Legal documents:
- Law on Veterinary 2015
- Circular No. 13/2016/TT-BNNPTNT on management of veterinary drugs
Order and application for registration of circulation of veterinary drugs
Step 1. Get import license for testing
Required documents:
- The application form
- Enterprise/Investment Registration Certificate
- GMP+, ISO Certificate or equivalent certificates of the manufacturer
- Certificate of free sale, or Marketing Authorization, or Certificate of Pharmaceutical Product issued by the competent stage agency of the origin country
- Certificate of Analysis issued by the manufacturer
- The summary of the product characteristic
Time limit: 05 working days from the date that the dossier is received validly by the competent state agency.
Step 2. Importing and Testing
Step 3. Registration
Required documents:
- The application form
- The summary of the product characteristic
- Sample product label and instruction sheet
- GMP+, ISO Certificate or equivalent certificates of the manufacturer
- Production process
- Quality standards and testing methods
- Research documents on shelf life and stability of drugs
- Certificate of Analysis issued by the manufacturer
- Certificate of Analysis issued by the Vietnamese laboratory (result of Step 2).
- The commitment does not violate the provisions of the Intellectual Property Law
- Generic drug information
Time limit: within 6 months from the date that the dossier is received validly by the competent state agency.
State fee: 1,350,000 VND/certificate
Please contact Intraco Law for detailed advice and quotation.
