WORLD TRADE
ORGANIZATIONG/TBT/Notif.99.359
30 July 1999
(99-3230)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
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 shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [     ], 2.10.1 [    ], 5.6.2 [ X], 5.7.1 [    ], other:           
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:   Partial Revision of
the Minimum Requirements for Biological Substances and Blood Products of Japan
(available in English, 1 page)
6. Description of content:   Under the provision of Article 42, paragraph 1 of the
Pharmaceutical Affairs Law, Minister of Health and Welfare revises some parts of the
minimum requirements for Biological  Substances and Blood Products.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Requirement of testing for hepatitis C RNA by Nucleic acid Amplification Technology
(NAT) methods for blood products under the section of Monographs.
8. Relevant documents:
The basic law is the Pharmaceutical Affairs Law
This partial revision will appear in "KAMPO" (Official Gazette)
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   20 September 1999
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:           