G/TBT/N/KOR/963  
26 April 2021  
(21-3509) 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:   
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, 
Chungcheongbuk -do, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
Website: www.mfds.go.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 
Decree of Act on Encouragement of Development and Emergency Distribution of Medical 
Counte rmeasures for Public Health Emergency (25 page(s), in Korean)  
6. Description of content:   
1) Establishment of Establishment of Committee for Safety Management and Circulation 
of Medical Countermeasures (MCs) for Public Health Emergency (PHE) (Article 2 of  the 
draft)  
Central administrative agency for establishment of Committee for Safety Management 
and Circulation of Countermeasures (MCs) for Public Health Emergency(PHE), which was 
designated from the decree, has been designated (10 government departments including 
Ministry of Economy and Finance)  
2) Measure for the medical products granted EUA  (Article 3 of the draft)  
A decision on the measure such as manufacturing, import prohibition, recall abandonment 
and discontinuance of use for the medical products obtained EUA f ollowing consultation 
with Committee for Safety Management and Circulation of MCs for PHE shall be allowed  G/TBT/N/KOR/963  
 
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  3) Details for implementation of tracking (from Article 4 to 6)  
Designation of agencies who are responsible for implementing tracking such as KIDS an d 
NIDS, target, scope, process and method of tracking have been specified  
4) Reporting method and details on adverse event concerning medical products to be 
traced (Article 7 of the draft)  
The adverse event shall be reported to KIDS or NIDS within 15 days of recognizing it 
(within 7 days of recognizing it which leads to death)  
5) Registration of administration details and written consent procedure (Article 8 and 9 
of the  draft)  
Procedures for registration of administration details to be traced (by doctor, d entist, 
pharmacist) and written consent have been specified  
6) Procedure for registration of marketing and distribution details (Article 10 of the draft)  
Procedures for registration of marketing and distribution of medical products to be traced 
have been s pecifie d 
7) Procedure for executive order to manufacture and import (Article 12 of the draft)  
Content, procedure and notification method for executive order to manufacture and 
import of MCs for PHE have been specified  
8) Procedure for intervention for MCs distribution (Article 13 of the draft)  
Content, procedure and notification method for intervention for MCs distribution have 
been specified  
9) Establishment and operation of MCs for PHE information system (Article 15 of the draft)  
MCs for PHE information s ystem infrastructure and operation have been specified  
10) Establishment of standards for calculating fines (Article 14 and 18 of the draft)  
11) Dealing with personally identifiable information (Article 17 of the draft)  
Dealing with personally identifiable  information including identification number has been 
specified  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Establishment of lower norm following promulgation and enforcement of the 
Act; Other  
8. Relevant documents:   
• Ministry of Food and Drug Safety Public Notice No.2021 -146 (7  April 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/963  
 
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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_2966_00_x .pdf