In which cases are medicines and medicine ingredients in Vietnam recalled?

In which cases are medicines and medicine ingredients in Vietnam recalled?​​ (Illustrative photo)

Article 62 of the Law on Pharmacy 2016 specifically stipulates the cases of medicine and medicine ingredient recalls in Vietnam as follows:

Medicines in Vietnam are recalled in the following cases:

- Not belonging to the category permitted for circulation according to regulations;

- The medicine registration certificate is revoked in the following cases:

+ The medicine is recalled due to Level 1 violations;

+ Within 60 months, there are 02 batches of Medicines mandatorily recalled due to Level 2 violations or 03 or more batches of medicines with quality violations;

+ The medicine registration certificate, medicine ingredient registration certificate was issued based on falsified documents;

+ Medicines, medicine ingredients produced not in accordance with the registered address;

+ Active pharmaceutical ingredients, medicinal materials, or medicines containing active pharmaceutical ingredients, medicinal materials that the World Health Organization, competent management agencies of Vietnam, or the drug's country of origin recommend as unsafe or ineffective for users;

- Failing to meet the requirements stipulated in Clause 4, Article 54 or Clause 2, Article 59 of this Law;

- Medicines failing to meet quality standards, medicines produced from medicine ingredients not meeting quality standards;

- Conclusion of a competent state agency regarding medicines not meeting safety, efficacy requirements;

- Medicines without evidence of quality inspection during production and before release;

- There is a recall notice from foreign pharmaceutical management agencies.

Medicine ingredients circulating on the market in Vietnam are recalled in the following cases:

- Medicine ingredients are misused;

- The medicine ingredient circulation registration certificate is revoked in cases stipulated at Points d, dd, and e, Clause 1, Article 58;

- Failing to meet the requirements stipulated in Clause 4, Article 54 or Clause 3, Article 59;

- Medicine ingredients not meeting quality standards for medicine production; medicine ingredients not matching the registered source or import permit;

- Medicine ingredients without evidence of quality inspection during production and before release;

- There is a recall notice from foreign pharmaceutical management agencies.

For details, refer to Law on Pharmacy 2016 effective from January 01, 2017.

Ty Na

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