EU regulator makes no comment on outcomes of Sputnik V inspections in Russia

Society & Culture January 11, 2022, 20:16

Detailed information will be included in the EMA final assessment report, the agency informed

THE HAGUE, January 11. /TASS/. The European Medicines Agency (EMA) is not in a position to comment on outcomes of inspections in Russia within the framework of Sputnik V coronavirus vaccine assessment, the EMA press office told TASS on Tuesday.

"In the context of the evaluation of the Sputnik V vaccine, European inspectors have carried out Good Clinical Practice (GCP) inspections and Good Manufacturing Practice (GMP) inspections in Russia throughout 2021. While an evaluation is ongoing, EMA cannot comment on the information reviewed (including on the outcome of the inspections)," EMA said.

"Detailed information about the review including any inspections carried out will be included in the EMA final assessment report. This report will be published on the EMA website once the assessment is concluded," the press office of EMA noted.

EMA is currently implementing the expert review of the Sputnik V vaccine, providing in particular for information verification in the course of its receipt from the producer.

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