Vietnam: A fine of up to 120 million VND imposed on enterprise manufacturing drugs in violation of quality regulations at level 1

Vietnam: A fine of up to 120 million VND imposed on enterprise manufacturing drugs in violation of quality regulations at level 1 (Illustrative photo)

Under Decree 117/2020/ND-CP, a fine ranging from VND 40.000.000 to VND 60.000.000 shall be imposed for the commission of one of the following violations in Vietnam:

- Manufacturing drug in violation of quality regulations at level 1;

- Manufacturing drug/medicinal ingredient at a location other than the registered one by adopting a production line that has been certified by a competent authority to be conformable with GMP;

- Failing to report changes in case of expansion of the existing factory or major repairs or changes in structure or floor plan of the premises or production line;

- Forging or altering any documents, papers or certifications issued by competent authorities and other entities during the manufacturing of drug/medicinal ingredients;

- Manufacturing drug/medicinal ingredient beyond the scope specified in the certificate of eligibility for pharmacy business or scope of inspection of GMP compliance;

- Only maintaining the GMP compliance at level 4.

In addition, according to Clause 4, Article 4 of Decree 117/2020/ND-CP, the fine specified above is applicable to individuals. Therefore, for the same violations, the fine for organizations shall be doubled.

Thus, businesses will be fined from 80,000,000 VND to 120,000,000 VND if they produce medicine violating quality standards at Level 1 according to legal regulations.

More details can be found in Decree 117/2020/ND-CP effective from November 15, 2020.

Ty Na

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