[ad_1]
According to a statement from an EU agency based in The Hague, despite complaints made several times, the Russian vaccine developer has not requested that a coronavirus vaccine be marketed in the EU.
The agency, which acts as the EU pharmacovigilance authority, reported that developers have so far received scientific advice from the EMA, which provides them with the latest regulatory and scientific guidance for vaccine development. It was also reported that Russian developers have expressed the need to initiate a continuous review process of their coronavirus vaccine.
However, the EMA emphasized that the ongoing review process is reserved for the most promising drugs and vaccines.
The consent of the EMA Committee for Medicinal Products for Human Use (CHMP) and the Coronavir Epidemic Working Group (Covid-ETF) is required for developers to request a review procedure.
It was stated that the EMA will always post when the agency receives a request from Iran for developers to review and begin the evaluation. Likewise, it will be published if the Agency has received a formal marketing request.
The Russian Direct Investment Fund (RFPI), which finances the development of Russian vaccines, announced on Tuesday that it had submitted a registration application for the Sputnik V vaccine against Covid-19 disease to the European Medicines Agency (EMA).
“On January 29, 2021, the RFPI applied for the registration of the Sputnik V vaccine in the European Union and initiated the transfer of information to the EMA through a process of continuous review,” the Russian sovereign wealth fund said in a statement.
The European Commission has previously announced that the European Medicines Agency is in preliminary negotiations with the maker of the Russian coronavirus vaccine, Sputnik V, but the Russian company has not yet decided to apply for EU approval.
Cover image: Getty Images
[ad_2]
