G/TBT/N/KOR/539
4 December 2014 
(14-7063)  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 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): Human tissues 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the "Detailed implementation regulations on tissue bank approval and safety 
management of human tissue" (79 pages, in Korean) 
6. Description of content:  
1. Provide a detailed range and requirements of necessary documents for the 
establishment approval of "Tissue Bank"; 
2. Introduce details regarding approval for change of "Tissue Bank"; 
3. Expand the scope of consultation provided by the "Tissue Bank Evaluation 
Committee"; 
4. Provide a detailed range and requirements  of necessary documents for the renewal 
of a Tissue bank's approval; 
5. Establish a detailed legal basis on approval for import and approval for change for 
tissues; 
6. Establish detailed procedures for the retrieval and disposal of tissues; 
7. Establish a detailed requirement for the framework in tracking, monitoring tissues 
and recording its distribution history, as well as the reporting format and methods 
for adverse events. G/TBT/N/KOR/539 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
With the revision of "Safety, Management , etc., of Human Tissue Act" to specify 
regulations relating to the import approval of tissues and tracking monitoring record 
mechanism. To improve and complement areas that were lacking in the current system.  
8. Relevant documents:  MFDS Notification No. 2014-350 (19 November 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 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 
https://members. wto.org/crnattachments/2 014/TBT/KOR/14_5328_00_x.pdf