Sputnik V vaccine submitted for registration in the EU
The Sputnik V vaccine is registered in Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay and Turkmenistan
/NOVOSTIVL/ RDIF has applied for registration of the Sputnik V vaccine in the EU and expects the rolling review process to begin in February, the fund said today. Obtaining registration means that the Russian vaccine will be allowed for use in the EU countries.
Yesterday, experts representing the European Medicines Agency (EMA) held a scientific review for the developers of the Sputnik V vaccine, the RDIF noted today. In fact, the first consultations were held before the start of the registration process, in which more than 20 international experts and scientists took part.
Recommendations based on the results of yesterday's discussion will be sent to the developers of the Sputnik V vaccine within 7-10 days, the RDIF notes. As for the decision of the European Medicines Agency to grant Sputnik V registration, it will be made following a series of expert reviews.
Earlier, the Russian Ministry of Health reported that the procedure for registering a Russian medicine or vaccine abroad includes, among other actions, a mandatory examination of production sites - which is difficult in a pandemic and can lengthen the procedure.
On January 22, the World Health Organization (WHO) will begin the pre-submission review of the Sputnik V registration application.