risk management plan (rmp)
Companies are required to submit a Risk Management Plan (RMP)
along with any request for marketing authorisation for a new
medicinal product. This plan provides safety specifications. This
is a summary of knowns and unknowns regarding the medicinal
product’s risk profile gathered during the development phase.
The Guideline on risk management systems for
medicinal Products for human use contains all required
information regarding the structure and contents of Risk
Management Plans.
Risk Management Plans offer an opportunity to pursue a pro-active
approach alongside a reactive approach (reacting to reports of
adverse events). The Risk Management Plan contains agreements about
the best way to deal with the risks associated with medicinal
product use. Companies must submit proposals for further research
to complete any gaps in information, along with a timetable.
Once a marketing authorisation has been granted, RMP
progress reports must be submitted, ideally simultaneously with
the PSURs.
If the authorities become aware of a safety problem with a product
that has been granted marketing authorisation, they can ask the
marketing authorisation holder to draft and implement an RMP.
Risk Minimisation Plan
The Risk Minimisation Plan is an important part of a Risk
Management Plan. Risk Minimisation Plans describe which actions
manufacturers have planned to minimise risks.
Measures can be divided into routine risk minimisation measures
and additional risk minimisation measures:
- Routine risk minimisation measures are, for example,
contraindications or warnings in the Summary of Product
Characteristics (SmPC) and the legal status of a product.
- Examples of additional risk minimisation measures are:
-
- Additional educational materials for doctors, pharmacists
and/or patients
- Informed consent and other patient aspects
- Limiting availability (use only if patients take part in a
special monitoring programme, for example)
-
Pregnancy Prevention Programme (PPP)
It should be emphasised that an assessment of the Risk
Minimisation Measures (RMM) by the MEB is required. Only products
with approved RMM are allowed to be marketed.
More information