Fees payable to the European Medicines Agency
This content applies to human and veterinary medicines.
The European Medicines Agency (EMA) charges fees for the services it provides. The rules relating to the Agency's fees are governed by the fee regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee regulation (Regulation (EU) No 658/2014).
The European Commission is currently revising EMA's fees system. For more information, see European Commission: Evaluation of EMA's fee system.
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:
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.
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Decision of the Executive Director on fee reductions for designated orphan medicinal products (PDF/198.26 KB)
Adopted
First published: 23/06/2020
Legal effective date: 19/06/2020
EMA/135645/2020 -
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Decision of the Executive Director on fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector (PDF/115.19 KB)
Adopted
First published: 06/06/2016
Last updated: 06/06/2016
EMA/63484/2016
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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 (PDF/445.33 KB)
First published: 31/03/2023
EMA/MB/622516/2022 -
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Explanatory note on general fees payable to the European Medicines Agency as of 01 August 2022 (PDF/978.2 KB)
First published: 01/08/2022
Legal effective date: 01/08/2022 -
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Explanatory note on general fees payable to the European Medicines Agency as of 01 April 2022 (PDF/830.8 KB)
First published: 01/04/2022 -
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Explanatory note on general fees payable to the European Medicines Agency as of 28 January 2022 (PDF/1.28 MB)
First published: 25/10/2021
Legal effective date: 28/01/2022 -
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Explanatory note on general fees payable to the European Medicines Agency as of 15 July 2021 (PDF/821.78 KB)
First published: 20/07/2021 -
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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 (PDF/418.12 KB)
First published: 01/08/2022
Legal effective date: 01/08/2022
EMA/MB/95162/2022 -
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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 (PDF/417.94 KB)
First published: 01/04/2022