The European Commission proposed a new regulation to revise the fee structure for the fees charged by the European Medicines Agency (EMA) to Marketing Authorisation Holders (MAHs) and applicants for obtaining and maintaining marketing authorisations for both human and veterinary medicinal products. The new regulation will repeal the current fee regulation (Regulation (EC) No 297/95) in addition to the regulation for fees associated with pharmacovigilance activities (Regulation (EC) No 658/2014).
The new regulation aims to simplify the existing fee structure, which has been in place for almost 30 years, and make it ‘more flexible to adapt to future developments’ including the upcoming changes to Veterinary legislation.
Background
The current fees charged by the EMA compensates the EMA for its own regulatory activities as well as National Competent Authorities for their roles in the authorisation process, with fees being increased annually in line with the cost of services and inflation. On 13 December 2022 the European Commission adopted a proposal to repeal the existing fee regulations (Regulation (EC) No 297/95 and Regulation (EC) No 658/2014) and proposed a new regulation.
Since then, there have been additional amendments made to the proposal including a two-step inflation on some fees and an adjustment for seven procedures. The revised document also noted a 13% increase based on inflation rates for 2021 and 2022 which was applied to all the fees. Additionally, the remuneration for National Competent Authorities was increased.
An agreement on the fees regulation between the European Parliament and Council was announced on 25 September 2023. This led to the European Council formally endorsing the text with a view to agreement. The Permanent Representatives Committee approved the proposed text during its meeting on 11 October 2023.
When will the Regulation apply?
The new EMA fee regulation will apply from 01 January 2025 if the European Parliament adopts the agreed text at the first reading. This will mean the act will be fully adopted, however, it would still need to be published in the Official Journal of the European Union and would enter into force the day after that publication.
What are the new fees?
The table below highlights some of the new proposed fees in respect of medicinal products for human use compared with the current fees.
As noted above, the rate of inflation will further affect the rates proposed. The inflation rate for 2023 will be made available in January 2024.
| Fee type (Human medicines) | Current Fee Regulation | New Fee regulation |
| Marketing authorisation application (fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application) | From €345,800 | From €172,800 to €865,200 |
| Extension of marketing authorisation (level I) | €103,800 | From €168,500 |
| Type-II variation (major variation) | €103,800 | From €163,200 |
| Scientific advice | Up to €103,800 | From €51,900 to €98,400 |
| Annual fee | Up to €123,900 | From €60,300 to €232,400 |
| An application for or reassessment of the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000 | Free | €20,000 |
| Paediatric applications in accordance with Regulation (EC) No 1901/2006 | Free | From €9,600 to €38,100 |
| Pharmacovigilance Regulation (EU) No 658/2014 | Up to €332,460 | Up to €367,030 |
Questions?
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