Medicines with signs of being unsafe for users in Vietnam from February 07, 2025

Tran Thanh Rin

08:00, 26/12/2024

The article below will address medicines showing signs of being unsafe for users in Vietnam from February 7, 2025.

Medicines with Signs of Being Unsafe for Users as of February 7, 2025

Medicines with signs of being unsafe for users in Vietnam from February 07, 2025 (Image from the Internet)

On December 24, 2024, the Minister of Health of Vietnam promulgated Circular 45/2024/TT-BYT amending Circular 11/2018/TT-BYT on regulations concerning medicine quality and raw materials.

Medicines with signs of being unsafe for users in Vietnam from February 07, 2025

According to Clause 3, Article 15a of Circular 11/2018/TT-BYT (supplemented by Circular 45/2024/TT-BYT), the types of medicines showing signs of being unsafe for users from February 7, 2025, include:

- Medicines with reports of adverse reactions that are serious or recurrent related to the medicine but are not known adverse reactions of the medicine;

- Medicines suspected of containing substances or impurities exceeding the safe limit for users;

- Medicines suspected of not meeting quality standards;

- Medicines suspected of being counterfeit, not of original provenance;

- Medicines produced from raw materials of unknown origin or not meeting quality standards;

- Medicines suspected of being produced at manufacturing facilities that seriously violate the principles, standards of Good Manufacturing Practices, or whose production conditions have not been confirmed by the pharmaceutical management agency.

Methods of reporting medicines with signs of being unsafe for users in Vietnam as of February 7, 2025

The methods for reporting medicines with signs of being unsafe for users in Vietnam from February 7, 2025, include:

(i) Official documents from the agencies stipulated at points a, c, and d, Clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented by Circular 45/2024/TT-BYT) sent directly or through official channels to the Ministry of Health or via the electronic document management and administration system of the Ministry of Health.

(ii) Besides the forms specified in (i), official documents from the agencies stipulated at point b, Clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented by Circular 45/2024/TT-BYT) can be sent via email or published on the official website of the agency;

(iii) Complaint petitions, denunciations, or direct presentations at competent agencies as prescribed by law on complaints and denunciations from organizations, individuals stipulated at point d, Clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented by Circular 45/2024/TT-BYT).

It is known that the Ministry of Health (Department of Pharmaceutical Management) receives information accompanied by relevant documentation (if any) for medicines with signs of being unsafe for users from:

- Relevant agencies (including police, customs, market management, inspection, Vietnamese diplomatic missions abroad, foreign diplomatic missions in Vietnam);

- The World Health Organization, foreign pharmaceutical or health regulatory authorities;

- Health Departments of provinces and cities under central authority;

- Centers for Drug Information and adverse drug reaction monitoring;

- Producers, traders, users of medicinal products, and from other agencies, organizations, and individuals.

Thereupon, the Ministry of Health (Department of Pharmaceutical Management) is responsible for handling this information, issuing notifications of temporary suspension of sales, usage, and the sealing for preservation of drugs showing signs of being unsafe for users. Concurrently, it will cooperate with relevant authorities, organizations, and individuals in verifying and issuing conclusions on drug quality and the safety level of drug use.

(Article 15a of Circular 11/2018/TT-BYT (supplemented by Circular 45/2024/TT-BYT)

More details can be found in Circular 45/2024/TT-BYT effective from February 7, 2025.

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