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
There will only be minor changes for healthcare professionals. Login is via AGOV and will also continue to be possible using HIN. The full input form is now visible on a single page and a sidebar facilitates navigation through the largely unchanged input fields. Uploading case-related documents directly in the application remains possible in order to keep the manual entries needed to a minimum. A new message function will also enable direct questions to Swissmedic regarding a report.
ElViS 2.0 for marketing authorisation holders
The new reporting tool for marketing authorisation holders enables the exchange of individual case reports in E2B(R3) format. Users have the option of either entering all the data manually in an updated interface or uploading E2B files. If a file is uploaded in the older E2B R2.1 format, the application allows manual amendment completion and validation, so that the report sent to Swissmedic meets the R3 standard.
Swissmedic in turn sends reports to marketing authorisation holders in R3 format. ElViS 2.0 provides these as a file in various formats (E2B(R3), E2B R2.1 and PDF). This ensures that, if the marketing authorisation holder downloads the report in an older format, all data remains available and can be amended locally.
Swissmedic will update the relevant information and documentation on the website before ElViS 2.0 is launched and will provide information on the current status as necessary. An online training session for marketing authorisation holders on sending ADR reports via ElViS 2.0 is planned in early December.