THE GOOD CLINICAL PRACTICE OF VETERINARY DRUGS The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.9. 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 Clinical Practice of Veterinary Drugs. 6. Description of content: Establishment of the standards for Good Clinical Practice for Veterinary Drugs. 7. Objective and rationale: To assure the confidentiality for the application data for approval. 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: Not yet determined; Proposed date of entry into force: Not yet determined. 10. Final date for comments: 21 March 1997. 11. Text available from: National enquiry point. (0028)

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