Sputnik V’s producers finalizing work on documents for jab’s approval in EU
The coordination of the dates of the inspection visit by the EMA specialists to the enterprises is underway, the visit is being prepared this year
MOSCOW, October 21. /TASS/. The manufacturers of Russia’s Sputnik V vaccine against coronavirus are wrapping up the preparation of additional documents for the jab’s approval in the EU. The dates of the anticipated visit of the representatives of the European Medicines Agency (EMA) to Russia are being coordinated and the visit is planned for this year, Assistant to the Minister of Health of Russia Alexey Kuznetsov told journalists on Thursday.
"The production sites are currently in the process of finalizing the additional requested documents required to complete the European Health Agency’s certification process. The coordination of the dates of the inspection visit by the EMA specialists to the enterprises is underway. We are preparing the visit this year," he said.
Earlier, Reuters, citing its sources, reported that the EMA may conduct the review of Russia’s Sputnik V jab in the first quarter of 2022, if it receives the data that is lacking before the end of November. It was also noted that if the necessary information is submitted to the regulator by that time, "then the regulators may well decide in the first quarter of next year."
"We would like to urge the public to rely on the official position of the regulators and not on the opinion of various anonymous sources," the health official added.