Article 19: Identification of changed risks and new risks

1.   The identification of new risks or changed risks shall be based on the detection and analysis of the signals concerning a medicinal product or an active substance.

For the purposes of this chapter, ‘signal’ means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, which is judged to be of sufficient likelihood to justify verificatory action.

For the purpose of monitoring data in the Eudravigilance database, only signals related to an adverse reaction shall be considered.

2.   The detection of a signal shall be based on a multidisciplinary approach. Signal detection within the Eudravigilance database shall be complemented by statistical analysis, where appropriate. After consultation with the Pharmacovigilance Risk Assessment Committee, the Agency may publish a list of medical events that have to be taken into account for the detection of a signal.