G/SPS/N/KOR/636  
 
29 April 2019  
(19-2907) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member:  REPUBLIC OF KOREA  
If applicable, name of local government involved:   
2. Agency responsible:  Animal and Plant Quarantine Agency (APQA), Ministry of 
Agriculture, Food and Rural Affairs (MAFRA)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Veterinary pharmaceutical products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Proposed regulations: "The designation regulation of 
the clinical trial institution for veterinary pharmaceutical products" ; "The designation 
regulation of non -clinical trial institution for veterinary pharmaceutical products" ; "The 
designation regulation of the clinical trial institution for veterinary medical devices" ; "The 
guidelines of the clinical trial for veterinary medical devices" . Language(s):  Korean . 
Number of pages:  32, 68, 34 and 11 
6. Description of content:  The proposed regulation s seek to:  
− Ensure the reliability of "Dossier" to be submitted to get an approval f or veterinary 
pharmaceutical products ; 
− Describe the detailed regulations on the designation of the clinical trial institution and 
the non -clinical trial institution for the veterinary pharmaceutical products ;  
− Describe the detailed regulations to get an ap proval for the veterinary medical devices 
(writing and approval of the clinical trial protocol, the qualification of the principal 
investigator) . 
7. Objective and rationale: [  ] food safety, [X]  animal health, [  ] plant protection, 
[ ] protect humans from  animal/plant pest or disease, [  ] protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant inte rnational standard?  G/SPS/N/KOR/636  
 
- 2 - 
 
  [ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:    
10. Proposed date of adoption (dd/mm/yy) : To be determined . 
Proposed date of publication (dd/mm/yy) : To be determined . 
11. Proposed date of entry into force: [  ] Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined . 
[ ] Trade facilitating measure   
12. Final date for comments : [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 28 June 2019  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:   
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  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (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