Cases in which a drug is recalled under the Law on Pharmacy in Vietnam

Cases in which a drug is recalled under the Law on Pharmacy in Vietnam (Internet image)

1. What is drug?

According to Clause 2, Article 2 of the Law on Pharmacy 2016, drug means a preparation that contains active ingredients or herbal ingredients used for prevention, diagnosis, treatment, alleviation of diseases in humans, regulation of human physiological functions, including modern drugs, herbal drugs, traditional drugs, vaccines, and biologicals.

2. Cases in which a drug is recalled in Vietnam

Specifically, in Clause 1, Article 62 of the Law on Pharmacy 2016, a drug shall be recalled in the following cases:

- It is not permitted for free sale as prescribed in Clause 1 Article 59 of the Law on Pharmacy 2016;

- Its certificate of free sale is revoked in any of the cases specified in Point a through e Clause 1 of Article 58 of the Law on Pharmacy 2016;

- The requirements specified in Clause 4 Article 54 or Clause 2 Article 59 of the Law on Pharmacy 2016 are not fully satisfied;

- The drug fails to meet the quality standards or derived from a medicinal ingredient that fails to meet the quality standards;

- A competent authority concludes that the drug is not safe or effective as required;

- There is no evidence that the drug has undergone quality inspection during the manufacture process an before release;

- A foreign pharmacy authority notifies a recall of the drug.

3. Types of drug recall and classification of violations in Vietnam

* Types of recall:

- Voluntary recall means a voluntary recall announced by the applicant, manufacturer, importer, or import entrustor;

- Mandatory recall means a recall under a decision of a competent authority in any of the cases specified in Article 62 of the Law on Pharmacy 2016.

* Classification of violations:

- First-degree violation is a violation where the drug threatens to cause serious harm to the users’ health or life;

- Second-degree violation is a violation where there is evidence that the drug does not guarantee effective treatment or is unsafe for users but does not cause harm to the users’ health or life;

- Third-degree violations are violations other than those specified in Point a and Point b of this Clause that do not affect the treatment ability and safety of the drug.

(Clause 1, 2, Article 63 of the Law on Pharmacy 2016)

4. Scope and time of drug recall in Vietnam

According to Clause 3, Article 63 of the Law on Pharmacy 2016, the scope and time of drug recall are as follows:

- In case of a first-degree violation, the drug shall be recalled from every pharmacy business establishment, health facility, and user within 03 days from the day on which the recall is announced;

- In case of a second-degree violation, the drug shall be recalled from every pharmacy business establishment, health facility, and user within 15 days from the day on which the recall is announced;

- In case of a third-degree violation, the drug shall be recalled from every pharmacy business establishment within 30 days from the day on which the recall is announced;

- In case of a first-degree violation where the recall is beyond the capacity of the domestic manufacturer or importer or import entrustor, or not conducted by the deadline by the domestic manufacturer or importer or import entrustor, the recall shall be enforced as prescribed by law.

A competent authority in charge of organizing the recall, the domestic manufacturer or importer or import entrustor shall pay the costs of recall and dispose of the recalled drug.

Thanh Rin

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