  
  
G/TBT/N/KOR/1121  
6 December 2022  
(22-9077) 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 (MFDS) website 
(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, 28159  
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: intmfds@korea.kr  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
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:  Proposed 
amendments to the Regulation on Safety of Pharmaceuticals, etc.; (43 page(s), in 
Korean)  
6. Description of content:  This amendment clarifies specific dispositions criteria - such as 
the cancellation of GMP compliance determination in case of violation by medicinal product 
manufacturers - which is in relation to the amendments of the "Regulations on Drug 
Safety Notice No. 2022 -436"(notified on September 30, 2022), of which the amendment 
was made to define the dispositions criteria for GMP compliance determi nation 
cancellation in accordance with Article 41 of the Administrative Procedures Act.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Other  
8. Relevant documents:   
MFDS NOTIFICATION No. 2022 -528 (1 December 2022)  G/TBT/N/KOR/1121  
 
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  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:   
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,  
Tel.: (+82) 43 870 5521 Fax: (+82) 43 870 5682  
E-mail: tbt@korea.kr  Website: www.knowtbt.kr  
https://memb ers.wto.org/crnattachments/2022/TBT/KOR/22_8340_00_x.pdf  
 