Reporting/submitting suspected adverse drug reactions by pharmaceutical companies
Marketing Authorisation Holders (MAH) basically have two options for submitting suspected adverse drug reactions to Swissmedic:
- Electronic reports via the ElViS portal (Electronic Vigilance System)
Submitting reports via a web-based online tool
- Gateway for the electronic exchange of individual case safety reports
The reports are transferred directly to Swissmedic's database.
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).
ElViS 2.0
The Electronic Vigilance System (ElViS) is being replaced by an updated reporting tool in E2B(R3) format
Electronic reports via the ElViS portal
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 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
Related documents
FAQ
Why should I use ElViS to report adverse reactions?
Electronic reporting offers a large number of advantages. Your data are recorded in a structured fashion and checked to ensure they are complete and plausible before they are submitted. Furthermore, you can attach important documents such as laboratory reports, hospital letters, etc. to your report. Your report is imported directly into Swissmedic's drug safety database, where it can be processed immediately by the National Pharmacovigilance Centre. This means that risks are identified earlier and more accurately. Further advantages include data security and the fact that all documents are electronically archived.
Why can I only store one unfinalised report in ElViS?
ElViS is primarily a reporting platform, not a database. That's why submitted reports are only stored in ElViS for a limited period of time. However, you can resume work on any unfinalised report that you store in ElViS whenever you want.
How long will reports that I submit be stored in ElViS?
No more than 6 weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer.
Are my data really secure?
Recommended browsers
For the ELVIS application we recommend the following browsers: Microsoft Edge und Mozilla Firefox
Whom do I contact if I have questions or problems?
Excerpt from the official page. The original is authoritative. Continue reading at Swissmedic ↗