BILLEV PHARMA EAST

NEWS

14 March 2024

EudraVigilance – EVWEB User Manual UPDATE

EudraVigilance is the European data-processing network and database management system for the exchange, processing and evaluation of IndividualCaseSafetyReports (ICSRs) related to medicinal products authorised in the European Economic Area (EEA).

 

EVWEB User Manual is part of the official documentation prepared by the European Medicines Agency to support the use of the EudraVigilance Web reporting tool (EVWEB).

 

The User Manual has been updated to version 1.7 (29 February 2024 ).

 

  • Revision 1.7 contains the following updates:
  • Figures 5 and 126 were amended.
  • Some hyperlinks were updated (in sections 1-4);
  • References to the ICH E2B(R2) message format were updated (or removed where applicable, as this message format was superseded by the ICH E2B(R3) format);
  • The following section was updated: 3.9.1 “Import Function”;
  • The following sections were added: 3.9.1.1 “Import of a single XML file”, 3.9.1.2 “Import of multiple XML files” and 3.11.3.2 “Use of Automation tools (API/RPA) in the ICSR download and Captcha control for Level 2B (L2B) download requests”;
  • Some editorial amendments were made to align the format with other EMA documents.

 

Link to download the new EVWEB User Manual: eudravigilance-evweb-user-manual_en.pdf (europa.eu)