JAPAN: THE ENFORCEMENT ORDINANCE OF THE DESIGNATION ON VETERINARY DRUGS WHICH ARE PRESCRIBED IN THE PHARMACEUTICAL AFFAIRS LAW ARTICLE 13-2 The following notification is being circulated in accordance with Article 10.6. G/TBT/Notif.97.357. 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 5.7.1 4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Foot-and-mouth disease inactivated vaccine limited to include the O type of foot-and-mouth disease inactivated virus (HS:30.02). 5. Title, number of pages and language(s) of the notified document: The Enforcement Ordinance of the Designation on Veterinary Drugs which are Prescribed in the Pharmaceutical Affairs Law Article 13-2 (6 pages, available in Japanese). 6. Description of content: The Minister of Agriculture, Forestry and Fisheries designates foot-and-mouth disease inactivated vaccine limited to include the O type of foot-and-mouth disease inactivated virus as the veterinary drug that the Minister licenses traders to import before usual approval procedures are conducted. The Minister also designates the countries from where they can import these drugs under this procedure as follows: Germany, Netherlands and United Kingdom. 7. Objective and rationale: In the light of the outbreak of the foot-and-mouth disease in Chinese Taipei, it has become imperative to make it possible to import foot-and-mouth disease inactivated vaccine in case of the outbreak of the disease in Japan. Therefore, the Minister of Agriculture, Forestry and Fisheries designates the inactivated vaccine as the veterinary drugs that traders can import before usual approval procedures are applied. The Minister also designates the countries as exporting countries of the vaccine where they have the steadfast administrative system for approval of drugs the same as thatof Japan. 8. Relevant documents: The basic law is the Pharmaceutical Affairs Law. This Standard will be made public 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: Not listed. 11. Text available from: National enquiry point. (0205)

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