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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 1 CELEX: 32021R2282 Subject matter
1. This Regulation establishes: (a) a support framework and procedures for cooperation of Member States on health technologies at Union level; (b) a mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level; (c) common rules and methodologies for the joint clinical assessment of health technologies. 2. This Regulation shall not affect Member States’ competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of a health technology in their specific national health context. It shall not interfere with the exclusive national competence of Member States, including those for national pricing and reimbursement decisions, or affect any other competences which concern Member States’ management and delivery of health services or medical care or the allocation of resources assigned to them. |