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1. Following the acceptance of a request for a joint scientific consultation in accordance with Article 17, the Coordination Group shall initiate the joint scientific consultation by designating a subgroup for the joint scientific consultation. The joint scientific consultation shall be carried out in accordance with the requirements and procedures established pursuant to Article 3(7), point (f), and Articles 20 and 21.

2. The health technology developer shall submit up-to-date documentation containing the information necessary for the joint scientific consultation, in accordance with the requirements set out pursuant to Article 21, point (b), in the timeframe set out pursuant to Article 3(7), point (f).

3. The designated subgroup shall appoint from among its members an assessor and a co-assessor from different Member States to conduct the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the consultation.

4. The assessor, with the assistance of the co-assessor, shall prepare the draft joint scientific consultation outcome document in accordance with the requirements set out in this Article and in accordance with the guidance documents and procedural rules established pursuant to Article 3(7), points (d) and (f), and Article 20. For medicinal products, in accordance with international standards of evidence-based medicine, directly comparative clinical studies which are randomised, blinded and include a control group shall be advised whenever appropriate.

5. The members of the designated subgroup shall have the opportunity to provide their comments during the preparation of the draft joint scientific consultation outcome document. Members of the designated subgroup may, as appropriate, provide additional recommendations specific to their individual Member State.

6. The designated subgroup shall ensure that patients, clinical experts and other relevant experts are given an opportunity to provide input during the preparation of the draft joint scientific consultation outcome document.

7. The designated subgroup shall organise a face-to-face or virtual meeting for an exchange of views with the health technology developer and patients, clinical experts and other relevant experts.

8. Where the joint scientific consultation is carried out in parallel with the preparation of a scientific advice given by the European Medicines Agency or the consultation of an expert panel, representatives of the European Medicines Agency or of the expert panel, respectively, shall be invited to participate in the meeting, to facilitate coordination as appropriate.

9. Following receipt and consideration of any comments and input provided in accordance with this Article, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation outcome document.

10. The assessor, with the assistance of the co-assessor, shall take into account comments received during the preparation of the joint scientific consultation outcome document and submit its final draft, including any recommendations specific to individual Member States, to the Coordination Group.