Adapting and running a risk management plan for Switzerland
External providers take your EU RMP and make it Swiss: local contacts, the wording of the Swiss product information, the real Swiss distribution set-up, and educational material in the languages where the product is dispensed. Then external providers run the additional measures, measure whether they work and report that in the PSUR.
- Last reviewed:
- Reading time: 3 min
- Reviewed by Swiss Pharmacovigilance
What this service is
A regulatory and operational service covering the whole life of a risk minimisation measure: adapting the document, agreeing the material with Swissmedic, producing the language versions, distributing them, and assessing effectiveness against an indicator defined up front.
What you get
- A Swiss adapted RMP, with the changes from the EU version listed and justified
- Swiss contact details, the named RPPV and the Swiss distribution reality
- Quotations aligned to the approved Swiss product information
- Educational material designed and produced in up to four languages
- Agreement of the material with Swissmedic before distribution
- A distribution plan for the Swiss channel, executed and documented
- Effectiveness indicators defined per measure, and the data collection behind them
- The effectiveness section for your PSUR
How external providers run it
- Gap analysis: read the EU RMP against the Swiss authorisation and market.
- Adapt the document and list every change with its rationale.
- Design each additional measure with its effectiveness indicator attached.
- Produce and review the language versions with therapeutic area review, not only translation.
- Agree the material with Swissmedic and incorporate their comments.
- Distribute through the Swiss channel and record who received what.
- Collect the indicator data and write the effectiveness assessment for the PSUR.
What external providers need from you
- The current EU RMP and any commitments attached to it
- The approved Swiss product information and any pending variations
- The Swiss distribution set-up: channels, dispensing category, partners
- The therapeutic area contact who can review a translation for substance
| Measure | Swiss implementation | Effectiveness indicator |
|---|---|---|
| Prescriber guide | German, French and Italian, distributed through the Swiss channel | Distribution coverage plus an awareness survey |
| Patient alert card | In pack or handed out at dispensing, in the site language | Card possession rate among treated patients |
| Pre-treatment checklist | Issued with the prescriber guide, agreed with Swissmedic | Documented baseline tests before first dose |
| Pregnancy prevention programme | Programme documents plus a controlled dispensing route | Pregnancy exposure rate, protocol adherence |
| Controlled access | Agreed centre list documented in the RMP | Share of dispensing outside the intended route |
| Registry participation | Swiss cohort or participation in an existing registry | Enrolment against target, interim findings |
Onboarding
- Week 1 to 2: gap analysis of the EU RMP against the Swiss authorisation.
- Week 3 to 4: adapted RMP drafted, measures and indicators defined.
- Week 5 to 8: material produced and reviewed in the required languages.
- Week 8 to 12: agreement with Swissmedic, then distribution and data collection start.
Pricing model
The RMP adaptation is a fixed fee per product. Material production is priced per deliverable per language, with translation and therapeutic review itemised. The recurring effectiveness data collection and reporting is a small annual fee per measure, so you can see what each measure costs to keep running.
Frequently asked questions
Can external providers submit the EU RMP unchanged?
The safety specification and pharmacovigilance plan usually transfer. The Swiss contacts, the product information quotations, the distribution reality and the language versions of any material have to be adapted, and Swissmedic notices when they have not been.
How many languages do external providers need?
The languages of the regions where the product is dispensed, which for national distribution means German, French and Italian, often with English for hospital specialists. All versions have to say the same thing.
What does the adaptation cost?
A fixed fee per product for the document, plus per deliverable per language for material, plus a small annual fee per measure for effectiveness data. You get the breakdown before external providers start.
Who agrees the material with Swissmedic?
External providers draft and submit it and handle the exchange, with you approving the content before it goes. The agreement step has to happen before distribution, so it belongs in the timeline rather than after printing.
What if a measure turns out not to work?
External providers report that honestly in the PSUR and propose a change. A measure reported as effective for years with no supporting data is a worse position than an acknowledged negative with a plan.
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.