EudraVigilance system overview

EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.

The system contains different components that perform specific tasks in the process of electronic reporting of suspected adverse drug reactions.

This illustration shows how the system components are connected (click to enlarge):

EudraVigilance system components


Click on the links below for explanations of each system component:

Data submission and collection

Data management

Data analysis

Reference sources and services

Security management


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