   
  
G/SPS/N/KOR/636/Add.1  
 
10 May 2019  
(19-3227) Page: 1/2 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 10 May 2019, is being circulated at the request of the 
Delegation of  the Republic of Korea . 
 
_______________  
 
 
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"  
The proposed regulations seek to:  
− Ensure the reliability of "Dossier" to be submitted to get an approval for veterinary pharmaceutical 
products;  
− Describe the detailed regulations on the desi gnation of the clinical trial institution and the non -
clinical trial institution for the veterinary pharmaceutical products;  
− Describe the detailed regulations to get an approval for the veterinary medical devices (writing  
and approval of the clinical trial  protocol, the qualification of the principal investigator).  
https://members.wto.org/crnattachments/2019/SPS/KOR/19_2770_00_x.pdf  
https://members.wto.org/crnattachments/2019/SPS/KOR/19_2770_01_x.pdf  
https://members.wto.or g/crnattachments/2019/SPS/KOR/19_2770_02_x.pdf  
https://members.wto.org/crnattachments/2019/SPS/KOR/19_2770_03_x.pdf  
This addendum concerns a:  
[ ] Modification of final date for comments  
[ ] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[X] Other: This addendum contains the attachments which should appear in Item 5 of 
G/SPS/N/KOR/636.  
Comment period: (If the addendum extends the scope of the previously notified measure 
in terms of products and/or potentially affected Members, a new deadline for receipt of 
comments should be provided, normally of at least 60 calendar days. Under other 
circumstances, such as extension of originally announced final date for comments, the 
comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : 28 June 2019  G/SPS/N/KOR/636/Add.1  
 
- 2 - 
 
  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  
Text(s) available from: [  ] National Notification Authority, [X] National Enquiry Point. 
Address, fax number and e -mail address (if available) of other body:  
  
 
__________  