Vietnam: Failing to have a GMP Certificate shall be fined from 20 to 25 million VND

Specifically, according to Article 32 of the Decree No. 90/2017/NĐ-CP of Vietnam’s Government, fines for violations against requirements for production, processing and division of veterinary drugs are specified as follows:

1. A fine ranging from VND 4,000,000 to VND 5,000,000 shall be imposed for erasing or altering contents of the GMP Certificate.

2. A fine ranging from VND 5,000,000 to VND 6,000,000 shall be imposed on the person who is in charge of managing the production or analysis of veterinary drugs for failing to possess a veterinary practicing certificate or using an expired veterinary practicing certificate.

3. A fine ranging from VND 6,000,000 to VND 8,000,000 shall be imposed for any of the following violations:

- Have location, workshops, drug warehouses designed with area and distance failing to ensure the safety for human, animals and the environmental protection;

- Use equipment that is not conformable with the scale of production and quality inspection of each type of veterinary drug.

4. A fine ranging from VND 15,000,000 to VND 20,000,000 shall be imposed for each time of production of veterinary drugs at the places other than the one specified in the GMP Certificate or failure to ensure GMP manufacturing conditions licensed by the competent authority.

5. A fine ranging from VND 20,000,000 to VND 25,000,000 shall be imposed for any of the following violations:

- Fail to have a GMP Certificate;

- Use an expired GMP Certificate.

Besides, additional penalties are confiscating GMP Certificate for erasing or altering contents of the GMP Certificate.

View more details at the Decree No. 90/2017/NĐ-CP of Vietnam’s Government, effective from September 15, 2017.

Ty Na

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