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National clinical assessment reports
Where an HTA, or its update, is carried out by a Member State on a health technology referred to in Article 7(1), that Member State, through its designated member in the Coordination Group, shall provide the national assessment report on that health technology to the Coordination Group through the IT platform referred to in Article 30 within 30 days after its completion.
General procedural rules
1. The Commission shall adopt, after consulting all relevant stakeholders, by means of implementing acts, general procedural rules: (a) ensuring that the members of the Coordination Group, its subgroups, as well as patients, clinical experts and other relevant experts take part in joint clinical assessments in an independent and transparent manner, free from conflict of interest; (b) on the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts in joint clinical assessments at Union level. 2. Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Format and templates of submission and report documents
1. The Commission shall adopt, by means of implementing acts, the format and templates in respect of: (a) dossiers for information, data, analyses and other evidence to be provided by health technology developers for joint clinical assessments; (b) joint clinical assessment reports; (c) summary joint clinical assessment reports. 2. Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
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