New fee regulation applicable from 1 January 2025

The new legislation harmonises the Agency’s fee structures – unchanged since their enactment – by introducing simplified fees and incentives to enhance regulatory flexibility and transparency.

For the veterinary sector, the regulation introduces several changes, including the reduction and/or removal of certain fees, the introduction of an annual pharmacovigilance fee and new fees for pre-submission activities, referrals, and re-examinations. 

The Agency has published a dedicated webpage on the new fee regulation with comprehensive supporting materials, including:

• the working arrangements document, to support the application of the regulation;
• Q&A documents with clarifications relevant to the veterinary sector (please see annexes 2 and 3), including applicable reductions and an explanation of veterinary chargeable units;
• recordings and presentations shared at the two vet-oriented webinars hosted in June and October 2024.

We strongly recommend consulting the guidance available before requesting further information via nfr@ema.europa.eu.