Regulatory information – 0.3% and 5.3% increase in general fees from 1 April 2022
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General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 0.3% and 5.3% as of 1 April 2022, to reflect the inflation rate adjustments of 2020 and 2021 respectively.
Full details of the new fee levels are available in Commission Regulation (EU) 2022/510 of 29 March 2022 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2022 amending Council Regulation (EC) No 297/95, its implementing rules, and the corresponding Explanatory note on general fees payable to the European Medicines Agency as of 01 April 2022, published on 29 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 1 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.
All applications received by 31 March will be charged the current fee and reduction rates. Applications received after that date will be charged the adjusted fees. For scientific advice and protocol assistance, the cut-off point will be the date of validation of the request for advice. For annual fees, the anniversary date of the decision granting the marketing authorisation defines the applicable fee and consequently, a new fee will be applicable at the time of any anniversary on or after 1 April 2022.
Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised later in 2022.