G/TBT/N/KOR/542
4 December 2014
(14-7066)  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 Heungdeok-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 [ X ], 5.7.1 [   ], other:  
4. Products covered (HS or CCCN where applic able, 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: Proposed 
amendment of the "Regulation on Pharmaceuticals Approval, Notification and Review" (44 
pages, in Korean) 
6. Description of content:  
• Mandate the statement of packaging unit when applying for approval/report of 
pharmaceuticals, and mandate the reporting of its revision; 
• Waive certificate of sales for imported pharmaceuticals(except for new drugs); 
• Waive certificate of manufacture for imported pharmaceuticals (except new drugs) 
manufactured in manufacturing facilities with GMP certification by MFDS; 
• Mandate the submission of data on reference standards when applying for 
approval/report of prescription pharmaceuticals; 
• For injections or products that conducted bioequivalence studies, mandate the 
submission of data on quality and stability when applying for approval/report of 
pharmaceuticals; 
• When applying for approval of new or orphan medical products, mandate the 
submission of a  "Risk Management Plan" which includes safety specifications, 
pharmacovigilance plan, risk minimization plan; G/TBT/N/KOR/542 
 
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  • For pharmaceuticals manufactured using ethanol-containing denaturants, mandate 
manufacturers to state denaturant removal processes and relevant test results conducted according to manufacturing processes; 
• Provide a legal basis for on-site inspections regarding comparative dissolution tests 
that were submitted during approval process. 
7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of human health and safety 
8. Relevant documents:  MFDS Notification No. 2014-351 (19 November 2014) 
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: Nati onal 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 
Republic of Korea, 369-811 
https://members. wto.org/crnattachments/2 014/TBT/KOR/14_5334_00_x.pdf