G/SPS/N/KOR /637  
 
29 April 2019  
(19-2908) 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 amendments to "The regulation on the safety 
and efficacy evaluation for veterinary pharmaceutical products" . Language(s):  Korean . 
Number of pages:  12 
6. Description of content:  The proposed amendments mainly focus on the following:  
− Revising the requirements for dossier to be submitted to get an approval for the 
veterinary pharmaceutical products. With regard to the designation of the clinical trial 
institution and the non -clinical trial institution for the veterinary pharmaceutical 
products.  
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 international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international stand ard:  
9. Other relevant documents and language(s) in which these are available:    G/SPS/N/KOR/637  
 
- 2 - 
 
  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 ad dress (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