G/TBT/N/KOR/462  
 
13 January 2014  
(14-0098)  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 :    
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:  Regulations on 
Safety of Pharmaceuticals, etc. (32 pages, in Korean).     
6. Description of content:   
 Any person who intends to apply for an approval or to report a notification in 
manufacturing, marketing or import items for animal origin materials and medical products containing those materials (limited to injections) shall submit 
specifications and test methods data including virus inactivation. 
 Any person who intends to apply for an approval in manufacturing and marketing 
or import items for innovative drugs or orphan drugs, he or she should submit a 
comprehensive Medicine Safety Management Plan including Risk Mitigation 
Measures such as patient¡¯s package insert and measures that ensure the safe use. 
 The current scope of quasi-drugs that are subject to GMP is extended to 
cataplasma(s) and ointments from oral solids and oral liquids. 
 It will be allowed that a part of summar ized information on directions and dose, 
warnings for use and handling and effectiveness and effect can be described for 
non-prescription medicines. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
Protection of consumers and promotion of public health  To ensure the safety of animal origin medicines (limited to injections) and enhance 
product quality management.  
 To proactively address the side effects by taking pre-emptive measures including 
appropriate dose designed to mitigate the risk of taking innovative drugs and orphan drugs and to promote their safe use.  
 To reinforce quality management on quasi drugs which used to be treated as G/TBT/N/KOR/462 
 
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  medical products such as cataplasma(s) and ointments by extending the scope of 
GMP applied to quasi drugs. 
 To facilitate easy understanding of important information on directions and dose, 
warnings for use and handling and efficacy and effect of medical products from 
consumers' point of view. 
8. Relevant documents:   MFDS NOTIFICATION No. 2013-273   
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 the date of notification  
11. Text available from:  National enquiry point [  ], 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/crnattachments/2014/TBT/KOR/14_0030_00_x.pdf