Vietnam: A fine ranging from 20 to 30 million VND for manufacturing drugs in violation of quality regulations at level 3

01:00, 10/07/2024

On September 28, 2020, the Government of Vietnam issued Decree 117/2020/ND-CP stipulating the administrative penalties in the field of healthcare.

Manufacturing of drugs violating quality at level 3, Decree 117/2020/ND-CP

Vietnam: A fine ranging from 20 to 30 million VND for manufacturing drugs in violation of quality regulations at level 3 (Illustrative photo

Under Clause 3, Article 57 of Decree 117/2020/ND-CP, a fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for the commission of one of the following violations in Vietnam:

- Failing to comply with the drug/medicinal ingredient manufacturing or testing process included in the approved application for registration;

- Manufacturing drug in violation of quality regulations at level 3;

- Failing to perform testing for medicinal ingredients and primary packages before they are used in the manufacturing of drugs;

- Failing to have drugs tested by a testing laboratory designated by a competent authority before the sale of drugs which must be tested as prescribed by law;

- Failing to obtain approval when manufacturing drug/medicinal ingredient in case there are major variations compared to the approved application for registration;

- Manufacturing the drug while the marketing authorization has expired unless permitted by law;

- Using medicinal ingredient/herbal ingredient that is not granted marketing authorization, is not included in the announced list of medicinal ingredients, or of which quality standards are not yet announced as prescribed by law.

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

Ty Na

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