G/TBT/N/KOR/960  
6 April 2021  
(21-2819) 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:   
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:  Proposed 
revision of the "Regulation on Safety of Pharmaceuticals, etc." (10 page(s), in Korean)  
6. Description of content:  1) Clarification of submission requirements for registered drug 
substance to receive marketing authorization for finished product (Article 4, Paragraph 
1, subparagraph 7 of the Regulation)  
MFDS intends to clarify the scope of data on  drug substances which have been already 
registered and don't have to be submitted out of those data on drug substances to be 
submitted to apply marketing authorization for finished product.    
2) Preparation of the basis for delegation for new establishment of specific procedures 
to import pharmaceuticals including urgent introduction of pharmaceuticals(Article 57, 
Paragraph 3 of the Regulation)  
For the medicinal products which have supplied through the urgent introduction 
procedure because alte rnative medicinal products are not available, MFDS intends to 
improve efficiency and transparency of operating system by providing a basis for 
delegation for establishment of specific procedure.  
3) Reinforcement of obligation and compliance for wholesalers  to distribute 
pharmaceuticals, etc. (Appendix 6 of the Regulation)  
MFDS intends to improve distribution quality by strengthening obligation and 
compliance for pharmaceuticals wholesalers ,more specifically, while a person who has 
already obtained pharmace uticals marketing authorization, importer and wholesalers G/TBT/N/KOR/960  
 
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  shall maintain proper temperature for the pharmaceuticals during storage and transport 
and shall not install temperature controller on the thermometer, they may add health 
functional food and cosmet ics on the scope of storage list, shall also set specific self 
inspection interval, aside from qualified distributors, all wholesalers shall receive 
training from Korea Pharmaceutical Distribution Association, consignors shall manage 
and supervise consigne es.   
 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To compensate the inadequacies of the current operating system; Other  
8. Relevant documents:   
Ministry of Food and Drug Safety  Public Notice No.2021 -123 (25 March 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/2021/TBT/KOR/21_2458_00_x.pdf