KOR/821
WTO/TBT
KR Südkorea
  • 11 - Medizintechnik
2019-06-10
2019-04-12

Veterinary pharmaceutical products

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, available in Korean)

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 medical devices (writing & approval of the clinical trial protocol, the qualification of the principal investigator etc.)