ELViS: Swissmedic's Reporting Portal
Short answer
ELViS is Swissmedic's Electronic Vigilance System. Healthcare professionals and marketing authorisation holders use it to report adverse drug reactions and quality defects. Serious cases must be reported within 15 days, with marketing authorisation holders submitting structured data sets.
Who must report, and what?
Healthcare professionals report suspected serious adverse reactions, previously unknown reactions and quality defects. Marketing authorisation holders are subject to a broader reporting obligation with fixed deadlines and periodic safety update reports. Patients can also report.
| Reporting party | Subject of the report | Deadline |
|---|---|---|
| Healthcare professional | Suspected serious adverse reaction | within 15 days |
| Healthcare professional | Previously unknown reaction or quality defect | within 15 days |
| Marketing authorisation holder | Serious case from Switzerland | within 15 days |
| Marketing authorisation holder | Non-serious cases | periodically as required |
| Marketing authorisation holder | Safety-related measure abroad | without delay |
| Marketing authorisation holder | Periodic safety update report | on the set cycle |
| Patient | Own observation | voluntary |
How do I report in ELViS?
You register once for access, create a report, and enter pseudonymised patient data, the suspected medicinal product, the course of events, concomitant medication, and your assessment of the causal link. After submitting, you receive a reference number for follow-up reports.
- Request access and choose the role that matches your function.
- Create the report and enter the case in pseudonymised form, with no identifying details.
- State the suspected medicinal product with authorisation number and batch, if known.
- Document the course, measures taken, outcome and concomitant medication.
- State your own assessment of the causal link.
- Submit and keep the reference number; base follow-up reports on it.
What makes a good report?
An assessable report states the timeline, dose, course after stopping, comorbidities and concomitant medication. Without the timeline, the causal link cannot be assessed. A few complete reports are more valuable for signal detection than many incomplete ones.
- Temporal relationship: start of therapy, onset of the event, stopping, subsequent course.
- Dose, dosage form, batch number where available.
- Concomitant medication and relevant pre-existing conditions.
- Outcome: recovered, ongoing, permanent harm, fatal.
- Assessment of the causal link with brief reasoning.
What additional duties do marketing authorisation holders have?
They need a pharmacovigilance system, a responsible person domiciled in Switzerland, a pharmacovigilance system master file, defined processes for case handling and signal management, and the ability to submit reports in structured form.
Frequently asked questions
Is reporting mandatory for healthcare professionals?
Yes, for suspected serious and previously unknown adverse reactions and for quality defects. The obligation follows from the Therapeutic Products Act and the Therapeutic Products Ordinance.
Can I report as a patient myself?
Yes, voluntarily. A report through the treating healthcare professional generally provides more medical detail and is therefore easier to assess.
Is patient data transmitted?
Only in pseudonymised form. No details permitting direct identification may be entered.
What is the difference from reporting a medical device incident?
Medical devices are covered by materiovigilance, with its own forms and deadlines under the MedDO. Medicinal product reports go through ELViS.
How quickly does Swissmedic react?
Individual reports do not automatically trigger a measure. They feed into signal detection; once a signal is confirmed, measures follow, such as information letters, text changes or restrictions.
Sources
- Swissmedic: Vigilance and Reporting
- Fedlex SR 812.212.21 TPO, pharmacovigilance
- Swiss Pharmacovigilance (partner site)
Last updated: