Regulations on registration for sale of veterinary drugs in Vietnam

1. Cases of registration for sale of veterinary drugs

According to Article 80 of the Law on Veterinary Medicine 2015 of Vietnam, any organization/individual producing or importing veterinary drugs shall register with Department of Animal Health for sale in any of the following cases:

- Such veterinary drugs are newly produced in Vietnam;

- Such veterinary drugs are initially imported into Vietnam for trading and producing.

2. Application for the Certificate of sale of veterinary drugs

An application for the Certificate of sale of veterinary drugs shall include:

- An application form;

- Technical documents, sample of the label of drug;

- Reports on results of the analysis of product quality made by manufacturer; results of the testing of quality of veterinary drugs made by a laboratory in Vietnam that is appointed; results of the testing of the effect and safeness of veterinary drugs, applicable to drugs subject to testing;

- The GMP Certificates or the Certificate of eligibility for producing veterinary drugs or the Certificate of eligibility for importing veterinary drugs; the Certificate of sale of veterinary drugs granted by a competent agency of the producing country, applicable to imported drugs.

3. Procedures for the granting of the Certificate of sale of veterinary drugs

Step 1: Submit dossiers

Organizations/individuals shall submit the application to Department of Animal Health;

Step 2: Appraise dossiers and issue the Certificate

- Within 06 months from the day on which the satisfactory application is received, the Department of Animal Health shall examine the documents and grant the Certificate of sale of veterinary drugs;

- If the application is rejected, the Department of Animal Health shall make a written response containing the explanation.

Effective duration of a Certificate of sale of veterinary drugs is 05 years.

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