Draft European Union individual case safety report (ICSR) implementation guide

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Document details

Download document Draft European Union individual case safety report (ICSR) implementation guide
Reference number EMA/51938/2013
Status draft: consultation open
First published 30/04/2014
Last updated 30/04/2014
Consultation start date 30/04/2014
Consultation end date 30/06/2014
Email address for submissions eu-ig-icsr@ema.europa.eu

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.