Recital (3) · Commission Implementing Regulation (EU) 2024/2699

(3)The exchange of information should include the exchange of information for the planning and forecast of the joint clinical assessments and joint scientific consultations. The exchange of that information is necessary for establishing and amending the annual work programme to be adopted by the Coordination Group that is to set out the planned number and type of joint clinical assessments and their updates and the planned number of joint scientific consultations. Pursuant to Article 6(3), points (a) and (b), of Regulation (EU) 2021/2282, in the preparation or amendments of the annual work programme, the Coordination Group is to take into account the reports on emerging health technologies referred to in Article 22 of Regulation (EU) 2021/2282 and information from the European Medicines Agency on the status of submitted and upcoming marketing authorisation applications for medicinal products referred to in Article 7 thereof. Pursuant to Article 22(2), point (b), of Regulation (EU) 2021/2282, the relevant sources for the preparation of the reports on emerging health technologies are to include information by the European Medicines Agency in relation to upcoming submissions of applications for marketing authorisation for medicinal products referred to in Article 7(1) thereof. The Commission should therefore set deadlines to ensure that the relevant information is provided by the European Medicines Agency to the HTA secretariat in a timely manner for the preparation of the reports on emerging health technologies and the work programme. The Coordination Group should, via the HTA secretariat, receive from the European Medicines Agency other available information related to the forecast of the joint clinical assessments and joint scientific consultations necessary for the preparation of the reports on emerging health technologies in accordance with Article 22 of Regulation (EU) 2021/2282. The Commission should therefore specify which information and within which deadlines should be submitted by the European Medicines Agency.