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.
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 €357,600 | From €173,00 |
| Extension of marketing authorisation (level I) | €107,300 | - |
| Type-II variation (major variation) | €107,300 | - |
| Variations requiring assessment | - | From €8,900 |
| Scientific advice | From €53,600 to €107,300 | From €17,600 to 53,600 |
| Annual fee (level I) | €128,100 | €42,900 |
| Establishment of MRLs | - | €88,900 |
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:
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.
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.