This content applies to human and veterinary medicines.
REGULATION (EU) 2024/568 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees and charges payable to the European Medicines Agency, (the New Fee Regulation) has been published in the EU Official Journal following final adoption by the European Parliament and the Council. The Regulation will become applicable as of 1 January 2025. For more information, see European Commission: 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.
Fees for marketing authorisations
The Agency charges fees for applications for marketing authorisation, and for variations and other changes to marketing authorisations, as well as annual fees for authorised medicines.
Examples of current basic fees
Fee type | Human medicines | Veterinary medicines |
---|---|---|
Marketing-authorisation application (single strength, one pharmaceutical form, one presentation) | From €345,800 | From €173,00 |
Extension of marketing authorisation (level I) | €103,800 | - |
Type-II variation (major variation) | €103,800 | - |
Variations requiring assessment | - | From €8,600 |
Scientific advice | From €51,800 to €103,800 | From €17,000 to 51,800 |
Annual fee (level I) | €123,900 | €41,500 |
Establishment of MRLs | - | €86,000 |
Fees are adjusted every year for inflation.
Fee reductions and incentives are available for micro, small and medium-sized enterprises (SMEs), designated orphan medicines, multiple applications on usage patent grounds and other classes of application.
Full details on all fees and fee reductions are available in the explanatory notes:
Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2023
Fees for human pharmacovigilance
Pharmacovigilance activities conducted at EU level for human medicines are financed by fees paid by marketing-authorisation holders. For further information regarding Pharmacovigilance fees payable to the Agency, please visit the pharmacovigilance fees page.
Paying your fees
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.
Contacting the Agency 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.
EMA fees query form
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 May 2023
Incentives
Decision of the Executive Director on fee reductions for designated orphan medicinal products
Decision of the Executive Director on fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector
Standard operating procedures
Standard operating procedure for processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95
Previously applicable rules
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 2023
Explanatory note on general fees payable to the European Medicines Agency as of 01 August 2022
Explanatory note on general fees payable to the European Medicines Agency as of 01 April 2022
Explanatory note on general fees payable to the European Medicines Agency as of 28 January 2022
Explanatory note on general fees payable to the European Medicines Agency as of 15 July 2021
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 August 2022
Commission Regulation (EU) 2022/510 of 29 March 2022 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2022