G/TBT/N/KOR/1185  
14 December 2023  
(23-8574) 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 (MFDS)  
187 Osongsaengmyeong2 -ro, Osong -eup, Heungdoek -gu Cheongju -si, Chungch eongbuk -
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 "ENFORCEMENT DECREE OF THE PHARMACEUTICAL AFFAIRS ACT"; 
(3 page(s), in Korean)  
6. Description of content:  To implement the revision of the Act without difficulties by 
establishing specific criteria for the fine in the case of failure to report the reason for 
expiration of priority marketing authorization, which is responsible by the law, with the 
revision of [Pha rmaceutical Affairs Act] (Act No, 19652, promulgation Date 16 Aug,2023, 
Enforcement Date 17, Feb,2024,), which includes that a person who obtained a priority 
marketing authorization that can market a medicine in priority to the identical medicine 
by receiv ing judgement or decision that means the medicine doesn't fall within the 
invalidity or the scope of patent right shall report it to the Minister of Ministry of Food and 
Drug Safety when a reason arises to the patent to expire.  
7. Objective and rationale,  including the nature of urgent problems where 
applicable:  to complement the shortcomings of the current operating system  G/TBT/N/KOR/1185  
 
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  8. Relevant documents:   
MFDS NOTIFICATION No. 2023 -571, 12 December 2023  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  40 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, Republic of Korea, 
369-811 
Tel.: (+82) 43 870 5315 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_14529_00_x.pdf