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