The European Medicines Agency (EMA) introduced a new fee system on 1 January 2025 to cover the costs of service provision for veterinary medicines, which were previously subsidised. The new fee structure aims to simplify the existing system, align fees with service costs, ensure that remuneration covers both EMA and national competent authorities’ (NCA) costs and provide future sustainability for the EMA’s pharmacovigilance systems.

This article outlines the impact of these changes on marketing authorisation holders (MAHs), including those supplying veterinary medicines nationally without a centralised marketing authorisation. The EMA fees are underpinned by Regulation (EU) 2024/568, which was adopted after extensive evaluation and consultation with stakeholders. The new fees include charges for new applications, annual maintenance and pharmacovigilance, with specific provisions for small and medium-sized enterprises. The article also discusses the consequences for products marketed only in one Member State and the implications of referral procedures.