Japan The Principal Law



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Japan

1. The Principal Law

The principal legislation governing the counterfeiting of pharmaceuticals (counterfeit medicines) in Japan are the Pharmaceutical Affairs Law (Enacted by Law No.145 of August 10, 1960 and Lastly Amended by Law No. 103 of December 13, 2013 (Revised Japanese Pharmaceutical Affairs Law will be effective after one year from the promulgation date)(1).

2. Legislation Links

(1) Pharmaceutical Affairs Act

http://law.e-gov.go.jp/cgi-bin/idxselect.cgi?IDX_OPT=1&H_NAME=%96%f2%8e%96%96%40&H_NAME_YOMI=%82%a0&H_NO_GENGO=H&H_NO_YEAR=&H_NO_TYPE=2&H_NO_NO=&H_FILE_NAME=S35HO145&H_RYAKU=1&H_CTG=1&H_YOMI_GUN=1&H_CTG_GUN=1 (Japanese)



3. Extracts of legislation related to the counterfeit medicines:

Pharmaceutical Affairs Law

Article 54(Labelling prohibited being stated)

The following matters shall not be stated on package inserts or on the drug itself, its containers or wrappers of drug (including the inner wrappers):

(1) Entries which are false or which might lead to misunderstanding concerning the drug

(2) Indications or effects for which approval has not be obtained as specified in the provisions of Article 14 or Article 19-2(including cases which apply mutatis mutandis under Article 23; the same hereinafter) or Article 19-2 (excluding indications or effects specified in the standards for drugs designated by the Minister based on specified standards pursuant to the provisions of Article 14, Paragraph 1 or Article 23-2, Paragraph 1)

(3) Directions, doses or periods of use which might jeopardize public health and hygiene.
Article 55 (Prohibition of Sale, Giving, etc.)

1. No one shall sell or store or grant (give) or displays(exhibits) for sale or the giving (grant) drugs which fail to comply with the provisions of the provisions of Articles 50 through 54.

2. No drug which is counterfeited (falsified, faked), which is manufactured or imported in contrary to the provisions of Article 13, Paragraph 1 to 6; Article 14, Paragraph 1 to 9(including cases where it applies mutatis mutandis under Article 19-2, Paragraph 5), Article 19-2, Paragraph 4 or Article 23-2, Paragraph 1 or 4 shall be sold or given(granted), or stored or exhibited (displayed) for the purpose of sale or giving(the grant).

2. No drug which is an imitation of another drug, or is manufactured or imported contrary to the provisions of Article 12, Paragraph 1; Article 18, Paragraph 1 (including cases where it applies mutatis mutandis under Article 23); or Article 22, Paragraph 1, shall be sold or given, or stored or exhibited for the purpose of sale or giving.


Article 56 (Prohibition of Sale, Manufacturing, etc.)

No drug which comes under any of the following items shall be sold or given, or manufactured, imported, stored, or exhibited for the purpose of sale or giving:

(1) A drug which is in the Japanese Pharmacopoeia and for which the quality or properties are not in conformity with the standards established by the Japanese Pharmacopoeia

(2) A drug which is approved according to the provisions of Article 14 or Article 19-2, but whose ingredients or quantities (if active ingredients are not unknown, the essence thereof or outline of manufacturing methods) are different from the details approved)(Excluding the cases which are not in violation of Article 14, Paragraph 10(including cases where it applies mutatis mutandis under Article 19-2, Paragraph 5); (3) A drug designated by the Minister based on specified standards pursuant to the provisions of Article 14, Paragraph 1 or Article 23-2, Paragraph 1 for which the ingredients or quantities(if active ingredients are not unknown, the essence thereof or outline of manufacturing methods), properties or quality do not comply with the standards

(4) A drug for which the standards are laid down under the provisions of Article 42, Paragraph 1 and which is not in conformity with the standards [excluding the standards specified in Article 50, Item (7) and Article 52, Item (3)]

(5) A drug, the whole or a part of which consists of any impure, putrid or decomposed substance

(6) A drug in or on which any foreign matter is found

(7) A drug which is contaminated, or is likely to be contaminated, by pathogenic microorganisms



(8) A drug which bears or contains, for the purpose of coloring only, any coal-tar pigment other than those laid down by MHW ordinance.
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