G/TBT/N/KOR/1156  
24 July 2023  
(23-5036) 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 (MFDS)  
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 [  ], 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 Regulations on Safety of Pharmaceuticals, etc.; (62 page(s), in 
Korean)  
6. Description of content:  A. Expansion of recognition range of DMF submission (Article 
15 of the draft, No 16 of form)  
Data to be submitted on the manufacturing site of the drug substance for DMF are data 
complying with the drug subst ance GMP. This amendment is to accept data approved by 
the Minister of Food and Drug Safety as manufacturing certificate or the data corresponds 
to the certificate.  
B. Establishment of regulations, such as procedures and methods for approval of the use 
of overseas investigational drugs for therapeutic purposes (Article 28 -2 of the draft)  
As the range of investigational drugs for approval of the use for therapeutic purposes has 
been expanded to include overseas investigational drugs, regulations such as appl ication 
procedures and dossier were prepared.  
C. Enactment of regulations for matters other than minor matters that does not require 
GMP determination of conformance to change (Article 48 -3 of the draft)  G/TBT/N/KOR/1156  
 
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  As the subject of minor changes has been very limite d and the subject of conformance to 
Change has been wide, significant changes that may affect the quality of pharmaceuticals 
were designated as matters other than minor and subject to conformance to change.  
D. Preparation of regulations such as labeling an d standards for medicines and quasi -
drugs for the visually/hearing -impaired (Article 71 -2, 75-2, and 75 -3 of the draft)  
As displaying braille and audio/sign language conversion codes on medicines and quasi -
drugs prescribed by the Minister of Food and Drug Safety for the visually/hearing -
impaired has been mandatory requirements, relevant indication methods and standards 
were established and regulation such as compliance on -site inspection and evaluation 
contents and methods were prepared.  
E. Establishment of  regulations such as methods and procedures for online monitoring of 
illegal medicine sales (Article 71 -3 of the draft)  
As the legal basis for entrusting online monitoring of illegal medicine sales has been 
established, regulations such as monitoring metho ds and procedures were prepared.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  to complement the shortcomings of the current operating system  
8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -333, 12 July 2023  
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 [ ] 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, R epublic of Korea, 
369-811 
Tel.: (+82) 43 870 5525 Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2023/TBT/KOR/23_1 1244_00_x.pdf