ElViS – Electronic Vigilance System

Electronic Vigilance Reporting Portal

Pharmaceutical companies and healthcare professionals (HCP) can report suspected adverse drug reactions directly via the Internet.

Small and medium-sized pharmaceutical companies that do not have their own access to the Swissmedic pharmacovigilance database via the Gateway, as well as healthcare professionals who have been using paper forms to report such suspected cases, can now submit their reports to Swissmedic electronically.

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.

Registration for MAHs

1. The MAH registers for ElViS on the Swissmedic website:

2. The Informatics Service Center of Swissmedic (ISCS) creates a contract

3. The MAH signs the contract and delegates a Partner-Administrator

4. ISCS creates the Partner-Administrator Account

Registration for HCPs

The registration for HCPs is described step by step in the document below:


ElViS Hotline

+41 58 462 06 00

Mon-Fri von 07:30 - 17:30

FAQ - ElViS

General

Registration

Entering a new report

Submitting follow-up reports

Receiving messages and answering queries