EU regulator makes no comment on possible trips of inspectors to Russia

World October 08, 2021, 19:53

The Sputnik V coronavirus vaccine has not yet been authorized by EMA for use on the territory of the European Union

THE HAGUE, October 8. /TASS/. The European Medicines Agency (EMA) is not a position at this stage to comment on possible trips of inspectors to Russia, the EMA press office told TASS on Friday, responding to the request for comment on information of the Russian Ministry of Health that EMA representatives can visit Russia in December 2021.

"In the context of the evaluation of the Sputnik V vaccine, European inspectors carried out Good Clinical Practice (GCP) inspections and Good Manufacturing Practice (GMP) inspections in Russia in April and May 2021," the Press Office said. "As new information is submitted by the applicant during the rolling review, further inspections may be needed. While the evaluation of a COVID-19 vaccine is ongoing we cannot comment further on planned or ongoing inspections," it noted.

"Information on inspections will be included in the final assessment report which will be published on our website at the time of EMA’s recommendation on the marketing authorization, if an application is received," the Press Office added.

The Sputnik V coronavirus vaccine has not yet been authorized by EMA for use on the territory of the European Union.

Read more on the site →