WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/105
28 November 2003
(03-6326)
Committee on Technical Barriers to Trade Original:  English
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, Labour and Welfare (MHLW)
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [  X ], 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:   Amendment to the
Minimum Requirements for Biological Products (5 pages, available in English)
6. Description of content:   To amend the testing methods for biological products to be
harmonized with the Japanese Pharmacopoeia, the WHO standards, the
U.S. Pharmacopoeia, and others.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To establish the manufacturing process, properties, quality, and storage of biological
products to which special attention must be paid for public health and sanitation.
8. Relevant documents:   The relevant law is the Pharmaceutical Affairs Law.
9. Proposed date of adoption:
Proposed date of entry into force: }March 2004
10. Final date for comments:   30 January 2004
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:           
Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of
Health, Labour and Welfare
Address : 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916 JAPAN
Tel:  +81-3-5253-1111 (ex.2742)
Fax:  +81-3-3597-9535          