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.

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 €296,500From €148,400
Extension of marketing authorisation (level I)€89,000€37,100
Type-II variation (major variation)€89,000€44,400
Scientific adviceFrom €44,400 to €89,000From €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:

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 the EMA fees query form.

Changes for veterinary medicines in 2022

From 28 January 2022, the Veterinary Medicines Regulation will update existing rules on the authorisation and use of veterinary medicines in the EU. 

EMA has revised its implementing rules to the Fee Regulation to reflect these changes with effect from 28 January 2022. 

The main changes involve:

  • updated references to the legislation, such as article numbers and terminology;
  • revised content in Annex II on fees for applications under new legal bases (limited markets and exceptional circumstances);
  • revised content on variations.

The changes only relate to veterinary medicines, not to medicines for human use. 

The current implementing rules, valid as of 1 April 2021, continue to apply until 28 January 2022. 

Both versions are available under 'Legal documents'. 

Incentives

Previously applicable rules

Topics

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