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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  4

CELEX:  32021R2282

Quality assurance
1. The Coordination Group shall ensure that the joint work carried out pursuant to Articles 7 to 23 is of the highest quality, follows international standards of evidence-based medicine, and is delivered in a timely manner. For that purpose, the Coordination Group shall establish procedures that are systematically reviewed. When developing such procedures, the Coordination Group shall consider the specificities of the health technology to which the joint work relates, including orphan medicinal products, vaccines and advanced therapy medicinal products.
2. The Coordination Group shall establish and regularly review standard operating procedures falling within the scope of Article 3(7), points (d), (e), (f) and (g).
3. The Coordination Group shall regularly review, and where necessary update, methodological and procedural guidance falling within the scope of Article 3(7), points (d), (e), (f) and (g).
4. Where appropriate, and taking into account the methodology already developed by the EUnetHTA Joint Actions, specific methodological and procedural guidance shall be developed for medicinal products, medical devices and in vitro diagnostic medical devices.