G/TBT/N/KOR/871  
19 December 2019  
(19-8864) 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, 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 [X], 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:  Regulation on 
Safety of Pharmaceuticals, etc. (95 page(s), in Korean)  
6. Description of content:  Article 4: Reinforcement on product license application 
requirements for pharmaceuticals  
MFDS intends to expand objectives to submit standard, test method data and 
bioequivalence test data into prescription drug, where pharmaceutical manufacturer 
applies for product approval.  
MFDS intends to reinforce the safety management system by requesting them to submit 
the materials, without exception, where a person who intends to apply for approval of 
pharmaceuticals marketing has been already granted appro val for products which are 
same ingredient name and specification with the product for the application, where the 
person asks contract manufacturer to produce the pharmaceuticals under the same 
process as the said manufacturer, it was possible for the appl icant to apply for the 
approval without submission of evaluation materials.  
Article 4, 48: Expansion of targets for Good Manufacturing Practice application  
MFDS intends to improve the regulation by applying pharmaceuticals not directly applied 
to human suc h as disinfectant, which was excluded from it before, to comply with Good 
manufacturing Practice.(provided that the pharmaceuticals such as high pressure medical G/TBT/N/KOR/871  
 
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  gas, which was notified by the prime minister of Ministry of Food and Drug Safety, shall 
be ex cluded).  
Article 48, 48(2): Recommendation of compliance with quasi -drug GMP and issuance of 
certificate of determination of conformance  
MFDS intends to create legal ground to recommend manufacturer to comply with 
manufacturing of quasi -drug and GMP and is sue certificate of determination of 
conformance for the manufacturer which complies with the quasi -drug GMP.  
Article 62(4): Expansion of target for disclosing information on notified pharmaceuticals 
(Article 62 (4))  
MFDS intends to provide more efficient i nformation on the notified pharmaceuticals by 
adding the name of registered pharmaceuticals, which are references of safety and 
efficacy for the information on the website.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:   
• MFDS NOTIFICATION No. 2019 -517 (18 November 2019)  
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:   
Korean Agency for Technology and Standards (KATS)  
93, Isu-ro, Maengdong -myeon, Eumseong -gun, Chungcheongbuk -do, Republic of Korea, 
369-811 
Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682  
E-mail: tbt@korea.kr  Website: http://www.knowtbt.k r 
https://members.wto.org/crnattachments/2019/TBT/KOR/19_7338_00_x.pdf