G/TBT/N/KOR/1051  
10 January 2022  
(22-0242) 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 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, 28159  
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; PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  The Amendment 
to the "Regulation on Designation, and Approval Procedure and Method of Pharmaceutical 
Products for National Lot Release" (25 page(s), in Korean)  
6. Description of content:  The Amendment to the Regulatio n on Designation, and 
Approval Procedure and Method of Pharmaceutical Products for National Lot Release:  
1. Clarifies details, including quantity of samples, period for the procedure, etc., of 
SARS -CoV-2 viral vector vaccines and other newly authorized pharmaceutical 
products subject to national lot release;  
2. Clarifies products subject to be classified as carryi ng risk level 3 (subject to 
summary protocol review and test on entire items) as products (A) which have 
received national lot release inappropriately, (B) of which master formula is not 
provided during on -site inspection, or (C) for which false test resul ts were 
submitted; and  
3. Modifies quantity for samples of items including anti -tetanus immunoglobulin.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety; Quality requirements  G/TBT/N/KOR/1051  
 
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  8. Relevant documents:  Notification No. 2021 -616 by MFDS (December 27, 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  
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/2022/TBT/KOR/22_0275_00_x.pdf