Kommisjonsforordning (EU) 2024/848 av 14. mars 2024 om endring av rådsforordning (EF) nr. 297/95 med hensyn til justering etter inflasjonstakten av gebyrene til Det europeiske legemiddelbyrå med virkning fra 1. april 2024
Inflasjonsjustering av avgifter til Det europeiske legemiddelbyrået (2024)
Commission Regulation (EU) 2024/848 of 14 March 2024 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2024
Kommisjonsforordning publisert i EU-tidende 15.3.2024
Nærmere omtale
BAKGRUNN (fra kommisjonsforordningen)
(1) In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency consists in particular of a contribution from the Union and fees paid by undertakings to that Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.
(2) The fees should be reviewed and updated by reference to the inflation rate of 2023 as published by the Statistical Office of the European Union (3). The inflation rate in the Union was 3,4 % in 2023.
(3) For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.
(4) Regulation (EC) No 297/95 should therefore be amended accordingly.
(5) For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2024.
(6) In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2024. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,