Marketing Authorisation Holders (MAH) basically have two options for submitting suspected adverse drug reactions to Swissmedic: Registration processes are required for both options. Please note that, since 1 July 2021, Swissmedic will only accept electronic reports either via ElViS or a Gateway connection. Unlike the gateway, the exchange of reports via ElViS is only possible in E2B(R2) format. Since the third quarter of 2024, MAH who exchange reports with Swissmedic via the gateway have been gradually switched from the old format E2B(R2) to the new format E2B(R3).
Swissmedic
Requirements of the Responsible Person for Pharmacovigilance
Original title: MU100_00_001e_WL_Requirements of the Responsible Person for Pharmacovigilance
Swissmedic requires electronic adverse drug reaction reporting via ElViS (E2B(R2)) or gateway (transitioning from E2B(R2) to E2B(R3) from Q3 2024).
Applies from
2021-07-01
Published by Swissmedic. HealthSignal links to the original document; the summary above is extracted from the source text.