The European Medicines Agency (EMA) has increased the general, non-pharmacovigilance fees by 0.3 per cent and 5.3 per cent from 1st April, 2022 to reflect the inflation rate adjustments of 2020 and 2021 respectively.
In a statement, EMA said that the new fee levels are available in Commission Regulation (EU) 2022/510 amending Council Regulation (EC) No 297/95, its implementing rules, and the corresponding explanatory note on fees, published on 29th March, 2022. These documents include the new fees for all types of procedures handled by the agency, except for pharmacovigilance procedures.
Every year, the agency adjusts its fees on 1st April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2020 and 2021, as published by Eurostat, the EU’s statistical office, said the statement.
Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised later in 2022, the statement concluded.