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1. The Coordination Group shall adopt each year, at the latest by 30 November, an annual work programme and subsequently amend it if necessary.

2. The annual work programme shall set out the joint work to be carried out in the calendar year following its adoption, covering:

(a) the planned number and type of joint clinical assessments, and the planned number of updates of joint clinical assessments according to Article 14;

(b) the planned number of joint scientific consultations;

(c) the planned number of assessments in the area of voluntary cooperation, considering their impact on patients, public health or healthcare systems.

3. In the preparation or amendment of the annual work programme, the Coordination Group shall:

(a) take into account the reports on emerging health technologies referred to in Article 22;

(b) take into account the information from the European Medicines Agency that is provided by the Commission pursuant to Article 28 on the status of submitted and upcoming marketing authorisation applications for medicinal products referred to in Article 7; as new regulatory data becomes available, the Commission shall share such information with the Coordination Group so that the annual work programme can be amended;

(c) take into account information provided by the Medical Device Coordination Group established in Article 103 of Regulation (EU) 2017/745 (‘Medical Device Coordination Group’) or other sources, and provided by the Commission pursuant to Article 28 of this Regulation on the work of the relevant expert panels referred to in Article 106(1) of Regulation (EU) 2017/745 (‘expert panels’);

(d) consult the stakeholder network referred to in Article 29, and take into account its comments;

(e) take into account the resources available to the Coordination Group for the joint work;

(f) consult the Commission on the draft annual work programme and take its opinion into account.

4. The Coordination Group shall adopt each year, at the latest by 28 February, its annual report.

5. The annual report shall provide information on the joint work carried out in the calendar year preceding its adoption.