Quote from VigiServe Admin on March 12, 2021, 2:14 PM

The Marketing Authorisation Holders (MAH) have two options for submitting suspected adverse drug reactions to the Swissmedic:

Electronic reports via the ElViS portal (Electronic Vigilance System)
Submitting reports via a web-based online tool

Submission via ElViS is intended for use by small to medium-sized pharmaceutical companies without their own access (via Gateway) to Swissmedic's pharmacovigilance database.

Registration process for the MAHs

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

Registration Swissmedic Portal

2. The Informatics Service Center of Swissmedic (ISCS) creates a contract3. The MAH signs the contract and delegates a Partner-Administrator

4. ISCS creates the Partner-Administrator Account

Gateway for the electronic exchange of individual case safety reports
The reports are transferred directly to Swissmedic's database.

Companies interested in the Gateway solution must fulfil the following requirements:

• The company undertakes to pay the external activation costs of CHF 10,000. There are no plans for an annual subscription;
• The company undertakes to make the resources needed to integrate the Gateway solution available within about three months. This includes designating a coordinator;
• The company is able to exchange ICSR electronically using the AS2 or AS1 protocols.

Companies that are interested in using the Gateway solution and that fulfil the above requirements should send a letter of intent to pvgateway@swissmedic.ch. After examining the letter, Swissmedic will contact the company to its involvement in detail.