Cases in which a drug or medicinal ingredient is recalled in Vietnam

Cases in which a drug or medicinal ingredient is recalled in Vietnam

(1) 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.

(2) A medicinal ingredient being sold on the market shall be recalled in the following cases:

- It is used for improper purposes;

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

- The requirements specified in Clause 4 Article 54 or Clause 3 Article 59 of the Law on Pharmacy 2016 are not fully satisfied;

- The medicinal ingredient is not qualified for drug manufacture; the medicinal ingredient is not conformable with the import license or its origin is different from that written on the certificate of free sale;

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

- A foreign pharmacy authority notifies a recall of the medicinal ingredient.

Pursuant to: Article 62 of the Law on Pharmacy 2016

Cases in which a drug or medicinal ingredient is recalled in Vietnam (Internet image)

Responsibility for recalling drugs in Vietnam

- 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.

Pursuant to: Article 64 of the Law on Pharmacy 2016

Mai Thanh Loi

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