G/TBT/N/KOR/581  
 
27 April 2015  
(15-2216)  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 
Heungdoek-gu Cheongju-si 
Chungcheongbuk-do, 363-700 Republic of Korea 
Tel: (+82) 43 719-1564 
Fax: (+82) 43-719-1550 Email: wtokfda@korea.kr  
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Biological products 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the "Regulation of Review and Authorization on Biological Products, etc." 
(8 pages, in Korean)  
6. Description of content:  
 Waive submission of certificate of sales for imported pharmaceuticals(except new 
drugs, cell therapy products, gene therapy products, and orphan drugs of a 
completely new composition of active ingredients different from that of 
already-approved drugs). 
 Waive submission of certificate of manufacture for imported pharmaceuticals 
(except new drugs, cell therapy products, gene therapy products, and orphan 
drugs of a completely new composition of active ingredients different from that of already-approved drugs) manufactured in manufacturing facilities with GMP certification issued by MFDS. 
 Delete the waiver provision of GMP evaluation in approving manufacturing, 
distribution and/or import for orphan drugs: evaluation data of GMP implementation status are to be submitted when applying for the approval of 
manufacturing, distribution and/or import of orphan drugs. G/TBT/N/KOR/581 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of consumer health  
8. Relevant documents:  MFDS Notification No. 2015 (14 April 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 
Republic of Korea, 369-811 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_1730_00_x.pdf