The European Medicines Agency (EMA) told Sputnik on Wednesday it would draft a scientific report on Russia's Sputnik V vaccine against the coronavirus, as developers had submitted a relevant request
BRUSSELS (Pakistan Point News / Sputnik - 20th January, 2021) The European Medicines Agency (EMA) told Sputnik on Wednesday it would draft a scientific report on Russia's Sputnik V vaccine against the coronavirus, as developers had submitted a relevant request.
The EMA confirmed to Sputnik that it held consultations with the vaccine developers on Tuesday to discus "possible options for EU approval" and "further engagement with the agency." The agency declined to disclose any details of the conversation for confidentiality reasons.
"The developer has now submitted a request for scientific advice to the Agency. The scientific advice process is a well-established process at EMA, which is available to all companies to facilitate the preparation of their development program. EMA will provide advice to companies taking into account the latest regulatory and scientific guidance. As a next step the application for a marketing authorisation could then be prepared by the company," EMA said.
