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COMMERCE BUSINESS DAILY ISSUE OF APRIL 10,1997 PSA#1821

JAPAN: THE GOOD POST-MARKETING SURVEILLANCE PRACTICE ON VETERINARY DRUGS. The following notification is being circulated in accordance with Article 10.6 G/TBT/Notif.97.91. 1. Member to Agreement notifying: JAPAN. If applicable, name of local government involved (Articles 3.2 and 7.2). 2. Agency responsible: Ministry of Agriculture, Forestry and Fisheries 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): Veterinary Drugs (HS: 30.01, 02, 03, 04). 5. Title, number of pages and language(s) of the notified document: The Good Post-Marketing Surveillance Practice on Veterninary Drugs. 6. Description of content: Establishment of the Standards of Good Post-Marketing Surveillance Practice on Veterinary Drugs. 7. Objective and rationale: To assure the confidentiality for the application data for re-examination and re-evaluation. 8. Relevant documents: The basic law is the Pharmaceutical Affairs Law. This provision will appear in "KAMPO" (Official Government Gazette) when adopted. 9. Proposed date of adoption: 1 April 1997; Proposed date of entry into force: 1 April 1997. 10. Final date for comments: 28 March 1997. 11. Text available from: National enquiry point. (0098)

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