The changes take account of the completed changeover of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of GVP Module VI Addendum II.
Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway
The information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway has been updated. Specifically, the revision takes account of the completed changeover of the reporting process via the gateway from E2B(R2) to E2B(R3) and the requirements of GVP Module VI Addendum II.
Version 2.0 includes the following changes:
- Updating of the requirements and processes for the electronic transmission of Individual Case Safety Reports (ICSRs) on completion of the transition to E2B(R3) on the gateway
- Addition and clarification of the requirements for electronic reporting, including those concerning reporting obligations, patient identifiers, literature references and attachments
- Inclusion of requirements on the use of nullFlavor flags as specified in GVP Module VI Addendum II
- Clarification of organisational requirements connected with electronic reporting if several marketing authorisation holders report from one PV database (use of a common sender ID)
Other editorial changes and clarifications of content have also been made in all sections.
The updated information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway comes into force on 1 August 2026.
Excerpt from the official page. The original is authoritative.