Contents
Article 9Assessment scope proposal#
1.The assessor, with the assistance of the co-assessor, shall prepare an assessment scope proposal with a set of the parameters for the joint clinical assessment in terms of patient population, intervention, comparators and health outcomes, taking into account the information provided by the health technology developer under Article 2. At any time during the preparation of the assessment scope proposal, the assessor and/or co-assessor may seek, via the HTA secretariat, input on the assessment scope from the patients, clinical experts and/or other relevant experts selected in accordance with Article 6. The HTA secretariat shall make this input available to the entire JCA Subgroup.
2.The HTA secretariat shall share the assessment scope proposal with the members of the JCA Subgroup. Based on the input received from the Member States, the assessor, with the assistance of the co-assessor, shall prepare a consolidated assessment scope proposal reflecting the Member States’ needs.
3.The HTA secretariat shall share the consolidated assessment scope proposal with the patients, clinical experts and other relevant experts selected in accordance with Article 6 and give them the opportunity to provide input.
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