European Union individual case safety report (ICSR) implementation guide

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Document details

Download document European Union individual case safety report (ICSR) implementation guide
Reference number EMA/51938/2013
Status adopted
First published 2014-04-30
Last updated 2015-01-21

Summary

This guidance specifies the technical requirements and the process of transmission of individual case safety reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the European Economic Area.