in force 2025-01-10 MODIFIED+559 −43§
Amended by Regulation (EU) 2024/1860 32024R1860 · Regulation (EU) 2024/568 32024R0568
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates added to the text: 2022-01-25
Paragraph 14 changes the phrase describing who the fees are payable to, from fees payable to the Commission to fees established under the procedure in paragraph 13, and rewords the cross-reference to Annex IX, Section 5.1, point (c).
Two new paragraphs are added specifying that fees related to advice from expert panels are payable to EMA under Article 30, point (f), of Regulation (EU) 2022/123, and that fees related to advice from expert laboratories are payable to the Commission.
Cited: Art. 106, v1 · Art. 106, v2
text before / after
02017R0745-20240709 → 02017R0745-20250110
Article 106
Provision of scientific, technical and clinical opinions and advice
1. The Commission shall, by means of implementing acts and in consultation with the MDCG, make provision for expert panels to be designated for the assessment of the clinical evaluation in … 1,035 unchanged words … protection of health and safety, support of innovation and cost-effectiveness and the necessity to achieve active participation in the expert panels. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
14. The fees payable to the Commission 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 Section 5.1 (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 CouncilRegulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1)..
The fees related to the advice provided by expert laboratories are payable to the Commission.
15. The Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the tasks of expert panels and expert laboratories referred to in paragraph 10 of this Article.