Swiss pharmacovigilance for pharmaceutical companies
Planning a Swiss launch or reviewing your local safety setup? Understand RPPV responsibilities, reporting and outsourced PV services, then discuss the support your business needs.
Discuss your Swiss project- Independent information portal
- Public sources
- Eight languages
- 15 daysserious cases
- Reporting routesOfficial points of contact
- RPPV in houseArt. 65 TPO
Provider PV services for authorisation holders
External providers take on single building blocks or the whole Swiss pharmacovigilance system, the qualified person included.
- Outsourced RPPVExternal providers provide the qualified person responsible for pharmacovigilance, resident and reachable in Switzerland.I need a PV partner
- 24/7 case managementIntake, MedDRA coding, assessment, follow-up and on-time submission through ElViS.I need a PV partner
- PSUR and PBRERWriting, review and submission of periodic safety reports to ICH E2C(R2).I need a PV partner
The Swiss reporting deadlines at a glance
Swissmedic sorts by seriousness, not by reporter: fifteen days for a serious suspected case, sixty days for a non-serious and previously unknown one. For medical devices the Swiss MedDO adopts the EU MDR deadlines.
Day 0: when the clock startsThe clock starts on the day the minimum information first reaches any point in your company or a service provider. That day 0 is routinely the first thing an inspection checks.
| Case | Who reports | Deadline | Channel | Legal basis |
|---|---|---|---|---|
| Serious adverse drug reaction | Healthcare professional, authorisation holder | 15 days | ElViS | Art. 59 TPA, Art. 61 ff. TPO |
| Non-serious, previously unknown reaction | Healthcare professional, authorisation holder | 60 days | ElViS | Art. 59 TPA, Art. 61 ff. TPO |
| Reaction reported by the person affected | Patient, relatives | No deadline | Online form for patients | Voluntary report |
| Quality defect with a health risk | Authorisation holder, professional | Without delay | Swissmedic market surveillance | Art. 59 TPA |
| Device: serious public health threat | Manufacturer, authorised representative | 2 days | Economic operator form | Art. 66 MedDO, Art. 87 EU MDR |
| Device: death or serious deterioration in health | Manufacturer, authorised representative | 10 days | Economic operator form | Art. 66 MedDO, Art. 87 EU MDR |
| Device: other serious incidents | Manufacturer, authorised representative | 15 days | Economic operator form | Art. 66 MedDO, Art. 87 EU MDR |
| SUSAR in a clinical trial, fatal or life threatening | Sponsor | 7 days | Swissmedic and the ethics committee | ClinO |
| Other SUSARs in a clinical trial | Sponsor | 15 days | Swissmedic and the ethics committee | ClinO |
Provider PV services for authorisation holders
External providers take on single building blocks or the whole Swiss pharmacovigilance system, the qualified person included.
- Outsourced RPPVExternal providers provide the qualified person responsible for pharmacovigilance, resident and reachable in Switzerland.Read more
- 24/7 case managementIntake, MedDRA coding, assessment, follow-up and on-time submission through ElViS.Read more
- PSUR and PBRERWriting, review and submission of periodic safety reports to ICH E2C(R2).Read more
- Literature monitoringWeekly Embase and Medline searches, Swiss trade press, documented search strategy.Read more
- Risk management planAdapting the EU RMP to Switzerland, running the additional measures, checking effectiveness.Read more
- PV audits and trainingGap analysis, mock inspection, SDEA review and training in German, French and English.Read more
Your duties as a marketing authorisation holder
Eight building blocks Swissmedic checks in a pharmacovigilance inspection. Each one has its own guide.
Check your obligations- Name a reachable RPPVQualified person with demonstrable PV experience and a documented deputy.
- Run a pharmacovigilance systemA described system, SOPs, training records and a deviation and CAPA process.
- Report individual cases on timeFifteen and sixty days, electronically through ElViS, with a defensible day 0.
- Submit periodic reportsPSUR and PBRER on the interval Swissmedic sets for your authorisation.
- Document signal managementDetection, prioritisation, assessment and decision, minuted so an inspector can follow it.
- Monitor the literature systematicallyA documented search strategy, hit assessment and the reports that follow from it.
- Keep PV agreements currentSDEAs with partners, licensors and distributors, with a deadline cascade and escalation.
- Know the EU and Swiss differencesRPPV instead of QPPV, ElViS instead of EudraVigilance, and no automatic transfer of EU decisions.
What to check when choosing a PV provider
This independent information portal presents public sources and is not affiliated with public authorities.
Describe your regulatory support needs. This portal receives enquiries; an external provider’s services and qualifications must be agreed and verified separately.
Deadlines that hold
A documented day 0, daily deadline control and an on-call line that answers on a Friday evening too.
Four languages, one file
Reports and authority correspondence in German, French, Italian and English, with no translation loop.
Inspection experience
External providers run Swissmedic inspections from preparation through to closing the CAPAs, on documentation that holds up.
One point of contact
RPPV, case manager and regulatory lead sit at the same table. No ticket number, no callback tomorrow.
Explore the topics
The core topics of Swiss vigilance, each with deadlines, sources and a checklist.
Frequently asked questions
Who has to report adverse drug reactions in Switzerland?
The duty falls on healthcare professionals who prescribe, dispense or administer medicines, and on companies that manufacture or distribute ready-to-use medicinal products. The basis is Art. 59 of the Therapeutic Products Act. Patients may report but are not obliged to. Causality need not be proven: suspicion is enough.
What are the reporting deadlines?
Serious suspected cases must be reported within fifteen days, non-serious and previously unknown ones within sixty days. The clock starts on the day of first contact with the minimum information. Medical devices carry shorter deadlines: two days for a serious public health threat, ten days for a death.
What is ElViS?
ElViS is the Swissmedic electronic vigilance reporting portal. Since 1 July 2021 Swissmedic accepts reports from marketing authorisation holders electronically only, either through a gateway connection in E2B format or through the ElViS portal. Healthcare professionals may use it as well.
Does a foreign company need a Swiss RPPV?
Anyone holding a Swiss authorisation needs a working pharmacovigilance system and a qualified person responsible for pharmacovigilance. That person must be reachable during Swiss business hours, with on-call cover beyond them. Many foreign authorisation holders place the role with a Swiss service provider.
Is an EU QPPV enough for Switzerland?
No. Switzerland is not part of EudraVigilance and does not adopt EU decisions automatically. The EU QPPV may be the same individual in practice, but the Swiss role has to be named, documented and reachable separately, and reports have to reach Swissmedic.
What does outsourced Swiss pharmacovigilance cost?
The price follows the number of authorisations, the case volume and the scope: RPPV only, RPPV with case processing, or the full system including PSURs and literature monitoring. Send external providers your authorisation numbers and you get a price range within one working day.
Do you need an RPPV in Switzerland?
Describe the Swiss pharmacovigilance support your business needs. Scope, provider suitability and any introduction are discussed after your enquiry.
- info@swisspharmacovigilance.com
- Last reviewed: 2026-09-17