. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/KOR/130 
11 January 2007 
 (07-0142) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated 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:   Korea Food and Drug Administration 
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):   Quasi-drugs, 
pharmaceuticals 
5. Title, number of pages and language(s) of the notified document:   Proposed 
Amendments of ‘Guidelines for Approval of  Manufacture Import of Drugs Quasi-drugs’
(3 pages, in Korean) 
6. Description of content:   Major proposed revisions are as follows:  
(a) To strengthen the quality standard in the approval of anti-smoking 
supplements in the form of cigarettes by setting maximum allowable level for carcinogenic tar and carbon monoxide in combustion. 
(b) For labels on the package to incl ude the warning statement saying: “a 
potential risk of tar and carbon monoxide in using anti-smoking 
supplements would be similar to in sm oking cigarettes” and test results of 
potentially risky substances, thereb y informing consumers of risk 
information clearly. 
(c) To add 22 hair-dye substances, includi ng 1, 7 – Naphthalenediol for which 
the EU raised bladder cancer risk in case of long term use, to the 
list(attachment 5) of prescriptions with safety and efficacy problem, thereby 
limiting the approval of the 22 substances. 
To permit prescriptions containing acetanilide that  are classified as prescriptions with safety 
efficacy problem, however are widely used as additives of hair dye products in the US, EU 
and Japan as external use only quasi drug. G/TBT/N/KOR/130 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
To improve review process for approval of  Manufacture  Import of Drugs Quasi-drugs’ 
8. Relevant documents:   The Korea Food and Drug Administration Advance Notice No. 
2006-255, December 26, 2006 (Available in Korean) 
9. Proposed date of adoption:   
Proposed date of entry into force:   }To be determined 
10. Final date for comments:   31 January 2007 
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:   
Documents are available from the Korea Food and Drug Administration website 
(www.kfda.go.kr), and are also available from:  
International  Trade and Cooperation Team 
Korea Food and Drug Administration  
#194 Tongilro, Eunpyung-Ku  
Seoul, 122-704 
Republic of Korea  
Telephone: (+82) 2 380 1661 
Telefax: (+82) 2 356 2893  
E-mail: wtokfda@kfda.go.kr