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Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95

article  12

CELEX:  02024R0568-20240214

Estimate of the Agency’s budget The Agency shall, when producing an estimate of revenue and expenditure for the following financial year in accordance with Article 67(6) of Regulation (EC) No 726/2004, include detailed information on income from each type of fee and charge and on the corresponding remuneration. In accordance with the typology of fees and charges set out in Article 3 of this Regulation, that information shall distinguish between the following:
(a) medicinal products for human use and consultations on medical devices;
(b) veterinary medicinal products;
(c) annual fees, by type;
(d) other fees and charges, by type. The Agency may provide a breakdown by type of procedure in an annex to the single programming document produced in accordance with Article 32(1) of Delegated Regulation (EU) 2019/715.