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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  annex_VI

CELEX:  02024R0568-20240214

Performance information The following information relating to each calendar year shall be made publicly available on the Agency’s website:
(1) the overall cost and breakdown of Agency staff and non-staff costs relating to the fees and charges referred to in Article 3;
(2) number of Agency staff involved and the overall costs for obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products and for other services of the Agency;
(3) number of procedures for obtaining and maintaining a Union authorisation to market medicinal products for human use and veterinary medicinal products and for other services of the Agency;
(4) number and amount of fee reductions or waivers granted per type of fee reduction or waiver under Union legislation and number of applicants or holders concerned;
(5) attribution of rapporteurs, co-rapporteurs or persons performing other roles considered as equivalent for the purposes of this Regulation as referred to in the Annexes to this Regulation, per Member State and per type of procedure;
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  annex_VI

CELEX:  02024R0568-20240214

(6) number of working hours spent by the rapporteur, the co-rapporteurs or persons performing other roles considered as equivalent for the purposes of this Regulation as referred to in the Annexes to this Regulation, including hours spent by experts and others employed by the competent authorities of the Member States to assist them, and number of working hours spent by experts contracted for the work of the expert panels on medical devices. Information shall be provided per type of procedure on the basis of the information provided to the Agency by the competent authorities of the Member States concerned. The types of procedure to be included shall be decided by the Management Board based on a proposal by the Agency;
(7) any performance indicators relevant to scientific service fees or charges for administrative services levied in accordance with Article 4(1) and (2) of this Regulation;
(8) any additional relevant key performance indicators that impact the evolving workload of the Agency and competent authorities of the Member States in the Union pharmaceutical regulatory framework, including procedures for the authorisation and supervision of medicinal products.