Types of recall and classification of violations of drugs in Vietnam under the Law on Pharmacy 2016

Types of recall and classification of violations of drugs in Vietnam under the Law on Pharmacy 2016 (Internet image) 

Regarding this issue, LawNet would like to answer as follows:

1. Types of recall and classification of violations of drugs in Vietnam under the Law on Pharmacy 2016

Types of recall, classification of violations, scope and time of recall, and disposal of recall drugs according to Article 63 of the Law on Pharmacy 2016 are as follows:

* 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 2 of Article 63 of the Law on Pharmacy 2016 that do not affect the treatment ability and safety of the drug.

* Scope and time of drug recall:

- 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.

* Recall drugs shall be disposed of as follows:

- Drugs recalled in the cases mentioned in Point a and Point b Clause 2 of Article 63 of the Law on Pharmacy 2016 shall be destroyed;

- Drugs recalled in the cases mentioned in Point c Clause 2 of Article 63 of the Law on Pharmacy 2016 may be reprocessed, re-exported, or destroyed if cannot be reprocessed.

2. Responsibility for recalling drugs in Vietnam

Responsibility for recalling drugs in Vietnam according to Article 64 of the Law on Pharmacy 2016 is as follows:

- The applicant, domestic manufacturer, preparing facility, importer or import entrustor whose drug is recalled has the responsibility to:

+ Suspend the manufacture/trade in the drug recalled;

+ Take charge and cooperate with relevant entities in publishing information about the recall drug, organize the recall, and receive recall drug;

+ Dispose of recalled drug;

+ Pay the costs of drug recall and disposal, pay compensation as prescribed by law;

+ Submit a report to the Ministry of Health about the recall and its result;

+ In case of voluntary recall, the trade in such drug must be suspended and a report must be submitted to the Ministry of Health before conducting the recall.

- Drug wholesalers and retailers have the responsibility to:

+ Stop selling and dispensing the drug recalled;

+ Notify and organize the recall, receive drug returned by traders and users;

+ Return the drug to the supplier;

+ Pay the costs of drug recall and disposal and pay compensation if responsible for the recall.

- Health facilities and drug users have responsibility to:

+ Stop prescribing, selling, dispensing and using the drug recalled;

+ Return the drug to the suppliers.

- The Ministry of Health has the responsibilities to:

+ Decide drug recalls and disposal of recall drugs nationwide in consideration of the degree of violations in terms of drug quality, safety, and efficacy;

+ Review reports and respond to proposals of voluntary recalls by manufacturers and traders;

+ Inspect and supervise the recalls; take actions against violators as prescribed by law;

+ Publish information about recalled drugs due to first-degree violations on the website of the Ministry of Health, Vietnam Television, Voice of Vietnam right after the announcement of such recalls.

- Vietnam Television and Voice of Vietnam shall publish information about drug recalls due to first-degree violations free of charge.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE