Fees payable to the European Medicines Agency

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The European Medicines Agency 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).  

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 typeHuman medicinesVeterinary medicines
Marketing-authorisation application (single strength, one pharmaceutical form, one presentation)From €278,800From €139,600
Extension of marketing authorisation (level I)€83,700€34,900
Type-II variation (major variation)€83,700€41,800
Scientific adviceFrom €41,800 to €83,700From €13,800 to 41,800
Annual fee (level I)€100,000€33,400

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:

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 this query form

Table of contents


Explanatory note on fees

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Document(s) Language Status First published Last updated Effective Date
Explanatory note on general fees payable to the European Medicines Agency as of 1 June 2016 (English only)   06/06/2016    

Legal documents

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Incentives

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Standard operating procedures

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Previously applicable rules

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