G/TBT/N/KOR/1006  
4 November 2021  
(21-8380) Page: 1/3 
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 telephone 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 
(www.mfds.go.kr ). 
Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, H eungdoek -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 applicable, 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:  Enforcement 
Rule of Act on Encouragement of Development and Emergency Distribution of Medical 
Countermeasures for Public Health Emergency (59 page(s), in Korean)  
6. Description of content:  1) Establishment of Committee for Safety Management and 
Circulati on of Medical Countermeasures (MCs) for Public Health Emergency (PHE) (Article 
3 of the Draft)  
Tenure of the commissioner (2 year) of the committee and the ground such as mental 
and physical disability to dismiss the committee, which was delegated from the  decree, 
has been prepared  
2) Expulsion/avoidance/evasion of committee commissioner (Article 4 of the draft)  
If it is not available for a commissioner to fairly deliberate and vote, it is possible to expel, 
avoid and evade the commissioner  
3) Operation of committee (Article 5 of the draft)  
Detailed guidance concerning operation such as role of the chair, convoca tion of the 
committee, reproposal, decision criteria and consultation has been established  G/TBT/N/KOR/1006  
 
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  4) Composition of subcommittee (Article 6 of the draft)  
For more professional deliberation, subcommittee for safety management and circulation 
have been established  
5) Designation of preliminary MCs for PHE (Article 9 of the draft)  
Designation of preliminary MCs for PHE form, application method, issuance of designation 
and designation notification method, etc. have been specified  
6) Procedure and method of priority review, rolling review (Article 10 and 11 of the draft)  
Review on preliminary MCs for PHE shall be conducted within 40 days and document 
submission and authorization form for rolling review has been specified  
7) Application for conditional marketing autho rization (Article 13 of the draft)  
For application for conditional marketing authorization of preliminary MCs for PHE, data 
to be submitted for each medical product shall be clearly defined  
8) Procedure and method of Emergency Use Authorization (EUA) (Art icle 14 of the draft)  
Required procedure, date to be submitted by manufacturer and processing procedure for 
EUA shall be specified  
9) Procedure and method of safety use (Article 15 of the draft)  
Procedure on Type and reporting of safety use and report ana lysis of medical products 
obtained conditional marketing authorization shall be prepared  
10) Reporting adverse event (Article 16 of the draft)  
Procedure on reporting on adverse event for medical products granted conditional 
marketing authorization to Kore a Institute of Drug Safety & Risk Management (KIDS) and 
National Institute of Medical Device Safety Information (NIDS) shall be prepared  
11) Establishment of traceability and tracking system (Article 17 of the draft)  
Item and timeline required for traceabi lity and tracking system shall be specified  
12) Designation process and method of MCs for PHE (Article 19 of the draft)  
Designation process, method, issuance of designation form and publication on the website 
of MCs for PHE shall be specified.  
13) Scope ‧ method and process for investigation (Article 20 of the draft)  
Investigation scope of medical products, notice for investigation target and qualification 
for investigator  
14) Establishment of standards of administrative disposition (Article 21 of the draft)  
Standards of administrative disposition for violation of this Act shall be established  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Establishment of lower norm following promulgation and enforcement of the 
Act; Protection of human health or safety; Other  
8. Relevant documents:   
Notification No. 2021 -147 by MFDS (Apr 7, 2021)  
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  G/TBT/N/KOR/1006  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standards (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do  
27737  
+(82) 43 870 5525  
+(82) 43 870 5682 (Fax)  
tbt@korea.kr  
http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2021/TBT/KOR/21_7003_00_x .pdf