(vasep.com.vn) In February 13th 2012, Ministry of Agriculture and Rural Development (MARD) promulgated the circular No. 08 /2012/TT-BNNPTNN regulating registration procedures of outsourcing veterinary drugs (including drugs used in aquaculture). The circular is subject to domestic and international organizations involving in outsourcing veterinary medicine in Vietnam.
Pursuant to the circular, the provisions of registration for veterinary medicine outsourcing comprise of:
1. To have a permission for outsourcing, the veterinary medicine products must be granted circulation license in Vietnam within period of validity or the veterinary medicine products without circulation certificate are only outsourced for export.
2. Veterinary drug producing plants must have Good Manufacturing Practice (GMP) granted by Department of Animal Health certify. Their products must be appropriate to veterinary drug products registered to outsource.
3. Veterinary drug outsourcing must include all steps in the manufacturing process. Veterinary drug producing plants which want to have production license must pay fee, cost for confirmation of their files, cost for certificate issuance under current law.
The circular comes into force after 45 days of signing.
KT