Swissmedic

ElViS 2.0: Electronic Vigilance System replacement

Original title: ElViS 2.0

Swissmedic is replacing the ElViS adverse drug reaction reporting tool with ElViS 2.0 to support E2B(R3) format exchange, launching 21 December 2026.

Low obligation Framework Pharmaceuticals Health Data, Privacy & Security Switzerland PharmacovigilanceHealth dataInteroperability

The Electronic Vigilance System (ElViS) is a reporting tool for suspected adverse drug reactions (ADRs). It was introduced in 2014 and there are two versions: healthcare professionals can report ADRs via ElViS HCP while pharmaceutical companies and marketing authorisation holders who do not exchange reports with Swissmedic via the Gateway use ElViS MAH. For technical reasons, and to be able to exchange reports in the new international E2B(R3) format, the current tool is being replaced by the updated ElViS 2.0. Launch is planned on 21 December 2026. Please note the following: ElViS 2.0 for healthcare professionals

Dates and deadlines

Applies from

2026-12-21

Regulatory Deadline

December 21, 2026

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