EMA fees: charges under Regulation (EU) 2024/568

Regulation (EU) 2024/568 of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency applies from 1 January 2025. It replaced Regulation (EC) No 297/95, which had set the Agency's fees since 1995, and Regulation (EU) No 658/2014 on pharmacovigilance fees, bringing all EMA fees and charges into one act. Its annexes list the fee for each procedure: initial marketing authorisation applications in the centralised procedure, extensions, Type IA, IB and II variations, renewals, scientific advice, referrals, inspections, PSUR assessments and post-authorisation safety studies, together with the annual fee per authorisation. The same annexes set the remuneration the Agency pays to national competent authorities for the rapporteur and co-rapporteur work they do for its committees.

Fees are payable in euro and are usually invoiced when the application is validated, with the amount due within the period stated on the invoice; an application is not considered valid until the fee question is settled. Reductions and waivers apply for micro, small and medium-sized enterprises under Regulation (EC) No 2049/2005, for orphan medicines, for paediatric applications and for advanced therapy medicinal products, and the Regulation sets the circumstances in which a fee is reduced or deferred. Amounts are adjusted for inflation each year, so the figure that applies is the one in force on the date of submission, not the one in the published text. The Regulation also allows the Commission to amend the annexes by delegated act, for example to add fees for new procedures.

What goes wrong: budgets are built on the old fee schedule and underestimate the annual charge per authorisation; grouped variations and worksharing are costed as if each change were a separate Type II fee, or the reverse; SME status is claimed without the prior EMA declaration that the reduction requires; the variation fee is paid for the wrong category after a classification change; and the fee for a scientific advice request is missed because it is invoiced before the meeting. For a portfolio of centrally authorised products the annual fees alone are a material line, and a transfer of authorisation moves them to the new holder from the transfer date.