Vietnam: A fine of up to 20 million VND for failing to recall drugs/medicinal ingredients at the request of a competent authority

00:58, 10/07/2024

Recently, the Government of Vietnam issued Decree 117/2020/ND-CP on penalties for administrative violations in medical sector in Vietnam.

Failure to recall drugs, drug materials, Decree 117/2020/ND-CP

Vietnam: A fine of up to 20 million VND for failing to recall drugs/medicinal ingredients at the request of a competent authority (Illustration)

According to Clause 2, Article 58 of Decree 117/2020/ND-CP, 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:

- Trading drugs/medicinal ingredients as samples for registration, testing, scientific research, or display at a fair or exhibition;

- Selling or buying drugs, medicinal ingredients, vaccines or biologicals to or from an establishment beyond its business scope specified in the certificate of eligibility for pharmacy business;

- Trading drugs in violation of quality regulations at level 2;

- Failing to recall drugs/medicinal ingredients at the request of a competent authority.

Concurrently, failure to report the recall results of drugs at the request of a competent authority in Vietnam will also result in a fine ranging from 5,000,000 VND to 10,000,000 VND. Moreover, Clause 1 of Article 58 also specifies 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:

- Trading drugs/medicinal ingredients as samples for registration, testing, scientific research, or display at a fair or exhibition;

- Selling or buying drugs, medicinal ingredients, vaccines or biologicals to or from an establishment beyond its business scope specified in the certificate of eligibility for pharmacy business;

- Trading drugs in violation of quality regulations at level 2;

- Failing to recall drugs/medicinal ingredients at the request of a competent authority.

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

Thuy Tram

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