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1. 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]