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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  11

CELEX:  02024R0568-20240214

Revision
1. The Commission is empowered to adopt delegated acts in accordance with Article 13 to amend the Annexes where justified in view of any of the following:
(a) a special report received by the Commission in accordance with Article 10(7);
(b) the findings from the monitoring of the inflation rate referred to in Article 10(6); or (c) the budgetary reporting of the Agency.
2. Any revision of the fees and charges and of the remuneration paid to competent authorities of the Member States provided for in this Regulation shall be based on the Commission’s evaluation of the Agency’s costs and revenues and of the full costs of the services provided to the Agency within the scope of this Regulation by the competent authorities of the Member States, taking into account also the impact of such services on the sustainability of the operations of the Agency, including the services provided to the Agency by the competent authorities of the Member States, and a fair and objective allocation of fees, charges and remuneration.
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  11

CELEX:  02024R0568-20240214

The Commission may take into account any factors that could have a substantive impact on the Agency’s costs, including but not limited to the workload associated with its activities, and potential risks related to fluctuations in its fee revenue. The fees and charges shall be set at a level which ensures that the Agency has sufficient revenue to cover the costs of the services delivered.
3. In any revision of the Annexes, the amounts of remuneration paid to competent authorities of the Member States provided for in this Regulation shall be maintained as a single amount of remuneration irrespective of the Member State of the competent authority concerned.