G/TBT/N/KOR/538
14 November 2014 
(14-6652)  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 of Food and Drug Safety website 
(http://www.mfds.go.kr ). 
Also available from:  
International Cooperation Office Ministry of Food and Drug Safety 
187 Osongsaengmyeong 2-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 Au thorization on Biological Products, etc." (44 
pages, in Korean) 
6. Description of content:  
1. Medical products only for export will be granted to receive a separate product 
approval; 
2. Medical products that are difficult to be manufactured domestically due to their 
unique properties will be granted to allow parts of their manufacturing  process to 
be conducted as overseas commissioned manufacturing; 
3. Provide packaging unit information of a product; 
4. Within the "Certificate for Manufacture and Sales of Imported Biologicals", the 
requirement "active ingredient specifications" may be replaced by the authorization 
application dossier; 
5. When applying for authorization of new an d orphan medical products, it will be 
required to submit a "Risk Management Plan" to minimize adverse events and risk 
factors; G/TBT/N/KOR/538 
 
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  6. Improve the list of required submission  documents (approval dossier) for "whole 
blood products and blood component products" so as to consider the different characteristics of blood products; 
7. In granting authorization for biological products, the manufacturing method for 
bulk and finished products are required  to be stated in the "manufacturing 
method" section, and the manufacturing method for final bulk is required to be 
stated in the "criteria and testing methods" section. The latter requirement will be 
deleted to address this redundancy. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
• To improve and supplement areas that are lacking in current policies; 
• Clarify manufacturing method review criteria and dossier submission requirements 
for whole blood products and blood component products; 
• Require to submit a "Risk Management Plan" to minimize adverse events and risk 
factors. 
8. Relevant documents:  MFDS Notification No. 2014-330 (31 October 2014) 
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 the date of 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 
http://members.wto.org/crnattachments/2014/tbt/KOR/14_5073_00_x.pdf