Fees payable to the European Medicines Agency

This content applies to human and veterinary medicines.

The Regulation (EU) 2024/568 on fees and charges payable to EMA entered into force on 1 January 2025. 

For more information on what EMA is and does, see: 

• About us

• How to pay

A working arrangements document is available to:

• clarify the requirements and terminology of the new regulation;
• establish fee reductions for certain types of services;
• provide further details on payment modalities.

EMA's Management Board adopted these working arrangements in June 2024.

• Commission Regulation (EC) No 2049/2005 on rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
• Regulation (EC) No 141/2000 on orphan medicinal products
• Regulation (EC) No 1901/2006 on medicinal products for paediatric use
• Regulation (EC) No 1394/2007 on advanced therapy medicinal products
• Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices

Information and guidance on invoicing, terms and conditions of payment and how to set up a customer account with the Agency can be found on our How to pay page.

For general queries on fees such as composition and types of fee, fee prices, fee codes, application numbers and procedures, submit the EMA fees query form.

Dynamic forms, such as the 'EMA fees query form' below, do not open in your browser. As a workaround, please download the file on your computer and open it using the PDF desktop app. 

Select the expandable panel below to access a list of events that EMA organised in order to provide useful materials on implementing the New fee regulation:

Other previously applicable rules include: 

• Pharmacovigilance Fee Regulation (Regulation (EU) No 658/2014)
• Council Regulation (EC) No 297/95