Ministry of Health licensed 03 drugs containing Molnupiravir domestically produced

The Director of the Drug Administration of Vietnam (Ministry of Health) has just issued Decision 69/QD-QLD dated February 17, 2022, promulgating a list of 03 drugs containing Molnupiravir produced in the country, granted circulation registration certificates in Vietnam.

Ministry of Health licensed 03 drugs containing Molnupiravir domestically produced

Ministry of Health licensed 03 drugs containing Molnupiravir domestically produced (Illustration image)

Specifically, 03 domestically produced drugs are licensed, including:

- Molravir 400, content of Molnupiravir 400 mg, hard capsule form, shelf life of 6 months, manufactured by Boston Pharmaceutical Joint Stock Company Vietnam.

- Movinavir, content of 200 mg Molnupiravir, in hard capsule form, shelf life of 6 months, manufactured by Mekophar Pharmaceutical Joint Stock Company.

- Molnuporavir Stella 400, content of 400 mg Molnupiravir, hard capsule form, shelf life of 8 months, produced by Stellapharm Joint Venture Company Limited - branch 1.

The licensing for the above drugs is valid for 3 years from February 17, 2022.

In addition, the Drug Administration of Vietnam requires manufacturing facilities and drug registration establishments to be responsible for manufacturing according to the dossiers and documents registered with the Ministry of Health and must print the registration number issued by the Ministry of Health. drug labels;

At the same time, coordinate with treatment facilities to strictly comply with current regulations on prescription drugs, monitor the safety, effectiveness, and unwanted effects of drugs on Vietnamese people, and synthesize and report according to regulations. regulation.

(See also responsibilities of manufacturers and drug registration establishments in Appendix 2 issued with Decision 69/QD-QLD ).

The Department also requested the Departments of Health of the provinces and centrally-run cities to notify the medical examination and treatment facilities, medical staff, and drug supply establishments in the locality to inform patients of the benefits and risks. risks when using drugs, treatments, other drugs that can replace Molnupiravir in the treatment of COVID-19.

Strengthen monitoring, surveillance, detect cases of adverse drug reactions (if any), send reports of adverse drug reactions to:

+ National Center for drug information and monitoring of adverse drug reactions (Hanoi); or

+ Regional center for drug information and monitoring of adverse drug reactions (Ho Chi Minh City) according to regulations.

In the course of drug circulation, based on monitoring and updating information on the safety and effectiveness of the three drugs above, the Drug Administration of Vietnam shall report to the Advisory Council to issue a certificate of registration of drug circulation, and medicinal materials – The Ministry of Health shall decide to revoke this granted circulation registration in accordance with the provisions of Clause 1, Article 58 of the Law on Pharmacy.

Decision 69/QD-QLD takes effect from February 17, 2022.

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