Veterinary drug is a single substance or a mixture of substances including pharmaceuticals, vaccines, biological products, microorganisms, chemicals approved for use in animals for the purpose of disease prevention, treatment, diagnosis, to adjust and restore the growth and reproductive functions of animals. Veterinary drug management plays an important role and also affects public health.
Legal basis:
- Law on Veterinary Medicine 2015
- Circular 13/2016/TT-BNNPTNT on management of veterinary drugs
Procedure and Dossier
Step 1. Apply for import permission for testing
Dossier
- Application form
- ERC/IRC
- Certificate of GMP+, ISO or equivalent certificates
- Certificate of product circulation issued by the country of origin
- Quality analysis sheet of producer
- Product feature summary
Time: 05 working days from the date the valid application is received by the competent state agency
Step 2. Importing and Testing
Step 3. Application for circulation
Dossier:
- Registration form
- Product feature summary
- Sample product label and instruction sheet
- Certificate of GMP+, ISO or equivalent certificates
- Production process
- Quality standards and testing methods
- Research documents on shelf life and stability of drugs
- Quality analysis sheet of the producer’s quality analysis sheet of the testing organization (result of Step 2)
- The commitment not to violate the provisions of the Intellectual Property Law
- Generic drug information
Time: within 06 months from the date the valid application is received by the competent state agency
State fee: 1.350.000 VND per one Certificate
Above is our advice on the issue. If you need more detailed advice as well as how to access this service, please contact Lawyer – Mr. Nguyen Duc Trong directly via hotline: 0912.35.65.75, 0912.35.53.53 or call Free Consultancy Center 1900.6575 or send a service request via email: info@hongbanglawfirm.com
We wish you and your family good health, peace and success!
Best regards!
Hong Bang Law Firm.
