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 2024.
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 2023 inflation rate was 3.4%.
EMA published full details of the revised fees following the adoption of the Commission Regulation (EU) 2024/848 of 14 March 2024 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 2024. The Agency's Management Board decided on the implementation of the regulation at its March 2024 meeting.
Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 will not be revised in 2024 due to the implementation of Regulation (EU) 568/2024 coming into effect on 1 January 2025.