Risk management plan for Switzerland

The risk management plan for Switzerland

A risk management plan describes a product's important identified and potential risks, the missing information, and the measures that address them. For Switzerland an EU RMP is adapted rather than copied: Swiss contacts, the wording of the Swiss product information, the real Swiss distribution set-up and the language versions of any educational material.

Last reviewed: 2026-09-17

Reading time: 4 min

Reviewed by Swiss Pharmacovigilance

What is an RMP, and when is one required?

An RMP is the document in which a holder states what it does not yet know about a product and how it will manage that uncertainty. Swissmedic requires one where the safety profile warrants it, typically for new active substances, products with a significant identified risk, and products whose safe use depends on measures beyond the product information.

Adapting an EU RMP for Switzerland

The safety specification and the pharmacovigilance plan usually transfer unchanged, because the science is the same. What has to change is everything that touches the Swiss market: who to contact, what the approved Swiss text actually says, who distributes the product here, and in which languages the material reaches its audience.

Swiss contact details and the named RPPV instead of the EU QPPV
Quotations from the Swiss product information rather than the EU SmPC
Swiss distribution reality: which channels, which dispensing category
Language versions of every patient and professional facing material
Swiss exposure figures where they exist, and an honest note where they do not
Swiss specific commitments, and the removal of EU commitments that do not apply

Routine and additional measures

Routine risk minimisation is the product information, the pack, the dispensing category and the legal status. Additional measures are everything you have to do because those are not enough. The distinction matters because additional measures need agreement with Swissmedic, a rollout, and an effectiveness assessment.

Routine: the Swiss product information and patient leaflet wording
Routine: pack size, presentation and the dispensing category
Additional: educational material for prescribers or dispensers
Additional: a patient card or alert card
Additional: a pregnancy prevention programme
Additional: controlled access or a prescriber certification requirement
Additional: a registry or a post-authorisation safety study

Measure, implementation and indicator

A measure without an indicator cannot be reported on, and a measure that is not reported on is treated as not working. Define the indicator when you design the measure, not when the PSUR is due.

Risk minimisation measures and their effectiveness indicators
Measure type	Example	Swiss implementation	Effectiveness indicator
Educational material	Dosing and monitoring guide for prescribers	Distributed in German, French and Italian through the Swiss channel	Distribution coverage and a prescriber awareness survey
Patient card	Alert card for a serious identified risk	In the pack or handed out at dispensing, in the site language	Card possession rate among treated patients
Pre-treatment checklist	Baseline tests before the first dose	Agreed with Swissmedic and issued with the material	Proportion of patients with documented baseline tests
Pregnancy prevention	Testing and contraception requirements	Programme documents plus a controlled dispensing route	Pregnancy exposure rate and protocol adherence
Controlled access	Dispensing only through certified centres	Agreed centre list, documented in the RMP	Share of dispensing outside the intended route
Registry or study	Post-authorisation safety study	Swiss participation or a Swiss cohort	Enrolment against target and interim findings

Educational material in a four-language market

Switzerland turns one deliverable into three or four. The material has to exist in the languages of the regions where the product is dispensed, the versions have to say the same thing, and the translation has to be reviewed by someone who knows the therapeutic area rather than only the language. Plan six to eight weeks for translation, review and Swissmedic agreement, and budget for revising all versions whenever the product information changes.

Measuring effectiveness and reporting it

Effectiveness is assessed against the indicator you defined and reported in the PSUR. Distribution numbers alone are process metrics, not effectiveness: they show the material left the building, not that behaviour changed. Where an indicator shows a measure is not working, say so and propose a change; a measure reported as effective for five years with no supporting data is worse than an honest negative.

Frequently asked questions

Does every product need an RMP in Switzerland?

No. Swissmedic requires one where the safety profile warrants it, in particular for new active substances and for products whose safe use depends on measures beyond the product information. Established products often manage with routine measures alone.

Can we submit the EU RMP as it stands?

The safety specification and pharmacovigilance plan usually transfer. What has to be adapted is the Swiss contact details, the quotations from the Swiss product information, the distribution reality and the language versions of any material.

Who approves educational material in Switzerland?

Additional risk minimisation material is agreed with Swissmedic before it is distributed. Plan the agreement step into your timeline rather than printing first and asking afterwards.

In how many languages do we need the material?

In the languages of the regions where the product is dispensed, which in a nationally distributed product means German, French and Italian, with English often added for hospital specialists. All versions have to be consistent with each other.

How do we show a measure is effective?

Against the indicator you defined in the RMP, reported in the PSUR. Distribution coverage is a starting point, but an awareness or behaviour measure is what demonstrates effectiveness.