(fra kommisjonsforordningen)

(1) In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council, the revenue of the European Medicines Agency (‘the Agency’) consists of, among other things, a contribution from the Union and fees and charges paid by undertakings to the Agency. Regulation (EU) 2024/568 lays down the categories and levels of the fees and charges levied by the Agency and the remuneration payable by the Agency to the competent authorities of the Member States. 

(2) The monitoring of the 2025 inflation rate leads to the conclusion that the fees, charges and the renumeration require an adjustment to take account of significant changes in costs. On this basis, the fees, charges and remuneration in Annexes I to IV to Regulation (EU) 2024/568 should be adjusted by reference to the annual inflation rate of 2025. The annual inflation rate in the Union, as published by the statistical office of the European Union (Eurostat) on 19 January 2026, was 2,3 % in 2025. 

(3) The amounts in Annexes I to IV to Regulation (EU) 2024/568 already reflected the forecasts of the inflation rates for 2023 and 2024. In this respect, recital 31 in that Regulation stipulates that the first adjustment due to inflation should also take into account the correction needed in view of the final annual inflation rate for 2023 and 2024. On this basis, the fees, charges and remuneration in Annexes I to IV to Regulation (EU) 2024/568 should be also adjusted in view of the final annual inflation rates of 3,4 % for 2023 and 2,7 % for 2024. 

(4) For veterinary medicinal products, the amounts in Annex II to Regulation (EU) 2024/568 were calculated using 50 % of the final annual inflation rates for 2021 and 2022 and 50 % of the forecast inflation rate for 2023. Accordingly, the amounts in Annex II to Regulation (EU) 2024/568 should be adjusted to reflect 50 % of the final annual inflation rate for 2023. 

(5) For clarity and administrative simplicity, the adjusted fees, charges and remuneration in Annexes I to IV to Regulation (EU) 2024/568 should be rounded, for amounts lower than EUR 10 000, to the nearest EUR 10, and for amounts equal to or higher than EUR 10 000, to the nearest EUR 100. Annexes I to IV to Regulation (EU) 2024/568 should therefore be amended accordingly. 

(6) For reasons of legal certainty, this Regulation should not apply to valid annual fees, procedures or services for which the amount became due before 1 January 2027.

(7) In accordance with Article 10(6) of Regulation (EU) 2024/568, any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with that Regulation is to become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place.