), a Psychotropics Exporter must send an export notification along with the psychotropic.

Article 50-15(1)It is prohibited for a person that is not a Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals to manufacture, formulate a pharmaceutical preparation of, or package a Psychotropic; provided, however, that this does not apply:

(2)It is prohibited for a person that is not a Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals or Psychotropics Processor to turn a Psychotropic into a substance other than a Psychotropic by subjecting it to a chemical transformation; provided, however, that this does not apply if a person engaged in academic research or experimentation and testing at a Facility Conducting Experiments or Research Involving Psychotropics implements that process for the purpose of academic research or experimentation and testing.

Article 50-16(1)It is prohibited for a person that is not a Commercial Psychotropics Handler (except a Psychotropics Processor) to transfer a Psychotropic or to have a Psychotropic in its possession with the objective of transferring it; provided, however, that this does not apply:

(2)It is prohibited for a Psychotropics Importer, a Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals, or a Psychotropics Wholesaler to transfer a Psychotropic to a person other than a Commercial Psychotropics Handler (except a Psychotropics Importer), the operator of a Hospital or Similar Facility, or the Operator of a Facility Conducting Experiments or Research Involving Psychotropics; provided, however, that this does not apply if a Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals or a Psychotropics Wholesaler is returning a Psychotropic accepted from a Psychotropics Importer, nor does it apply in a case provided for by Order of the Ministry of Health, Labour and Welfare.

(3)A Psychotropics Exporter must not transfer Psychotropics except when exporting them; provided, however, that this does not apply if it is returning a Psychotropic it has accepted from a Commercial Psychotropics Handler, nor does it apply in a case provided for by Order of the Ministry of Health, Labour and Welfare.

(4)A Psychotropics Retailer must not transfer a Psychotropic other than to a person in possession of a Psychotropics Prescription; provided, however, that this does not apply if it is returning a Psychotropic accepted from a Commercial Psychotropics Handler, nor does it apply in a case provided for by Order of the Ministry of Health, Labour and Welfare.

Article 50-17When transferring a Psychotropic to a person in possession of a Psychotropics Prescription, a Psychotropics Retailer must not transfer a Psychotropic other than the one dispensed based on that prescription.

Article 50-18Article 19-2 applies mutatis mutandis to a Psychotropics Exporter, and Article 29-2 applies mutatis mutandis to advertisements for Psychotropics. In that case, the term "Narcotic" in Article 19-2 is deemed to be replaced with "Psychotropic".

Article 50-19A Commercial Psychotropics Handler (other than a Psychotropics Retailer) must not transfer a Psychotropic other than one bearing the mark "((向))" (an abbreviation of the word "psychotropic", which is pronounced "kou") and the following information on its container and the packaging directly surrounding that container (hereinafter referred to as the "packaging label" in this Article); provided, however, that this does not apply if the surface area of the container is too small to clearly display the packaging label or in a case provided for by Order of the Ministry of Health, Labour and Welfare, if the handler transfers a Psychotropic bearing a simplified packaging label on its container or the packaging directly surrounding that container pursuant to Order of the Ministry of Health, Labour and Welfare:

Article 50-20(1)A Commercial Psychotropics Handler must engage a person in charge of psychotropics handling for each Commercial Establishment at Which Psychotropics Are Handled; provided, however, that this does not apply to a Commercial Establishment at Which Psychotropics Are Handled where the Commercial Psychotropics Handler personally manages the handling of Psychotropics as the person in charge of psychotropics handling.

(2)A person in charge of psychotropics handling must supervise persons engaged in operations involving the Psychotropics under the management thereof at the relevant Commercial Establishment at Which Psychotropics Are Handled, so as to prevent violations of this Act and violations of dispositions of the Minister of Health, Labour and Welfare or the prefectural governor based on this Act.

(3)A person that is not a pharmacist or a person that Cabinet Order prescribes as having the necessary knowledge and experience to handle Psychotropics may not be appointed as a person in charge of psychotropics handling.

(4)Having engaged a person to be in charge of psychotropics handling or having personally become the person in charge of psychotropics handling, a Commercial Psychotropics Handler must file a notification giving the name of the person in charge of psychotropics handling or indicating that it has personally become the person in charge of psychotropics handling, and giving the information that Order of the Ministry of Health, Labour and Welfare prescribes within 30 days; if the Commercial Psychotropics Handler is a Psychotropics Importer, Psychotropics Exporter, Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals, or Psychotropics Processor, it must file this notification with the Minister of Health, Labour and Welfare; and if the Commercial Psychotropics Handler is a Psychotropics Wholesaler or Psychotropics Retailer, it must file this information with the prefectural governor.

Article 50-21Psychotropics Handlers must act as custodians of the Psychotropics that are under their ownership or dispose of them, or take other necessary measures to prevent Psychotropic abuse, pursuant to Order of the Ministry of Health, Labour and Welfare.

Article 50-22(1)If a Psychotropic under the ownership of a Psychotropics Handler is destroyed or stolen, if it becomes unclear where the Psychotropic is located, or if any other incident occurs involving the Psychotropic, the Psychotropics Handler, pursuant to Order of the Ministry of Health, Labour and Welfare, must promptly file a notification giving the product name and quantity of the Psychotropic and the necessary information to clarify the circumstances of the incident; if the Psychotropics Handler is a Psychotropics Importer, Psychotropics Exporter, Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals, or Psychotropics Processor, or if it is the Operator of a Facility Conducting Experiments or Research Involving Psychotropics that the Minister of Health, Labour and Welfare has registered, it must file this with the Minister of Health, Labour and Welfare; and if the Psychotropics Handler is a Psychotropics Wholesaler, Psychotropics Retailer, or operator of a Hospital or Similar Facility, or if it is the Operator of a Facility Conducting Experiments or Research Involving Psychotropics that the prefectural governor has registered, it must file this with the prefectural governor.

(2)Having received a notification as referred to in the preceding paragraph, a prefectural governor must promptly report this to the Minister of Health, Labour and Welfare.

Article 50-23(1)A Commercial Psychotropics Handler (other than a Psychotropics Retailer) must keep records of the following information:

(2)A Psychotropics Retailer or the operator of a Hospital or Similar Facility must keep records of the following information:

(3)The Operator of a Facility Conducting Experiments or Research Involving Psychotropics must keep records of the following information:

(4)A Psychotropics Handler must keep the records under the preceding three paragraphs on file at its Commercial Establishment at Which Psychotropics Are Handled, Hospital or Similar Facility, or Facility Conducting Experiments or Research Involving Psychotropics for two years after the date that the record is made.

Article 50-24(1)A Psychotropics Importer, Psychotropics Exporter, Psychotropics Manufacturer or Formulator of Psychotropic Pharmaceuticals, or Psychotropics Processor must file a notification with the Minister of Health, Labour and Welfare giving the following information no later than the last day of February of each year:

(2)The Operator of a Facility Conducting Experiments or Research Involving Psychotropics must file a notification no later than the last day of February of each year giving the following information; it must file this with the Minister of Health, Labour and Welfare if it is the Operator of a Facility Conducting Experiments or Research Involving Psychotropics registered thereby; or with the prefectural governor if it is the Operator of a Facility Conducting Experiments or Research Involving Psychotropics registered thereby:

(3)A prefectural governor must compile the notifications referred to in the preceding paragraph and file a report with the Minister of Health, Labour and Welfare no later than April 30 of that year.

Article 50-25It is permissible to employ Cabinet Order to establish a partial exclusion from the application of this Act and prescribe the necessary special measures for a Psychotropic set forth in item (xii) of Appended Table III which poses no risk of abuse and is prescribed by Order of the Ministry of Health, Labour and Welfare as having no harmful effects.

Article 50-26(1)In applying this Act (other than Article 50-4 and Article 50-20, paragraph (4)), a person that has obtained permission (or a renewal of permission) to operate a pharmacy pursuant to the Act on Pharmaceuticals and Medical Devices (hereinafter referred to as the "operator of a pharmacy" in this Article) is deemed to have been licensed as a Psychotropics Wholesaler and Psychotropics Retailer pursuant to Article 50, paragraph (1); and a person that has obtained permission for pharmaceutical wholesales (other than that involving pharmaceuticals provided in Article 83, paragraph (1) of the Act on Pharmaceuticals and Medical Devices; the same applies in this Article) is deemed to have been licensed as a Psychotropics Wholesaler pursuant to Article 50, paragraph (1); provided, however, that this does not apply if the operator of a pharmacy or person that has obtained permission for pharmaceutical wholesales has filed a request to be treated otherwise with the prefectural governor pursuant to Order of the Ministry of Health, Labour and Welfare.

(2)In addition to lapsing pursuant to Article 50-3, the licensing of a person that is deemed to have been licensed as a Psychotropics Wholesaler or Psychotropics Retailer pursuant to the preceding paragraph lapses if:

(3)In a case as referred to in the main clause of paragraph (1), the pharmacy administrator, as prescribed in Article 7, paragraph (3) of the Act on Pharmaceuticals and Medical Devices, that is affiliated with the pharmacy of the relevant operator; or the administrator of the business establishment, as prescribed in Article 35, paragraph (2) of that Act, that is affiliated with the person that has obtained permission for pharmaceutical wholesales, is deemed to be the person in charge of psychotropics handling referred to in Article 50-20, paragraph (1).

(4)The prefectural governor issues a public notice upon having received a request as referred to in the proviso to paragraph (1), or if the licensing of a person that is deemed to have been licensed as a Psychotropics Wholesaler or Psychotropics Retailer pursuant to that paragraph is rescinded pursuant to Article 51, paragraph (2) (but only if the business operations of the pharmacy or pharmaceutical wholesales continue).