Pharmacovigilance and RPPV for Switzerland
A Responsible Person for Pharmacovigilance reachable in Switzerland, adverse reaction reporting through Swissmedic's ElViS portal, signal handling and periodic safety reports. The service scope and any subcontracting must be agreed in writing.
What does Swiss law require from a holder on safety?
The holder must operate a pharmacovigilance system, name a responsible person for it who can be reached in Switzerland, collect and assess suspected adverse reactions, report them to Swissmedic within the legal deadlines and keep the product information current when new safety information appears. The duty follows from Art. 59 HMG and the Medicinal Products Ordinance.
Practically that means someone in Switzerland has to answer a safety question on a working day, in a Swiss language, and be able to show an inspector how a report travelled from a pharmacist's phone call to a Swissmedic case. That is the function external providers provide.
RPPV
Public Swiss sources, independent explanations, and enquiries about external specialist services.
Which reporting deadlines apply in Switzerland?
Swiss deadlines are tight for serious cases and generous for the rest, and they are counted from the day the holder becomes aware of the case. External providers build the intake process so that day is documented, because an inspector will ask for it.
| Case type | Deadline | Route |
|---|---|---|
| Serious suspected adverse reaction in Switzerland | Within 15 days of awareness | ElViS case report |
| Non-serious suspected reaction in Switzerland | Within 60 days of awareness | ElViS case report |
| Safety signal requiring action | Without delay | Swissmedic contact plus label action |
| Periodic safety report | On the agreed cycle | Submission to Swissmedic |
| Quality defect with safety impact | Without delay | Joint PV and QA notification |
What the service contains
A complete Swiss safety function, sized for a company that does not have one. The interface to your global safety database is defined in a pharmacovigilance agreement so there is never a case that sits between two systems.
- Named RPPV towards Swissmedic, plus a deputy, both reachable in Switzerland.
- A Swiss intake channel for patients, pharmacists and physicians in German, French, Italian and English.
- Case processing, medical assessment and ElViS submission inside the deadlines.
- Exchange with your global safety database under a written pharmacovigilance agreement.
- Signal detection, literature screening and documented signal assessment.
- Periodic safety reports and the Swiss contribution to the pharmacovigilance system master file.
- Risk management measures in Switzerland, including educational material where required.
- Inspection support: the Swiss safety documentation is on site in Switzerland.
How the interface to your global system works
One rule keeps it clean: every case exists in both systems, and one party is the reporter to Swissmedic. Normally that is the providers, because the holder reports. Your global database stays the single scientific source, and the pharmacovigilance agreement fixes timelines, formats and reconciliation.
- Intake in Switzerland or notification from your side, with a documented awareness date.
- Assessment for seriousness, causality and expectedness against the Swiss product information.
- Reporting to Swissmedic via ElViS inside 15 or 60 days.
- Transfer of the case to your global database in the agreed format.
- Quarterly reconciliation so neither side carries a case the other does not know.
Why an in-house RPPV matters at inspection
The RPPV, quality function and regulatory team need documented reporting lines, escalation procedures and access to safety records. Confirm their respective responsibilities in the safety agreement.
Frequently asked questions
Can you be our RPPV without holding the authorisation?
Yes. Pharmacovigilance is a possible standalone mandate: companies with their own Swiss entity often lack a qualified safety person. The opposite does not work, because external providers do not hold authorisations whose safety system external providers cannot control.
In which languages do you take adverse reaction reports?
German, French, Italian and English. Swiss healthcare professionals report in their own language and expect an answer in it, so a single English mailbox is not an acceptable Swiss intake channel.
Do you need access to our safety database?
Not necessarily. External providers can work with structured case exchange in an agreed format, or with read access to your system if you prefer. Either way the pharmacovigilance agreement defines who reports to Swissmedic, in what time and how the two datasets are reconciled.
What about medical information enquiries?
Medical information is separate from pharmacovigilance but shares the intake channel. External providers answer product enquiries from healthcare professionals in three languages using approved material, and route anything that is actually a safety report into the PV process.
Enquire about Swiss MAH support
Describe your product, dossier status and support needs. Enquiries reach the website operator at info@mahswitzerland.com. Provider qualifications, availability and contracts must be checked separately.
- Independent information portal
- Public Swiss sources, independent explanations, and enquiries about external specialist services.