G/TBT/N/KOR/812  
 
21 February 2019  
(19-1015) 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 Food and Drug Safety(MFDS) website  (www.mfds.go.kr ). 
Also available from:  
International Cooperation Office  
Ministry of Food and Drug Safety  
187 Osongsaengmyeong2 -ro,  
Osong -eup, Heungdeok -gu, Chengju -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): 
Pharmaceutics (ICS 11.120).  
5. Title, number of pages and language(s) of the notified document: Regulation on 
Safety of Pharmaceuticals, etc. (63 pages, available in Korean) (63 page(s), in Korean)    
6. Description of content: From Article 56 -3 to 56 -7: Develop a concrete procedure 
regarding the registration and inspection of foreign manufacturing site of imported 
pharmaceuticals, etc.  
The following regulation is newly established; where an obligation of registering a foreign 
manufacturing site is imposed on an importer and measures on the safety of 
pharmaceuticals are deemed necessary according to the revision of Pharmaceutical Affairs 
Act, the Minister of Ministry of Food and Drug Safety may ask to suspend the import and 
order the inspection of quality, etc. and request the correcti on with the onsite inspection.  
The purpose of this new regulation is to secure the integrity of the law by regulating 
mandated matters by the Ordinance of the Prime Minister in Pharmaceutical Affairs Act 
including a procedure of registering a foreign manuf acturing site, a subject to register and 
notify of changes, a procedure and method of onsite inspection, measures on suspension 
of import, etc. and any related matter of dissolution, etc.  
7. Objective and rationale, including the nature of urgent problems  where 
applicable: Protection of human health or safety  G/TBT/N/KOR/812  
 
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  8. Relevant documents:  MFDS NOTIFICATION No. 2019 -088 (22 February 2019)   
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 date of 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, 27737  
Republic of Korea  
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/2019/TBT/KOR/19_0998_00_x.pdf