Commission Regulation (EU) 2024/848of 14 March 2024amending 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(Text with EEA relevance)

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 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products OJ L 35, 15.2.1995, p. 1, ELI: http://data.europa.eu/eli/reg/1995/297/oj. , and in particular Article 12, fifth paragraph, thereof, Whereas: (1) In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/726/oj). , 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 https://ec.europa.eu/eurostat/documents/2995521/18343103/2-17012024-AP-EN.pdf/9d885442-f323-cdde-e149-17ed99a63a6f. . 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, HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is amended as follows: (1) Article 3 is amended as follows: (a) paragraph 1 is amended as follows: (i) point (a) is amended as follows: in the first subparagraph, EUR 345800 is replaced by EUR 357600; in the second subparagraph, EUR 34800 is replaced by EUR 36000; in the third subparagraph, EUR 8600 is replaced by EUR 8900; (ii) point (b) is amended as follows: in the first subparagraph, EUR 134100 is replaced by EUR 138700; in the second subparagraph, EUR 223600 is replaced by EUR 231200; in the third subparagraph, EUR 13400 is replaced by EUR 13900; in the fourth subparagraph, EUR 8600 is replaced by EUR 8900; (iii) point (c) is amended as follows: in the first subparagraph, EUR 103800 is replaced by EUR 107300; in the second subparagraph, EUR 26200 to EUR 77900 is replaced by EUR 27100 to EUR 80500;

in the third subparagraph, EUR 8600 is replaced by EUR 8900; (b) paragraph 2 is amended as follows: (i) in point (a), the first subparagraph is amended as follows: EUR 3900 is replaced by EUR 4000; EUR 8600 is replaced by EUR 8900; (ii) point (b) is amended as follows: in the first subparagraph, EUR 103800 is replaced by EUR 107300; in the second subparagraph, EUR 26200 to EUR 77900 is replaced by EUR 27100 to EUR 80500; (c) in paragraph 3, EUR 17000 is replaced by EUR 17600; (d) in paragraph 4, first subparagraph, EUR 26200 is replaced by EUR 27100; (e) in paragraph 5, EUR 8600 is replaced by EUR 8900; (f) paragraph 6 is amended as follows: (i) in the first subparagraph, EUR 123900 is replaced by EUR 128100; (ii) in the second subparagraph, EUR 30800 to EUR 92800 is replaced by EUR 31800 to EUR 96000; (2) in Article 4, first paragraph, EUR 86000 is replaced by EUR 88900; (3) Article 5 is amended as follows: (a) paragraph 1 is amended as follows: (i) point (a) is amended as follows: in the first subparagraph, EUR 173000 is replaced by EUR 178900; in the second subparagraph, EUR 17000 is replaced by EUR 17600; in the third subparagraph, EUR 8600 is replaced by EUR 8900; the fourth subparagraph is amended as follows: EUR 86000 is replaced by EUR 88900; EUR 8600 is replaced by EUR 8900; (ii) point (b) is amended as follows: in the first subparagraph, EUR 86000 is replaced by EUR 88900; in the second subparagraph, EUR 146200 is replaced by EUR 151200; in the third subparagraph, EUR 17000 is replaced by EUR 17600; in the fourth subparagraph, EUR 8600 is replaced by EUR 8900; the fifth subparagraph is amended as follows: EUR 43300 is replaced by EUR 44800; EUR 8600 is replaced by EUR 8900; (iii) point (c) is amended as follows: in the first subparagraph, EUR 43300 is replaced by EUR 44800; in the second subparagraph, EUR 10700 to EUR 32600 is replaced by EUR 11100 to EUR 33700; in the third subparagraph, EUR 8600 is replaced by EUR 8900; (b) paragraph 2 is amended as follows: (i) in point (a), the first subparagraph is amended as follows: EUR 3900 is replaced by EUR 4000; EUR 8600 is replaced by EUR 8900; (ii) point (b) is amended as follows: in the first subparagraph, EUR 51800 is replaced by EUR 53600; in the second subparagraph, EUR 13000 to EUR 39100 is replaced by EUR 13400 to EUR 40400; in the third subparagraph, EUR 8600 is replaced by EUR 8900; (c) in paragraph 3, EUR 8600 is replaced by EUR 8900; (d) in paragraph 4, first subparagraph, EUR 26200 is replaced by EUR 27100; (e) in paragraph 5, EUR 8600 is replaced by EUR 8900; (f) paragraph 6 is amended as follows: (i) in the first subparagraph, EUR 41500 is replaced by EUR 42900; (ii) in the second subparagraph, EUR 10200 to EUR 30800 is replaced by EUR 10500 to EUR 31800; (4) in Article 6, first paragraph, EUR 51800 is replaced by EUR 53600; (5) Article 7(1) is amended as follows: (a) in the first subparagraph, EUR 86000 is replaced by EUR 88900; (b) in the second subparagraph, EUR 26200 is replaced by EUR 27100;

(6) Article 8 is amended as follows: (a) paragraph 1 is amended as follows: (i) in the second subparagraph, EUR 103800 is replaced by EUR 107300; (ii) in the third subparagraph, EUR 51800 is replaced by EUR 53600; (iii) in the fourth subparagraph, EUR 26200 to EUR 77900 is replaced by EUR 27100 to EUR 80500; (iv) in the fifth subparagraph, EUR 13000 to EUR 39100 is replaced by EUR 13400 to EUR 40400; (b) paragraph 2 is amended as follows: (i) in the second subparagraph, EUR 345800 is replaced by EUR 357600; (ii) in the third subparagraph, EUR 173000 is replaced by EUR 178900; (iii) in the fifth subparagraph, EUR 3900 to EUR 298000 is replaced by EUR 4000 to EUR 308100; (iv) in the sixth subparagraph, EUR 3900 to EUR 149200 is replaced by EUR 4000 to EUR 154300; (c) in paragraph 3, first subparagraph, EUR 8600 is replaced by EUR 8900.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2024.

Article 3

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. It shall apply from 1 April 2024. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 14 March 2024. For the Commission The President Ursula von der Leyen