"RDIF announces the beginning of the procedure for the sequential examination of the registration dossier (rolling review) of the Russian vaccine against coronavirus Sputnik V by the Committee on Medicines for Medical Use of the European Medicines Agency," the statement said.
As noted, the decision of the committee was made taking into account the results of laboratory and clinical studies of the drug in adults.
The EMA will assess the vaccine's compliance with EU standards for efficacy, safety and quality.
RDIF CEO Kirill Dmitriev welcomed the launch of the procedure.
Sputnik V has the potential to make a critical contribution to saving millions of lives across Europe, and we look forward to reviewing the data by the Medicines for Medical Use committee, ”he said, noting that partnership on this issue must come before politics.
Earlier it was reported that Slovakia became the second country in the EU after Hungary to allow the use of "Sputnik V".