Fees payable to the European Medicines Agency

The European Medicines Agency (EMA) charges fees for the services it provides. As of 1 January 2025, EMA's fees are governed by Regulation (EU) 2024/568. This is known as the 'New fee regulation'. EMA makes regulatory guidance on the new fee regulation available on this website, in the form of questions and answers.

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. A working arrangements document is available below to clarify the regulation, fee reductions, and payment terms.

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

• About us

You can see the history of changes of this page in the dedicated section 'Page update history'

In this section

Guidance for all applicants

Questions and answers on when fees apply, how they are calculated, eligibility for reductions and payment rules

Fees for human medicines

Questions and answers on fees, charges and remuneration for the assessment and services for human medicines

Fees for veterinary medicines

Questions and answers on fees, charges and remuneration for the assessment and services for veterinary medicines

Annual fees

Questions and answers on yearly fees for human and veterinary medicines and pharmacovigilance fees

Other fees and charges

Questions and answers on inspections, transfers, pre-submission requests, re-examinations, certificates, parallel distribution notices, other scientific services and medical devices

How to pay

Information and guidance on invoicing, terms and conditions of payment and how to set up a customer account with EMA

Working arrangements

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.

New fee regulation working arrangements

Reference Number: EMA/MB/183645/2024 Revision 2

Information events

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:

New fee regulation: information events

• Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V) (10/04/2025)
• Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V) (27/03/2025)
• Certificates Processing System: Demo & Q&A session for industry stakeholders (13/03/2025)
• Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders (11/02/2025)
• Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders (10/02/2025)
• Quarterly System Demo - Q4 2024 (12/12/2024)
• New fee regulation: webinar for human industry stakeholders (24/10/2024)
• New fee regulation: webinar for veterinary industry stakeholders (24/10/2024)
• Small and medium-sized enterprises info day (18/10/2024)
• Quarterly System Demo - Q3 2024 (18/09/2024)
• Twelfth meeting of the industry stakeholder platform on research and development support (04/07/2024)
• Quarterly System Demo - Q2 2024 (26/06/2024) - see interval between 6:32 and 19:08 in the video recording available on the event page
• New fee regulation: webinar for veterinary marketing authorisation holders (20/06/2024)
• Third European Medicines Agency and Affordable Medicines Europe bilateral meeting (10/04/2024)
• Quarterly System Demo - Q1 2024 (26/03/2024) - see interval between 02:36:50 and 02:47:30 in the video recording available on the event page
• Eighth Industry Standing Group (ISG) meeting (25/03/2024)

Contacting EMA about fees

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. 

EMA fees query form

Legal framework

• Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency
• 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

Standard operating procedures

Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568

Adopted Reference Number: EMA/78251/2024 Legal effective date: 01/01/2025

Previously applicable rules

Rules applicable before the entry into force of Regulation (EU) 2024/568

Explanatory note on pharmacovigilance fees payable to EMA (as of 4 October 2023)

Reference Number: European Medicines Agency

Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2024

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2024

Reference Number: EMA/MB/182939/2023

 

Other previously applicable rules include: 

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

Page update history

See update history

This update log shows the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

Updates begin in October 2025.

Date	Category	Summary
02/10/2025	Structural changes	Page layout updated