G/TBT/N/KOR/821  
 
11 April 2019  
(19-2395) 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:   
Veterinary Pharmaceutical Management Division  
Animal and Plant Quarantine Agency  
177, Hyeoksin 8 -ro, Gimcheon -si, Gyeongsangbuk -do, 39660 Republic of Korea  
Tel: (+82)549120532  
Fax: (+82)549120530  
E-mail: lsm772@korea.kr   
Website: http://www.qia.go.kr  
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:   
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 applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Veterinary 
pharmaceutical products  
5. Title, number of pages and language(s) of the notified document:  Proposed " The 
designation regulation of the clinical trial institution for veterinary pharmaceutical 
products" (32 pages, available in Korean) - Proposed "The designation regulation of non -
clinical trial institution for veterinary pharmaceutical products" (68 pages,  available in 
Korean) - Proposed "The designation regulation of the clinical trial institution for 
veterinary medical devices" (35 pages, available in Korean) - Proposed "The guidelines of 
the clinical trial for veterinary medical devices" (11 pages, avail able in Korean)  
6. Description of content:   
- Ensure the reliability of "Dossier" to be submitted to get an approval for veterinary 
pharmaceutical products, etc.  
- Describe the detailed regulations on the designation of the clinical trial institution 
and the non -clinical trial institution for the veterinary pharmaceutical products, etc.  
- Describe the detailed regulations to get an approval for the veterinary medica l 
devices (writing &amp; approval of the clinical trial protocol, the qualification of the 
principal investigator etc.)  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Ensure the reliability of "Dossier" to be submitt ed to get an approval for 
veterinary pharmaceutical products, etc.;  G/TBT/N/KOR/821  
 
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  8. Relevant documents:   
- 
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 notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
Documents are available from the Animal and Plant Quarantine Agency website at 
http://www.qia.go.kr  
Also available from:   
Ministry of Agriculture, Food and Rural Affairs /MAFRA  
94 Dasom2 -ro, Government Complex -Sejong, Sejong -si 339 -012, Republic of Korea  
Tel:  +(82 44) 201 -2080/2081  
Fax: +(82 44) 868 -0449 
E-mail: wtoagri@korea.kr   
https://members.wto.org/crnattachments/2019/TBT/KOR/19_2129_00_x.pdf  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_2129_01_x.pdf  
https://members.wto.org/crnattachments/2019/TBT/KOR/19_2129_02_ x.pdf 
https://members.wto.org/crnattachments/2019/TBT/KOR/19_2129_03_x.pdf