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 30/04/2014
Last updated 21/01/2015

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.