  
  
G/TBT/N/KOR/1005  
4 November 2021  
(21-8377) 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: wtokfda@korea.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, quasi -drug 
5. Title, number of pages and language(s) of the notified document:  Notification on 
Partial Amendment of 'Regulation for Pharmaceutical Approval, Notification and Reviews' 
(43 page(s), in Korean)  
6. Description of content:  The Ministry of Food and Drug Safety, Republic of Korea intends 
to revise the following ma tters in Regulation for Pharmaceutical Approval, Notification and 
Reviews.  
1.Reinforcement of change control including manufacturing procedure for prescription 
drug 
2. Abolishment of mandatory  regulation on submission of manufacturing and Free Sales 
Certificate for imported new drug.  
3. New Establishment on Example of indications of precaution for use by specifying 
package unit for disposable ophthalmic solutions at less than 0.5ml       
4. Abolishment of foreign national drug formularies -based system to strengthen scientific 
evidence -based safety and validity review system  G/TBT/N/KOR/1005  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Ensuring Pharmaceutical Safety Management; Protection of human health or 
safety; Other  
8. Relevant documents:   
Notification No. 2020 -590 by MFDS (Dec 29, 2020)  
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_7002_00_x.pdf  
 