ElViS: the Swissmedic vigilance reporting portal
ElViS is the Swissmedic electronic vigilance reporting portal. Since 1 July 2021 Swissmedic accepts reports from marketing authorisation holders electronically only, through a gateway connection in E2B format or through the ElViS portal. Healthcare professionals may use it as well.
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What is ElViS?
ElViS stands for electronic vigilance system. It is the Swissmedic intake interface for medicinal product vigilance reports, with roles for companies, healthcare professionals and institutions. Access runs through the federal login eIAM.
Portal or gateway: which suits you?
The portal is a web interface where a case is entered by hand or an E2B file uploaded. The gateway is a machine interface that connects your safety system directly to Swissmedic. From roughly fifty to a hundred cases a year the gateway pays for itself; below that the portal is more robust because there is no interface to maintain.
| Criterion | ElViS portal | Gateway |
|---|---|---|
| Suits | Low to medium case volume | High volume, group safety systems |
| Entry | Manual or E2B upload | Automated from the safety system |
| Set-up | eIAM account and a role request | Technical registration and a test phase |
| Format | Form or E2B(R3) | E2B(R3) |
| Acknowledgement | Visible in the portal | Acknowledgement message |
| Effort per case | Higher | Low once set up |
Setting up access
Access takes two steps: a personal eIAM account and the activation of the company role for ElViS. Allow lead time for that, and set up at least two people from the start, otherwise your ability to report rests on a single person's holiday.
- Create an eIAM account and secure it with two factor authentication.
- Request access to ElViS and have the role assigned to your company.
- Set up at least one deputy with identical rights.
- For gateway use, complete the technical registration and the test submission with Swissmedic.
- Document the access, the roles and the responsibilities in your PV SOP.
Entering a report in the portal
The portal follows the E2B data model: administrative data and source first, then patient, then product, then reaction, then course and outcome. If you prepare the fields in that order you fill in the form without jumping back.
- Administrative: report type, source, date of first awareness as day 0
- Patient: initials, year of birth, sex, weight where relevant
- Product: name, Swiss authorisation number, dose, route, batch for biologicals
- Reaction: MedDRA term, onset, end, seriousness, expectedness
- Course: action taken, re-exposure, outcome, concomitant medication
Mistakes that make a report useless
The date of first awareness is set to the day of data entry, which moves the deadline. The reaction is typed as free text instead of a MedDRA term. The product is entered without the Swiss authorisation number, so it cannot be identified. The acknowledgement is not filed, so the submission cannot later be evidenced.
Acknowledgement and evidence
Every submission produces an acknowledgement, as an entry in the portal or as an acknowledgement message over the gateway. File it in the case record. It is the only proof that the report reached Swissmedic inside the deadline, and it is the first document an inspection asks for.
Outage and the fallback route
If the portal or your gateway goes down, the deadline keeps running. Document the outage with a timestamp and a screenshot, contact Swissmedic and submit immediately once service returns. A described fallback route in the SOP exists for exactly this case and is asked about in inspections.
Frequently asked questions
Is ElViS mandatory for healthcare professionals?
No. The electronic reporting duty through ElViS applies to marketing authorisation holders. Healthcare professionals may use ElViS or report through a regional pharmacovigilance centre.
Which E2B version does Swissmedic require?
Swissmedic works with ICH E2B(R3) and MedDRA coded terms. Before building a gateway connection, check the current technical specification and the manual on the ElViS page, because versions and validation rules are updated.
Can we use ElViS through a service provider?
Yes. A service provider may submit, but the responsibility stays with the authorisation holder. Set scope, deadlines and escalation out in an SDEA and have the submission acknowledgements forwarded to you systematically.
What does ElViS cost?
Using the reporting portal itself is not charged. The effort sits in the gateway connection, in validation and in operating your safety system.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.