Swissmedic

Updating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway

Guidance updated to reflect completed transition from E2B(R2) to E2B(R3) reporting and GVP Module VI Addendum II requirements.

Medium impact Pharmaceuticals Switzerland pharmacovigilance

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.

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