Risk Management Plan (RMP)
Preparing and maintaining risk management plans, deriving measures and demonstrating their effectiveness.
What is a risk management plan?
The risk management plan describes what is known about the safety of a medicinal product, what is still unknown and which measures are used to limit known risks. It comprises the safety specification, the pharmacovigilance plan and the risk minimisation measures, together with evidence of their effectiveness.
Why does it matter?
The RMP is part of the marketing authorisation dossier and a living document. It must be updated when new information becomes available — for example from a validated signal. An RMP that has remained unchanged since authorisation while the data have moved on is a common finding in inspections.
Who needs it?
Marketing authorisation holders with products requiring an RMP, particularly for new active substances, significant changes and extensions of indication. Also companies where a signal has triggered an update.
What do the regulations require?
- GVP Module V — risk management systems
- ICH E2E — Pharmacovigilance Planning
- GVP Module XVI — risk minimisation measures and measurement of their effectiveness
- GVP Module VIII — post-authorisation safety studies
- National and European risk procedures, including the graduated plan procedure (Stufenplanverfahren) and referrals
How VigiPRO supports you
- Preparation and revision of risk management plans
- Benefit-risk assessment of medicinal products
- Derivation and implementation of risk minimisation measures
- Creation of educational material for healthcare professionals and patients
- Support in national and European risk procedures
Why VigiPRO
Because signal management and the RMP sit within the same team at VigiPRO, a validated signal actually becomes an RMP update — rather than a note that gets stuck between two areas of responsibility.
Frequently asked questions
When does an RMP have to be updated?
At the request of the authority, at milestones of the pharmacovigilance plan and whenever new information affects the safety specification or the measures — for example after a validated signal.
Do generics need their own RMP?
That depends on the active substance and the conditions of the procedure. If the reference medicinal product carries particular risks with additional measures, an RMP is usually required for the generic as well.
How do you demonstrate the effectiveness of a measure?
Using indicators defined in advance — for example surveys of healthcare professionals’ knowledge or analyses of prescribing behaviour. What matters is that the metric is defined before the measure starts.
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