Notice - Notification of WTO Members: 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".
WTO code |
G/SPS/N/KOR/636 |
Date notice |
29/04/2019 |
Notice type |
Regular |
Title |
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". |
Summary |
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 designation 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).
|
Product |
Veterinary pharmaceutical products |
Country |
Republic of Korea |
File attach:
NKOR636.pdf
Orther Notice: