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 €296,500 | From €148,400 |
| Extension of marketing authorisation (level I) | €89,000 | €37,100 |
| Type-II variation (major variation) | €89,000 | €44,400 |
| Scientific advice | From €44,400 to €89,000 | From €14,600 to 44,400 |
| Annual fee (level I) | €106,300 | €35,600 |
| Establishment of MRLs | - | €73,800 |
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 note:
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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Commission Regulation (EU) 2020/422 of 19 March 2020 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 2020 (PDF/506.65 KB)
First published: 01/04/2020 -
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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 12 June 2020 (PDF/460.32 KB) (new)
Adopted
First published: 15/06/2020
EMA/MB/238467/2020 Rev. 1
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Decision of the Executive Director on fee reductions for designated orphan medicinal products (PDF/198.26 KB) (new)
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 Good Manufacturing Practice (GMP) on-site inspections due to COVID-19 pandemic (PDF/109.59 KB)
Adopted
First published: 14/05/2020
EMA/225719/2020 -
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Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19 (PDF/109.91 KB)
Adopted
First published: 19/03/2020
EMA/134143/2020 -
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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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Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (PDF/103.98 KB)
Adopted
First published: 16/09/2014
Last updated: 14/12/2018
Legal effective date: 18/12/2014
EMA/308411/2014 -
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Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - First version (PDF/252.6 KB)
Adopted
First published: 22/12/2014
Last updated: 22/12/2014
EMA/CVMP/388694/2014
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Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2020 (PDF/888.69 KB)
First published: 01/04/2020 -
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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 2020 (PDF/453.48 KB)
First published: 20/03/2020
EMA/MB/332998/2019 -
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Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2019 (PDF/677.27 KB)
First published: 01/04/2019 -
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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 2019 (PDF/301.18 KB)
First published: 22/03/2019
EMA/MB/909612/2019