Representatives of Russia's Health Ministry present file on authorization of Sputnik V vaccine in Moldova
17:56 | 04.03.2021 Category: Social
Chisinau, 4 March /MOLDPRES/ - The Medicines and Medical Devices Agency (AMDM) today informed that the file on the authorization of the Gam-COVID-Vac (Sputnik V) vaccine had been presented by the legal representative of the State Federal Budgetary Institution of Russia, National Research Centre for Epidemiology and Microbiology of the Academician N.F. Gamaleya of Russia’s Ministry of Health.
According to a press release issued by AMDM, all anti-COVID vaccines, including Sputnik V, are authorized conditioned.
„None vaccine is pre-qualified by the World Health Organization (WHO) – the goal of the procedure of WHO pre-qualification is to evaluate whether the medicines are safe, meet the conditions recommended by WHO and are manufactured in accordance with the present good practice of fabrication, as well as have finished clinic studies, being authorized through standard procedure. The vaccines Pfizer/BioNTech and AstraZeneca (the platforms SK Bioscience Co. Ltd., Korea and Serum Institute of India Pvt. Ltd, India), included by WHO in EUL (Emergency Use Listing) were authorized conditioned based on a request by the Health, Labour and Social Protection Ministry (MSMPS). AMDM got access to the files based on the agreement on cooperation with WHO,’’ the communiqué reads.
The same document also reads that the file of the Gam-COVID-Vac (Sputnik V) vaccine was presented to AMDM by the legal representative of the State Federal Budgetary Institution of Russia, National Research Centre for Epidemiology and Microbiology of the Academician N.F. Gamaleya of Russia’s Ministry of Health.
All documentation on the quality, inoffensiveness and efficiency of the concerned vaccine was assessed by specialists in the field and discussed at a meeting of the Commission for Medicine. Additionally, certificates of registration from over 20 countries were presented in the file, as compulsory part, among which Hungary, EU member country and the Hungarian institution is emergency regulation authority, which is obliged by WHO to enforce the strict standards of quality, safety and efficiency in its process of regulation in the medicines and vaccines sector, for authorizing of introduction on market.