Article 2

Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level · European Union

For the purposes of this Regulation, the following definitions apply: ‘monitoring’ means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371 ; ‘public health emergency’ means a public health emergency at Union level recognised by the Commission in accordance with Article 23 of Regulation (EU) 2022/2371; ‘medical countermeasures’ means medical countermeasures within the meaning of Article 3, point (10), of Regulation (EU) 2022/2371, including personal protective equipment and substances of human origin; ‘raw materials’ means the materials required in order to produce the required quantities of crisis-relevant medical countermeasures; ‘real-world data’ means data relating to patient health status or the delivery of healthcare from sources other than clinical trials.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.