Korea | Proposed amendments to "The regulation on the safety and efficacy evaluation for veterinary pharmaceutical products"

Title of document
Proposed amendments to "The regulation on the safety and efficacy evaluation for veterinary pharmaceutical products" (12 page(s), in Korean)

Description
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, etc.

Notifying member: Korea, Republic of

Notification: G/TBT/N/KOR/822

Objective tag
Protection of animal or plant life or health

Objective
Revising "The requirements for dossier"

Documents

• 19_2130_00_x.pdf

Agency responsible
Veterinary Pharmaceutical Management Division Animal and Plant Quarantine Agency 177, Hyeoksin 8-ro, Gimcheon-si, Gyeongsangbuk-do, 39660 Republic of Korea Tel: (+82)549120532 Fax: (+82)549120530 E-mail: lsm772@korea.kr Website : http://www.qia.go.kr

Timing:

• Submission: 11/04/2019
• Reception: 11/04/2019
• Distribution: 11/04/2019
• Final date for comments: 10/06/2019
• Proposed date of adoption: N/A