4. EudraVigilance

1.1. EudraVigilance system: users and data sources

Figure 1 gives a high-level system overview of EudraVigilance. Further details are provided in the following sections.

Figure 1. EudraVigilance users, data sources and data use. (adapted from EMA 2019-annual-report-eudravigilance)
*[ICSR: a document providing information related to an individual case of a suspected adverse reaction due to a medicine]