JAPAN: REVISION OF THE DESIGNATION OF DRUGS WHICH ARE NOT REQUIRED TO BE APPROVED FOR MANUFACTURING AND IMPORT The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.117. 1. Member to Agreement notifying: JAPAN. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Ministry of Health and Welfare. Agency or authority designated to handle comments regarding the notification can be indicated if different from above. 3. Notified under Article 5.6.2. 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Drugs (HS: 30). 5. Title, number of pages and language(s) of the notified document: Revision of the Designation of Drugs which are not Required to be Approved for Manufacturing and Import (1 page, English). 6. Description of content: Under the provision of Article 14, paragraph 1 of the Pharmaceutical Affairs Law, the Minister of Health and Welfare designates drugs, which do not require individual Ministerial approval for manufacturing and import.The Ministry of Health and Welfare will revise the designation to expand the coverage of drugs. 7. Objective and rationale: Deregulation of the approval on drugs. 8. Relevant documents: The basic law is the Pharmaceutical Affairs Law. This revision will appear in "KAMPO" (Official Government Gazette) when adopted. 9. Proposed date of adoption: 1 May 1997 ; Proposed date of entry into force: 1 May 1997. 10. Final date for comments: 16 June 1997. 11. Text available from: National enquiry point. (0112)

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