EMEA: Note for guidance Eudravigilance Human - Processing of safety messages and individual case safety reports (ICSRs)

The purpose of this guidance is to describe the aspects of the message processing and acknowledgment generation implemented in EudraVigilance (EV). It updates and replaces the business rules and validation steps as described in the ‘Note for Guidance – EudraVigilance Human Version 7.0 – Processing of Safety Messages and Individual Case Safety Reports (ICSRs)’ (Doc. Ref. EMEA/H/20665/04/Final).