Severe penalties for manufacturing drugs that are granted marketing authorization in Vietnam

Severe penalties for manufacturing drugs that are granted marketing authorization in Vietnam (Illustrative photo)

Under Decree 117/2020/ND-CP, a fine ranging from VND 60.000.000 to VND 80.000.000 shall be imposed for the commission of one of the following violations in Vietnam:

- Manufacturing and selling drug/medicinal ingredient that is not granted marketing authorization in Vietnam, except drugs/medicinal ingredients that are not required to be registered as prescribed by law;

- Manufacturing drugs using medicinal ingredients which are substandard, subject to a recall notice given by a competent authority, of unknown origin, or have expired;

- Manufacturing drug/medicinal ingredient at a location other than the one specified in the approved application for registration, except the violation in Point b Clause 5 of this Article;

- Manufacturing drug/medicinal ingredient at an establishment that is not issued with the certificate of eligibility for pharmacy business or does not pass the inspection of GMP compliance as prescribed by law;

- Manufacturing drug/medicinal ingredient while business operation or the certificate of eligibility for pharmacy business is suspended;

- Manufacturing products which are not drugs on the production line, except the manufacturing of health supplements on the herbal or traditional drug production line or other cases prescribed by the Minister of Health;

- Manufacturing, processing or preparing a traditional drug containing an active ingredient that is not licensed by a competent authority as prescribed by law.

Additionally, the fine shall be 1.5 times or twice as much as the fine imposed for the above violation but not exceed VND 100.000.000 if the violation involves drugs or active ingredients on the List of banned substances in some fields and sectors, combined drugs that contain narcotic substances, psychotropic ingredients or precursors or radiopharmaceuticals, or involves narcotic drugs, psychotropic drugs, precursor drugs, medicinal ingredients that are narcotic substances or psychotropic ingredients or drug precursors respectively.

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

Ty Na

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