Format for disseminating information on drugs with signs of being unsafe for users in Vietnam from February 7, 2024

Format for disseminating information on drugs with signs of being unsafe for users in Vietnam from February 7, 2024

Circular 45/2024/TT-BYT has added Article 15a following Article 15 of Circular 11/2018/TT-BYT regarding the temporary suspension of the business, use, and sealing storage of drugs exhibiting signs of being unsafe for use. The format for disseminating information on drugs with signs of being unsafe for users in Vietnam are as follows:

- Official documents from the authorities specified at points a, c, and d of clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented in clause 8, Article 1 of Circular 45/2024/TT-BYT), sent directly or via postal mail to the Ministry of Health or through the electronic document management and operation system of the Ministry of Health of Vietnam;

- Besides the forms specified at point a, clause 2, Article 15a of Circular 11/2018/TT-BYT (supplemented in clause 8, Article 1 of Circular 45/2024/TT-BYT), official documents from the authorities specified at point b, clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented in clause 8, Article 1 of Circular 45/2024/TT-BYT) can be sent via email or posted on the official electronic information page of the agency;

- Complaints, denunciations, or direct presentations at competent authorities following legal regulations on complaints and denunciations from agencies, organizations, and individuals specified at point dd, clause 1, Article 15a of Circular 11/2018/TT-BYT (supplemented in clause 8, Article 1 of Circular 45/2024/TT-BYT).

Additionally, regarding the authorities receiving information about drugs showing signs of being unsafe for use, the Ministry of Health of Vietnam (Drug Administration Department) receives information along with related documents (if any) for drugs showing signs of being unsafe for use from:

- Functional agencies (including police, customs, market surveillance, inspection, Vietnamese diplomatic agencies abroad, foreign diplomatic agencies in Vietnam);

- The World Health Organization, foreign drug regulatory agencies, or foreign health regulatory agencies;

- Health Departments of provinces and centrally-managed cities;

- Drug Information and Adverse Drug Reaction Monitoring Centers;

- Drug manufacturing, trading, and usage organizations and from other agencies, organizations, and individuals.

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

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