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Swissmedic: Reporting/submitting suspected adverse drug reactions by pharmaceutical companies

1 September 2026

Swissmedic: Reporting/submitting suspected adverse drug reactions by pharmaceutical companies

Swissmedic has recalled the arrangements under which marketing authorisation holders (MAHs) submit suspected adverse drug reactions. MAHs have two options: electronic reports via the web-based ElViS portal (Electronic Vigilance System), or a gateway for the electronic exchange of individual case safety reports, whereby reports are transferred directly to Swissmedic's database. Both options require registration process.

Since 1 July 2021, Swissmedic has accepted electronic reports only via ElViS or a gateway connection. Unlike the gateway, ElViS supports the exchange of reports only in the E2B(R2) format, whereas MAHs exchanging reports via the gateway havebeen gradually migrated from the former E2B(R2) format to the new E2B(R3) format since the third quarter of 2024.

For more information, see here.

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