Regulatory information – adjusted fees for applications to EMA from 1 April 2023

News 31/03/2023

The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023.

Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2022 inflation rate was 10.4%.

EMA published full details of the revised fees following the adoption of the Commission Regulation (EU) 2023/699 of 29 March 2023 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 2023. The Agency's Management Board decided on the implementation of the regulation at its March 2023 meeting.

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised by the same percentage later in 2023.

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