WORLD TRADE
ORGANIZATIONG/TBT/N/JPN/43
5 April 2002
(02-1800)
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 [     ], 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:   Revision of the
designation of drugs which are not required to be approved for manufacturing and import.
(English, one page)
6. Description of content:   Under the provision of Article 14, paragraph 1 of the
Pharmaceutical Affairs Law, Minister of Health, Labour and Welfare designates drugs,which are not required individual Ministerial approval for manufacturing and import.
Ministry of Health, Labour and Welfare will revise the designation to expand the coverage
of drugs.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Deregulation of the approval of drugs.
8. Relevant documents:   The basic law is the Pharmaceutical Affairs Law.
This partial revision will appear in "KAMPO" (Official Government Gazette)
9. Proposed date of adoption:
Proposed date of entry into force: }June 2002
10. Final date for comments:   31 May 2002
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:           