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Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) article 30 CELEX: 32021R2282 IT platform
1. The Commission shall set up and maintain an IT platform consisting of: (a) a publicly accessible webpage; (b) a secure intranet for the exchange of information between members of the Coordination Group and its subgroups; (c) a secure system for the exchange of information between the Coordination Group and its subgroups with health technology developers and experts participating in the joint work referred to in this Regulation, as well as with the European Medicines Agency and the Medical Device Coordination Group; (d) a secure system for the exchange of information between members of the stakeholder network. 2. The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member States, members of the stakeholder network and the general public. |
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance) article 30 CELEX: 32021R2282 3. The publicly accessible webpage shall contain, in particular: (a) an up-to-date list of the members of the Coordination Group and their appointed representatives, together with their qualifications and areas of expertise and their declarations of conflict of interest after the finalisation of the joint work; (b) an up-to-date list of the members of the subgroups and their appointed representatives, together with their qualifications and areas of expertise and their declarations of conflict of interest after the finalisation of the joint work; (c) the rules of procedure of the Coordination Group; (d) all documentation under Article 9(1), Article 10(2) and (5) and Article 11(1) at the time the joint clinical assessment report is published, under Article 10(7) in the event that the joint clinical assessment was discontinued, and under Articles 15, 25 and 26; (e) the agendas and summary minutes of the Coordination Group’s meetings, including the decisions adopted and voting results; (f) the eligibility criteria for stakeholders; (g) the annual work programmes and annual reports; (h) information on planned, on-going, and completed joint clinical assessments, including updates carried out in accordance with Article 14; (i) the joint clinical assessment reports considered procedurally compliant in accordance with Article 12, together with all comments received during their preparation; (j) information on Member States’ national clinical assessment reports referred to in Article 13(2), including information provided by Member States on how joint clinical assessment reports were considered at national level, and Article 24; (k) anonymised, aggregated, non-confidential summary information on joint scientific consultations; (l) studies on the identification of emerging health technologies; (m) anonymised, aggregated, non-confidential information from the reports on emerging health technologies referred to in Article 22; (n) results of the voluntary cooperation between Member States undertaken pursuant to Article 23; (o) where a joint clinical assessment is discontinued, the statement pursuant to Article 10(6), including a list of the information, data, analyses or other evidence that were not submitted by the health technology developer; (p) the procedural review of the Commission according to Article 12(3); (q) standard operating procedures and guidance regarding quality assurance pursuant to Article 4(2) and (3); (r) the list of stakeholder organisations included in the stakeholder network, together with the declarations of those organisations on their membership and sources of funding, and the declarations of interests of their representatives, pursuant to Article 29(4). |