G/TBT/N/KOR/520  
 
27 August 2014  
(14-4915)  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 [ 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): Human tissue 
5. Title, number of pages and language(s) of the notified document: Proposed 
amendments to the "Regulations on Safety  of Human Tissue" (95 pages, in Korean) 
6. Description of content: 
 Human tissues that have violated donation agreements and those from non-licensed 
tissue banks have been included in the list of tissue prohibited from distribution and 
transplantation; 
 Tissue banks are required to verify medica l and medicine administration history of 
tissue donors from the Health Insurance Review and Assessment Service. Should 
tissues banned from distribution and transplantation be found, they must be 
disposed of and reported to the Mi nistry of Food and Drug Safety; 
 Specify requirements when applying for approval for change of tissue banks: Change 
of name, representative, location and head of a tissue bank, types of tissues 
handled, processing procedure of tissues etc,; 
 Clarify the work scope of medical managers at tissue banks; 
 Clarify the documents required for renewal of approval at tissues banks: Original 
copy of tissue bank establishment license,  status of facilities, equipment, human 
resources, Standard Operating Procedur e (SOP), tissue handling records, etc.; 
 Good Tissue Practice (GTP) have been defined in the compliance requirements of 
head of tissue banks; G/TBT/N/KOR/520 
 
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   Define container and package sealing methods, and labeling methods (information 
on container package labels and enclosed documents need to be displayed separately); 
 For more efficient control of imported human tissues, a human tissue import 
approval system (change approval includ ed) has been implemented, along with 
details and methods regarding overseas tissue banks audits; 
 Mandate tissue banks to establish and operate tracking systems for all handled 
tissues, and extend the reporting scope of side effects (side effects that are not "serious" will also need to be reported); 
 Newly established administrative procedures, methods, and other related regulations 
regarding recall and disposal orders of human tissues. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of consumers and promotion of public health  
8. Relevant documents:  MFDS Notification No. 2014-237 (20 August 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_3862_00_x.pdf