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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 14 CELEX: 02024R0568-20240214 Amendment to Regulation (EU) 2017/745
In Article 106 of Regulation (EU) 2017/745, paragraph 14 is replaced by the following:
‘14. The fees established in accordance with the procedure under paragraph 13 of this Article shall be set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced in the case of a clinical evaluation consultation procedure initiated in accordance with Section 5.1, point (c), of Annex IX involving a manufacturer who is a micro, small or medium-sized enterprise within the meaning of Recommendation 2003/361/EC.
The fees related to the advice provided by expert panels are payable to EMA pursuant to Article 30, point (f), of Regulation (EU) 2022/123 of the European Parliament and of the Council ().
The fees related to the advice provided by expert laboratories are payable to the Commission. |