Following an increase in the number of reports of adverse drug reactions (ADR) received from the pharmaceutical industry, Swissmedic will be prioritising ADR reports submitted electronically, particularly those from authorisation holders.
Swiss Medic will give a priority to the review of ADRs submitted via two electronic systems: the E2B Gateway and ELViS (Electronic Vigilance System). The E2B Gateway is used by companies that generally large volumes (>70 ADRs per year) a year, whilst ELViS is intended for small and medium-sized companies.
While hard copy reports are still accepted at present, Swiss Medic are currently determining the date from which reports, particularly those from companies will have to be submitted exclusively electronically.
Please click here to read the announcement from Swiss Medic.