G/TBT/N/KOR/484  
 
1 April 2014  
(14-1986)  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, Ch eongwon-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 [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. 
5. Title, number of pages and language(s) of the notified document:  Pharmaceutical 
Affairs Act (81 pages, available in Korean)     
6. Description of content:   
- Established policies restricting the sale of products marketed later than the 
original drug and approving priority prod ucts as according to the drug patent 
linkage system. 
- Improved the quasi drug labelling system by requiring that quasi drugs defined 
under Pharmaceutical Affairs Act Article 2.7 such as gauze fabric and bandages be properly labelled. Also, in cases where product information is not easily visible, it 
must be printed again on the outer package. 
- Will impose a disciplinary fine of maximum 5% of the total production or import 
income for importers, manufacturers of substandard, spurious products. 
- Established grounds for safety and efficacy  evaluation process of the off-label use 
of drugs and their post-management (submission of records of off-label usage, 
prohibit off-label use when evaluated to be  lacking in safety and efficacy, etc.). G/TBT/N/KOR/484 
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety: 
- To establish policy for preventing the market approval of drug applications that 
present safety and efficacy data of an orig inal drug while the patent of the original 
drug is valid, according to the KOR-US FTA signed in 2007; 
- To provide consumers with accurate information and ensure the safety of 
consumers by improving the quasi drug product information label policy; 
- To ensure public health and effectiveness of the disciplinary fine of maximum 5% 
of total production or import income for importers and manufacturers of 
substandard and spurious products; 
- To provide systematic safety, efficacy evaluation and to strengthen post-
 management of for off-label use of products. 
8. Relevant documents:   MFDS NOTIFICATION No. 2014-63   
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) 96 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  
http://members.wto.org/crnattach ments/2014/tbt/KOR/14_1597_00_x.pdf