. /.WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/78
8 April 2003
(03-1942)
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
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, quasi-drugs,
cosmetics, medical devices and blood products
5. Title, number of pages and language(s) of the notified document:   Amendment of the
Enforcement Ordinance and enactment of No tifications for Implementing the Revised
Pharmaceutical Affairs Law and the Blood Collection and Donation Arrangement Control
Law.
6. Description of content:   The background and summary of the amendment of the
Enforcement Ordinance and enactment of  notifications for implementing the
Pharmaceutical Affairs Law are as follows:
(1) To amend the Enforcement Ordinance and enact notifications for implementation of
the revised Pharmaceutical Affairs Law (issued in July 2002) in July 2003.
(2) Summary
• To designate individual products which are categorized in "biological
product" or "specified biological product" in accordance with theassessments of potential risks of infectious disease transmission;
• To enact minimum requirements for biological materials used for
production of pharmaceuticals, medical devices and cosmetics in order to
ensure their quality and safety.  (Including criteria for ruminant material
collection regarding countries of origin/source organs/tissues in order to
minimize the risk of BSE transmission);
• To require GMP conformity for manufacturing control and quality
assurance of biological products and specified biological products
equivalent to those of the "biological preparations".G/TBT/N/JPN/78
Page 2
• To require manufacturers of specified biological products to retain the
records of retail (including wholesale) and manufacturing for a period not
less than 30 years etc.
• To require signs identifying biological products or specified biological
products on the direct package/container and to require signs indicating the
country of origin of the human blood as well as how the blood was donated(voluntary donated or otherwise donated) for blood products and specified
biological products including human blood.
• To stipulate the contents of periodic infectious disease reports and the
criteria for supervisors for manufacturing biological products.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To improve measures to ensure safety of biological products, in accordance with advanced
technologies which can be applied to developing new biologicals such as cell/tissue based
products.
8. Relevant documents:   The Pharmaceutical Affairs Law and the  Law to Secure Stable
Supply of Safe Blood Products.  The Enforcement Ordinance and Notifications will appear
in "KAMPO" (Official Government Gazette) when adopted.
9. Proposed date of adoption:
Proposed date of entry into force: }To be determined
10. Final date for comments:   30 April 2003
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: