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.

Exception: Authorisation holders (MAH) domiciled outside of Switzerland

Exceptions to the aforementioned rule apply only to companies that do not have a Swiss place of domicile, with which a contractual agreement for the electronic transmission of reports via ElVis or Gateway is not possible. For these exceptions only, please submit your reports using

  • a CIOMS sheet
  • and the backing form given below.
 

Related documents

Last modification 31.08.2021

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