EMA Fees See 1.7% Increase

Regulatory NewsRegulatory News | 01 April 2019 |  By 

From Monday, all general fees payable to the European Medicines Agency (EMA) will be subject to a 1.7% increase compared to those received by 31 March, as part of alignment with the EU’s 2018 inflation rate.

The 1.7% increase applies to applicants’ and marketing authorization holders’ general fees payable to EMA. It brings the previous basic fee of €286,900 ($321,774) up to €291,800 ($327,269) on a new application for which the presentation of a full dossier is needed, and up to €188,700 ($211,637) from €185,500 ($208,048) on a new application for which a full dossier does not need to be presented.

The adjusted procedural fees are also applicable to all basic extensions of marketing authorizations (level I), type II or major variations to marketing authorizations, requests for scientific advice, annual fees (level I), as well as applications to set initial, modified and extended maximum residue limits for medicinal products for veterinary use.

Validation dates and marketing authorization anniversary dates determine the applicable new fees for scientific advice and annual fees, respectively.

EMA’s new explanatory note also clarified how micro, small and medium-sized enterprises can access total or partial exemptions from payment of fees for certain post-authorization regulatory consultancies.

The agency adjusts its procedural fees on 1 April of every year in line with the EU’s inflation rate for the previous year. The April 2018 fee increase totaled 1.7% as well. EMA’s pharmacovigilance fees are separately adjusted to account for inflation rates, with the latest increase also being 1.7% last October. EMA said last month that pharmacovigilance fees will be revised in 2020 to reflect inflation across 2018 and 2019.

To evaluate EMA’s fee system, the European Commission launched a consultation in May 2018.

Explanatory note on general fees payable to the European Medicines Agency

To learn more about the EU regulations for pharmaceuticals, medical devices and other products, join us in Brussels, 13-14, May at the RAPS Regulatory Conference Europe.


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Tags: EMA, EU, Fees

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