Registration of anti-Covid vaccines has been extended in Russia » Medvestnik


The procedure for accelerated registration and obtaining approval documents for drugs intended to combat COVID-19 has been extended until January 1, 2025. We are talking about vaccines and some antiviral drugs, the registration of which ends on January 1, 2024. Also, the regime for importing unregistered drugs and medicines in foreign packages into Russia will continue to apply.

The effect of Russian Government Decree No. 441 of 04/03/2020, regulating the specifics of the circulation of medicines intended to combat COVID-19, has been extended until January 1, 2025. The document was signed on November 7 by the Prime Minister Mikhail Mishustin.

The resolution extends the accelerated registration regime for drugs used to treat the new coronavirus infection. In 2020, the first vaccine for the prevention of COVID-19 was registered under this document, then antiviral drugs were registered, for example, favipiravir, molnupiravir, etc. Many of the antiviral drugs subsequently received permanent registration. The vaccines only have temporary registration left, which was valid until January 1, 2024, before the extension of Decree No. 441.

In 2022, the document was amended to allow changes to be made to the temporary registration certificate of the vaccine in order to change the antigenic composition. In August 2023, the Center named after. Gamaleyi received permission for a clinical trial of the updated vaccine. According to the director of the Center Alexandra Ginzburgclinical studies are already close to completion.

In addition to registration, the resolution extended the possibility of importing unregistered drugs into Russia, as well as drugs in foreign packaging. According to the State Register of Medicines (SRLS), such permits were last issued in October 2022.

Also, the period of validity of increased prices is extended for a number of medicines. The first version of Resolution No. 441 included provisions that would allow for higher prices for medications needed to fight COVID-19, which could be in short supply due to low prices. In 2020, six such INNs were found: hydroxychloroquine, sodium heparin, paracetamol, enoxaparin sodium, methylprednisolone and ceftriaxone. Prices did not increase for all items of the listed drugs, but only for individual dosages from several manufacturers. Subsequently, the standard for increasing prices was removed, but for these drugs it is extended separately.



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