|Download document||Draft European Union individual case safety report (ICSR) implementation guide|
|Status||draft: consultation open|
|Consultation start date||30/04/2014|
|Consultation end date||30/06/2014|
|Email address for firstname.lastname@example.org|
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.