G/TBT/N/KOR/493  
 
19 May 2014  
(14-3028)  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 telephon e 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 website 
(http://www.mfds.go.kr ). Also available from: 
International Cooperation Office 
Ministry of Food and Drug Safety 187 Osongsaengmyeong2-ro, Osong-eup, Cheongwon-gun, 
Chungcheongbuk-do, 363-700 
Republic of Korea Tel: (+82) 43719-1564 
Fax: (+82) 43-719-1550 
Email: wtokfda@korea.kr  
3. Notified under Article 2.9.2 [   ], 2.10.1 [   ], 5.6.2 [ X ], 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 
5. Title, number of pages and langua ge(s) of the notified document: Revised Decree 
of the "Regulation on Safety of Pharmaceuticals" (29 pages, in Korean) 
6. Description of content: 
 Newly establish that pharmaceutical manufacturing sites must be in conformity 
with manufacturing and quality control standards. They will be issued with a certificate (from the Minister of MFDS or, Commissioners of Regional KFDA) that 
confirms the above, which is valid for 3 years. When manufacturing sites with a 
valid certificate apply for drug approval, the certificate may replace evaluation data on pharmaceutical manufacturing and quality control. 
 Revise that when drugs under National Batch Release are used as drug substance 
to manufacture pharmaceutical products, the quality evaluation process may be streamlined. If examination result reports from the manufacturer, and a document which certifies that the drug is under National Batch Release are submitted, only 
verification tests and visual inspection may be conducted. 
 Newly establish regulations that provide the basis for an administrative measure 
when those with drug approval and importers do not comply with Good Supply 
Practice. G/TBT/N/KOR/493 
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of human health or safety  
 To mitigate burden on companies by en suring the distribution and manufacture 
of safe pharmaceutical products through strengthened quality control and 
streamlining of approval process. 
 To mitigate burden on companies by st reamlining the quality evaluation process 
when drugs under National Batch Release are used as drug substance. 
 To secure the safety and quality of pharmaceutical products by imposing 
administrative measures when requirements of Good Supply Practice are not 
met. 
8. Relevant documents:  MFDS NOTIFICATION No. 2014-114 (7 May 2014) 
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined To be determined 
10. Final date for comments: 60 days from date of notification 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:  
Technical Barriers to Trade (TBT) Division 
Korean Agency for Technology and Standards (KATS) 
98 Gyoyukwongil, Gwacheon-si, Gyeonggi-do, Rep. of Korea 427-716 
Tel.:  (+82) 2 509 7254/7255 Fax:  (+82) 2 509 7307 E-mail:  tbt@kats.go.kr  
Website:  http://www.knowtbt.kr  
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