  
  
G/TBT/N/KOR/1067  
19 April 2022  
(22-3144) 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, 363 -700 
Republic of Korea  
Tel: (+82) 43 719 -1564 
Fax: (+82) 43 -719-1550 
Email: wtokfda@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:  Regulation on 
Safety of Pharm aceuticals, etc.; (28 page(s), in Korean)  
6. Description of content:  To reinforce post marketing safety management and streamline 
submission of use of investigational products for treatment purpose by establishing legal 
basis on order to change of submiss ion deadline of pharmaceutical risk management plan 
and on safety and efficacy review results. And to ensure patients' safety in using the 
investigational products by obligating investigational products providers to manage the 
safety information.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To compensate the inadequacies of the current operating system; Protection 
of human health or safety  
8. Relevant documents:  MFDS Notification No. 2022 -167 (14 April 2021)  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  G/TBT/N/KOR/1067  
 
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  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, R epublic of Korea, 
369-811 
Tel.: (+82) 43 870 5521 Fax: (+82) 43 870 5682  
E-mail: tbt@kats.go.kr  Website: http://www.knowtbt.kr  
https://members.wto.org/crnattachments/2022/TBT/KOR/22_2917_00_x.pdf  
 