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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 26 CELEX: 32021R2282 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). |