Europe – EU Individual Case Safety Report (ICSR)1 Implementation Guide

Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC and Regulation 536/214 outline the electronic reporting requirements to EudraVigilance (EV), the data processing network and management system for reporting and evaluating suspected adverse reactions during the development and following the marketing authorisation of medicinal products in the European Economic Area (EEA). 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 EEA…