Vietnam: A fine of up to 80 million VND imposed on enterprises trading drugs in violation of quality regulations at level 1

Vietnam: A fine of up to 80 million VND imposed on enterprises trading drugs in violation of quality regulations at level 1 (Illustrative image)

Decree 117/2020/ND-CP stipulates a fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for the commission of one of the following violations in Vietnam:

- Trading drugs in violation of quality regulations at level 1;

- Failing to meet quality standards as prescribed by competent authorities when trading in herbal ingredients that have been preliminarily processed;

- Storing drugs/medicinal ingredients against the conditions written on the labels;

- Changing the location of the existing warehouse or opening a new warehouse at the same business location of the drug/pharmaceutical starting material wholesaler without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law;

- Making changes in the auxiliary system or principles of design or operation of utility systems that may affect storage requirements or conditions without submitting a report on such changes, accompanied by relevant technical documents as prescribed by law.

However, Clause 4, Article 4 of this Decree specifies that the above fine applies to individuals. Therefore, for the above-mentioned violations, the fine for organizations will be doubled.

Thus, enterprises trading drugs in violation of quality regulations at level 1 in Vietnam will be fined from 60,000,000 VND to 80,000,000 VND.

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

Thuy Tram

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE