ElViS (Electronic Vigilance System)

Electronic Vigilance Reporting Portal

Since the start of October 2014, healthcare professionals and pharmaceutical companies have been able to report suspected adverse drug reactions directly via the Internet.

This means that small and medium-sized pharmaceutical companies that do not have their own access to the Swissmedic pharmacovigilance database via the Gateway can now submit their reports to Swissmedic electronically. There is only one condition to be fulfilled: registration on the portal website and, for companies, attendance at a Swissmedic training course. Similarly, healthcare professionals who have hitherto been using report forms to notify the regional pharmacovigilance centres of suspected ADR can now prepare and send their reports online.
ElViS can also be used to send case-related documents such as laboratory or hospital discharge reports. Once their report has been sent, users can save it and the acknowledgement of receipt on their computer’s hard drive for their own records. Data protection and security satisfy the most stringent requirements.

This modern, user-friendly reporting portal makes it easier for healthcare professionals and the industry to fulfil their statutory reporting obligations. Swissmedic hopes that this solution will result in faster submission of better-quality reports, thereby improving drug and patient safety in Switzerland.

https://www.swissmedic.ch/content/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance/elvis--electronic-vigilance-system-.html