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Swissmedic: ElViS 2.0 – Updated reporting tool for adverse drug reactions in E2B(R3) format

4 September 2026

Swissmedic: ElViS 2.0 – Updated reporting tool for adverse drug reactions in E2B(R3) format

Swissmedic has announced that the Electronic Vigilance System (ElViS), the reporting tool for suspected adverse drug reactions introduced in 2014, is being replaced by an updated version, ElViS 2.0, for technical reasons and to enable the exchange of reports in the new international E2B(R3) format. Launch is planned for 21 December 2026. For healthcare professionals, changes will be minor, with continued login via AGOV or HIN, a single-page input form with a navigation sidebar, and a new messaging function for direct queries to Swissmedic. For marketing authorisation holders, the new tool enables the exchange of individual case reports in E2B(R3) format, with data entered manually or uploaded as E2B files, including validation of older E2B R2.1 files to meet the R3 standard. Swissmedic will hold an online training session for marketing authorisation holders in early December 2026.

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