G/TBT/N/KOR/1089  
4 August 2022  
(22-5817) 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  OfficeMinistry  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-
1564Fax:  (+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:  Enforcement 
Decree Of The Pha rmaceutical Affairs Act; (11 page(s), in Korean)  
6. Description of content:  As the Pharmaceutical Affairs Act was revised adding the phrase 
'The Minister of the Ministry of Food and Drug Safety may announce the description of 
the violation which was confi rmed with the administrative measure due to the violation 
of the Act' (Act No. 18970, Notification Date June 10, 2022, Enforcement Date December 
11, 2022), to establish a legal basis of determination of conformity on GMP and access 
and inspection for the m anufacturer by the GMP inspector.  
In addition, to prescribe what is mandated by the Act including content of the documents 
and content method of the public Announcement of the respecting the description of 
violation and what is necessary to implement the m andates in the Act, if a GMP inspector 
intends to access the manufacturer and carry out the inspection on the facility.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  To compensate the inadequacies of the current operating system  
8. Relevant documents:  MFDS Notification No.2022 -341 (29 July 2022)  
9. Proposed date of adoption:  - 
Proposed date of entry into force:  To be determined  G/TBT/N/KOR/1089  
 
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  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:   
Korea WTO TBT Enquiry Point  
Technical Barriers to Trade (TBT) Division  
Korean Agency for Technology and Standar ds (KATS)  
93 Isu -ro Maengdong -myeon Eumseong -gun 
Chungchungbuk -do 
Tel: +(82) 43 870 5521  
Fax: +(82) 43 870 5682  
Email: tbt@korea.kr  
Website: http://www.knowtbt.kr  
https://www.mfds.go.kr/brd/m_209/view.do?seq=43673&srchFr=&srchTo=&srchWor d=
&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm
=&page=1  
https://members.wto.org/crnattachments/2022/TBT/KOR/22_5138_00_x.pdf