G/TBT/N/KOR/588  
 
17 June 2015  
(15-3147)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member: REPUBLIC OF KOREA 
If applicable, name of local government involved (Article 3.2 and 7.2):  
2. Agency responsible: Ministry of Food and Drug Safety 
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above : Documents are 
available from the Ministry Food and Drug Safety website ( http://www.mfds.go.kr ) 
Also available from: 
International Cooperation Office Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro,Osong-eup 
Heungdeok-gu, Cheongju-si 
Chungcheongbukdo, 363-700 Republic of Korea 
Tel: (+82) 43719-1564 
Fax: (+82) 43-719-1550 Email: wtokfda@korea.kr  
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 applic able, 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: Proposed 
amendments to the "Regulation on Safety of Pharmaceuticals, etc." (214 pages, in Korean)  
6. Description of content: 
 Specifies documents required to be submitted by importers of medicinal products 
and quasi-drugs for registration pursuant to the Medicinal Product and Quasidrug Importer Reporting System 
 Establishes management standards for importers of medicinal products and 
quasidrugs (including management of fac ilities and their environment, documents 
and their management, etc.) 
 Allows API manufacturing site and API manufacturing procedure to be registered 
separately 
 If quasi-drugs contain preservatives or tar colour, their names should be indicated 
on their packages or containers. 
 Warnings and information on chemical components such as tar and carbon monoxide 
yields per cigarette should be bored on the package of all smoking cessation aids (currently, electronic cigarettes are the only smoking cessation aid that are subject 
to such requirements) 
 Establishes standards for measures against suppliers of finished medicinal products 
when they discontinue production, importation and supply of specific drugs (notified 
by the Minister of Health and Welfare)  and fail to report the reasons of G/TBT/N/KOR/588 
 
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  discontinuation no later than 60 days after the day of suspension 
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety 
8. Relevant documents: MFDS Notification No. 2015-172 (1 June 2015) 
9. Proposed date of adoption: To be determined 
Proposed date of entry into force: To be determined 
10. Final date for comments: 60 days from notification 
11. Texts available from: Nati onal enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:  
Technical Barriers to Trade(TBT) Division 
Korean Agency for Technology and Standards (KATS) 
93, Isu-ro, Maengdong-myeon, Eumseong-gun 
Chungcheongbuk-do Tel.: (+82) 43 870 5525 
Fax: (+82) 43 870 5682 
E-mail: tbt@kats.go.kr   
Website: http://www.knowtbt.kr  
https://members. wto.org/crnattachments/2 015/TBT/KOR/15_2326_00_x.pdf