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.
Examples of current basic fees
|Fee type||Human medicines||Veterinary medicines|
|Marketing-authorisation application (single strength, one pharmaceutical form, one presentation)||From €291,800||From €146,100|
|Extension of marketing authorisation (level I)||€87,600||€36,500|
|Type-II variation (major variation)||€87,600||€43,700|
|Scientific advice||From €43,700 to €87,600||From €14,400 to 43,700|
|Annual fee (level I)||€104,600||€35,000|
|Establishment of MRLs||-||€72,600|
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:
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.
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
Commission Regulation (EU) 2019/480 of 22 March 2019 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 2019 (PDF/372.52 KB)
First published: 01/04/2019
Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (PDF/71.23 KB)
First published: 25/03/2011
Last updated: 25/03/2011
Decision of the Executive Director on a 1-year initiative for fee reductions for notifications of parallel distribution (PDF/264.13 KB)Adopted
First published: 21/07/2017
Last updated: 13/04/2018
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
Fee reductions for designated orphan medicinal products (PDF/113.67 KB)
First published: 24/02/2011
Last updated: 14/01/2015
Legal effective date: 01/01/2013
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
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
Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2018 (PDF/1013.9 KB)
First published: 28/03/2018
Last updated: 28/03/2018
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 2018 (PDF/295.9 KB)Adopted
First published: 16/03/2018
Last updated: 16/03/2018