Clarification of definitions in the area of the electronic interchange of reports

EudraVigilance – a database and a system for electronic interchange of reports within the EEA, established and managed by EMA

Individual Case Safety Report (ICSR) – a report of suspected adverse drug reaction

Acknowledgement (ACK) – an ichicsrack report in the xml format – a report sent by the recipient of ICSR to the sender, confirming successful processing of the sent report (code AA – CA) or informing about errors preventing the processing of this report (code AE – CR or AR) Follow-up of the report – a complement of the new important additional information to the initially reported ADR report

MAH – a marketing authorisation holder of a medicinal product

Re-routing of ICSRs – an automatic process done by EMA during which ICSRs sent to EV database by MAHs are re-routed (re-sent) to particular NCAs in the EEA down by the country of a (main) reporter.