Reporting cases as a marketing authorisation holder
Authorisation holders submit individual cases electronically only, through a gateway connection in E2B format or through the ElViS portal. Serious cases within 15 days and non-serious, previously unknown ones within 60 days, each counted from a day 0 you can defend with a source document.
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- Reviewed by Swiss Pharmacovigilance
What is an ICSR?
An ICSR, an individual case safety report, is the structured report of a single suspected case. The data standard is ICH E2B(R3), an XML format with MedDRA coded terms. Swissmedic accepts ICSRs through the gateway or the ElViS portal, not by e-mail and not on paper.
Setting day 0 correctly
Day 0 is the calendar day on which the minimum information first reaches anywhere in your organisation or a contracted third party. That includes the field force, the medical information inbox, the distributor's complaint hotline and any partner under an SDEA. It is not the day your PV department receives the case.
The most common inspection finding
A case reaches the PV department through the field force four days late, the deadline is counted from arrival in the department and is formally met. Substantively it has been missed. Record the first contact in the case log and train every patient-facing function on the 24 hour forwarding rule.
The case process from intake to submission
The process looks the same in every organisation and an inspection asks about it in exactly this order. What matters are the handovers: who decides on seriousness, who on expectedness, and where those decisions are documented.
- Intake and triage: source, date, completeness of the minimum information, duplicate check.
- Assessment: serious or not, expected or unexpected against the Swiss product information, causality.
- Coding: reaction and history in MedDRA, product against the Swiss authorisation number.
- Follow-up: a targeted question within days, with at least two documented attempts.
- Medical review and release by the RPPV or a named delegate.
- Submission through ElViS and filing of the acknowledgement in the case file.
Expectedness against the Swiss product information
Expectedness is always assessed against the product information approved in Switzerland, not against the EU SmPC and not against the company core safety information. This is where EU-built processes fail in Switzerland: a reaction can be listed in the EU and unexpected in Switzerland, which changes both the reportability and the deadline.
| Case | Deadline | Format | Channel |
|---|---|---|---|
| Serious, Switzerland | 15 days | E2B(R3) | Gateway or ElViS portal |
| Non-serious and unexpected, Switzerland | 60 days | E2B(R3) | Gateway or ElViS portal |
| Follow-up with new relevant information | As the initial report | E2B(R3) | Gateway or ElViS portal |
| Quality defect with a health risk | Without delay | Form | Market surveillance |
| Safety-related action taken abroad | Without delay | Letter | Swissmedic |
Foreign cases and literature cases
What has to reach Swissmedic are cases from Switzerland. Foreign cases are not submitted individually, but they feed the PSUR and signal management. The exception is safety-related action taken abroad, such as a recall, an indication restriction or a market withdrawal: that has to be reported to Swissmedic without delay, because it bears directly on the Swiss benefit-risk balance.
Literature cases with an identifiable patient in Switzerland are treated like spontaneous cases, with day 0 on the day you became aware of the publication. The documented search strategy behind that is part of your PV system.
What Swissmedic checks in an inspection
The review follows a case from intake to submission and compares what the SOP describes with what the case log shows. Expect sampling across twelve to twenty-four months and the question of how you found your own deadline breaches.
- Day 0 against the source document, not against the database field
- Deadline compliance and the list of breaches with root cause analysis
- Expectedness assessed against the current Swiss product information
- Completeness and quality of the follow-up attempts
- Training records for every patient-facing function
- SDEAs with partners, including the deadline cascade and the escalation path
Frequently asked questions
Can we still send cases to Swissmedic by e-mail?
No. Since 1 July 2021 Swissmedic accepts only electronic reports from marketing authorisation holders, either through a gateway connection in E2B format or through the ElViS portal. E-mail and paper are no longer acceptable from companies.
Do we have to submit foreign individual cases to Swissmedic?
Individual foreign cases are not individually submittable. They feed the PSUR and signal management. Safety-related action taken abroad, by contrast, has to be reported without delay.
How do we document follow-up attempts defensibly?
Record every attempt with date, channel and result, together with the specific question asked. Two documented, substantively targeted attempts are generally regarded as adequate; for serious cases with a missing outcome Swissmedic expects more.
Who may release a case?
Release sits with the qualified person responsible for pharmacovigilance, or with a person named in the SOP who holds the necessary medical qualification. The delegation has to be documented and the deputy arrangement written down.
What happens if we miss a deadline?
Detect it, document it, analyse the cause and correct it. A breach you found, analysed and corrected reads in an inspection as a controlled process. One the inspector finds and that is recorded nowhere is a system finding.
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.