Definitions
Article 2
For the purposes of this Regulation, the following definitions apply: (1) ‘monitoring’ means monitoring as defined in Article 3, point (6), of Regulation (EU) 2022/2371 ; (2) ‘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; (3) ‘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; (4) ‘raw materials’ means the materials required in order to produce the required quantities of crisis-relevant medical countermeasures; (5) ‘real-world data’ means data relating to patient health status or the delivery of healthcare from sources other than clinical trials.