On Monday 3 April, the European Medicines Agency (EMA) highlighted that the adjustment of fees for applications made by applicants for, or holders of, European market authorisations for pharmaceutical products, with the exception of fees charged for pharmacovigilance procedures, came into force on 1 April.
These adjustments follow the adoption by the European Commission on Wednesday 29 March of Regulation EU/2023/699 on the adjustment of fees payable to the European Medicines Agency on the basis of the inflation rate in the European Union for the previous year, i.e. an adjustment of fees of 10.4%.
The EMA Management Board had adopted decisions on the implementation of this Regulation at its meeting on 15 March.
Fees charged for pharmacovigilance procedures under Regulation EU/658/2014 should be revised to the same percentage “by 2023 at the latest”, the EMA says.
In parallel, legislative work on a revision of the system of fees and charges payable to the EMA has been initiated by the European Commission in order to simplify the system of fees and charges, to make the financing of the Agency's activities more sustainable by basing them on costs and, lastly, to enable the EMA to finance the new tasks entrusted to it, in accordance with the strengthening of the Health Union following the Covid-19 pandemic (see EUROPE 13049/19).
The European Commission’s proposal (see EUROPE 13084/26) is under negotiation in the EU Council and the European Parliament. Both institutions are preparing their respective negotiating positions (see EUROPE 13154/5). According to several stakeholders, the legislative process could be finalised during this term.
Link to the regulation: https://aeur.eu/f/666
Link to the rules for implementing the Regulation: https://aeur.eu/f/664 (Original version in French by Emilie Vanderhulst)