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1.

Notifying Member: Japan

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: Ministry of Health, Labour and Welfare

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Pharmaceutical products (HS: 30)

5.

Title, number of pages and language(s) of the notified document: Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 pages, in English)

6.

Description of content: The minimum requirements for radiopharmaceuticals are to be partially amended to add the standards for a radiopharmaceutical to be newly approved.

7.

Objective and rationale, including the nature of urgent problems where applicable: To establish the standard for manufacturing process, properties, quality, storage and others of drugs to which special attention must be paid for the attainment of public health and sanitation (radiopharmaceuticals).

8.

Relevant documents: The act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics. This amendment will be published in "KAMPO" (Official Gazette) when adopted.

9.

Proposed date of adoption: The same day as the approval of the radiopharmaceutical

Proposed date of entry into force: The same day as the approval of the radiopharmaceutical

10.

Final date for comments: 24 September 2015

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

Japan Enquiry Point

International Trade Division

Economic Affairs Bureau

Ministry of Foreign Affairs

Fax: (+81 3) 5501 8343

E-mail: enquiry@mofa.go.jp

https://members.wto.org/crnattachments/2015/TBT/JPN/15_3631_00_e.pdf