Vietnam: Severe penalties for failure to retain documents on manufacturing of drugs/pharmaceutical starting materials

01:00, 10/07/2024

This is the main content stipulated in Decree 117/2020/ND-CP issued on September 28, 2020 by the Government of Vietnam on penalties for administrative violations in medical sector in Vietnam.

Failure to retain drug production records, drug raw materials - Decree 117/2020/ND-CP

Vietnam: Severe penalties for failure to retain documents on manufacturing of drugs/medicinal ingredients (illustrative photo)

Decree 117/2020/ND-CP will replace Decree 176/2013/ND-CP prescribing a fine for failing to retain or inadequately retaining documents on manufacturing of drug/medicinal ingredient as prescribed by Vietnamese law. Specifically, under Decree 117, a fine ranging from VND 10.000.000 to VND 20.000.000 shall be imposed for the commission of one of the following violations in Vietnam:

- Failing to send a notification to competent authorities when manufacturing drug/medicinal ingredient in case there are minor variations compared to the approved application for registration which requires notification;

- Failing to obtain an approval from a competent authority when manufacturing drug/medicinal ingredient in case there are minor variations compared to the approved application for registration which requires an approval from a competent authority;

- Failing to retain samples of drug/medicinal ingredient when performing drug/medicinal ingredient testing as prescribed by law;

- Failing to retain or inadequately retaining documents about the manufacturing of drug/medicinal ingredient 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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