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COMMERCE BUSINESS DAILY ISSUE OF APRIL 10,1997 PSA#1821JAPAN: 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) Loren Data Corp. http://www.ld.com (SYN# 0490 19970410\FO-0017)
FO - Foreign Government Standards Index Page
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