Vietnam: Cases of revocation of the Certificate of sale of veterinary drugs

Nguyen Trinh

17:38, 01/01/2017

According to Vietnam’s regulations, in order to be allowed to circulate veterinary drugs, organizations and individuals engaged in the production and import of veterinary drugs must submit a registration dossier for circulation to the Veterinary Department. After being granted the Certificate of Circulation, these organizations and individuals are permitted to carry out this activity. However, during the course of their operations, these organizations and individuals may have their Certificate of Circulation revoked for various reasons.

Specifically, according to Article 83 of the Law on Veterinary Medicine 2015 of Vietnam, the Certificate of sale of veterinary drugs shall be revoked in any of the following cases:

- The Certificate is erased or adjusted in content;

- There is a determination of fake documents or untrue information in the documents of registration for sale that are approved;

- The veterinary drug is banned in Vietnam;

- There is scientific evidence proving that such veterinary drug causes high risks of harmfulness to people’s health, animal’s health and the environment;

- Two constant production batches of the drugs are unconformable to the quality standards or a production batch of the drug seriously violates the quality standards according to the conclusion of State management agencies in charge of quality of veterinary drugs;

- An organization/individual having the Certificate of sale of veterinary drugs in Vietnam applies for revocation of the Certificate;

- The Certificate of sale of veterinary drug granted to such drugs at the manufacturing/exporting country has been revoked;

- Veterinary drug is concluded violating the intellectual property rights by competent agencies;

- An organization/individual having the Certificate of sale of veterinary drugs in Vietnam commits violations against the regulations and incurs the revocation of the Certificate.

The Department of Animal Health is in charge of the revocation of the Certificate of sale of veterinary drugs.

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