Vietnam: A fine of up to 30 million for failing to update standards on the quality of drugs/medicinal ingredients

Vietnam: A fine of up to 30 million for failing to update standards on the quality of drugs/medicinal ingredients (Illustrative image)

According to Article 56 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 retain documents related to the drug/medicinal ingredient registration or failing to provide information on the registered drug when there is information or evidence about the safety and efficacy of the drug during the effective period of its marketing authorization to competent authorities at their request;

- Failing to publish information about the recalled drug or failing to organize the recall and receive the recalled drug as prescribed by law;

- Failing to update standards on the quality of drugs/medicinal ingredients as prescribed by law.

In addition, 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 report or provide information on the registration of drugs in Vietnam according to regulations on obligations of applicants for drug registration and of drug manufacturers or at the request of competent authorities, unless a written representation is provided and accepted by competent authorities;

- Failing to follow procedures for adjustment of certificate of registration before the sale of drugs/medicinal ingredients in case of minor variations only requiring notification;

- Failing to notify competent authorities of suspension of manufacture or supply of drugs or of the scarcity or threat of scarcity of drugs or medicinal ingredients.

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

Ty Na

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