. /.WORLD TRADE
ORGANIZATIONG/TBT/N/KOR/32
10 April 2002
(02-1931)
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:   REPUBLIC OF KOREA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health 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 [    ], 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):   Pharmaceuticals
5. Title, number of pages and language(s) of the notified document:   Amendment of
"Pharmaceutical law enforcement regu lation" 58 pages, in Korean)
6. Description of content:   When applying for approval of manufacture or importation of a
pharmaceutical product, the following documents should be submitted.
1. Gene combinant medicine, cell culture medicine, biological product, cell treatment
remedy & gene treatment remedy:  documents to prove it compatible with GMP &
biological GMP
2. Raw medicine for listing-up
- documents on facilities for manufacture & quality control;
- document on physio-chemical properties and stability;
- document to prove it compatible with GMP or equal (or over) to GMP;
- document on certificate of analysis on raw medicine.
Re-examination can be exempted when:
3. The number of subject pool for surveillance is too small to satisfy the requirement
for re-examination.G/TBT/N/KOR/32
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7. Objective and rationale, including the na ture of urgent problems where applicable:
Health
8. Relevant documents:   Ministerial Decree of Health and Welfare 208 (2002.1.12)
9. Proposed date of adoption:  12 January 2002
Proposed date of entry into force:
-6.1) 1 January 2003
-6.2) 1 July 2002
-6.3) 12 January 2002
10. Final date for comments:
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:
International Cooperation Division
Office of Planning and ManagementMinistry of Health and Welfare
1 Jungang-Dong
Kwacheon-City
Kyoungi-Do
427-760Republic of Korea
Telephone: +82-2-2110-6152/3
Fax: +82-2-504-6418