Reporting/submitting suspected adverse drug reactions by pharmaceutical companies

Marketing Authorisation Holders (MAH) basically have two options for submitting suspected adverse drug reactions to Swissmedic:

  1. Electronic reports via the ElViS portal (Electronic Vigilance System)
    Submitting reports via a web-based online tool
  2. Gateway for the electronic exchange of individual case safety reports
    The reports are transferred directly to Swissmedic's database.

Registration processes are required for both options. Please note that, as of 1 July 2021, Swissmedic will only accept electronic reports either via ElViS or a Gateway connection.

Last modification 02.06.2021

Top of page