RISK MANAGEMENT
PLAN (RMP)
A set of Pharmacovigilance
activities and interventions designed to proactively identify, characterize and
prevent or minimize risks relating to Medicinal Products, including risk
communication and the assessment of the effectiveness of risk minimization and
interventions.
A Risk Management Plan (RMP)
provides information on a medicine's safety profile, describes the activities
of the marketing authorization holder to further characterize the safety
profile during post-marketing (pharmacovigilance activities), and explains the
measures that are taken in order to prevent or minimize the medicine’s risks in
patients (risk minimization measures). A RMP should be submitted as part of the
dossier of all new drug applications including generics and national applications
and is evaluated by regulatory authorities before a medicine can be authorized.
An RMP can also be requested by regulatory authorities for already authorized
products that do not have an RMP in place yet when there is a concern about a
risk affecting the benefit-risk balance. The RMP should include information on:
•
a medicine's safety profile describing the
important identified and potential risks;
•
plans for studies and other activities to gain
more knowledge about the safety and efficacy of the medicinal product
(pharmacovigilance activities);
•
how its risks will be prevented or minimized in
patients
•
measuring the effectiveness of risk-minimization
measures.
Detailed guidance on the content,
format and submission of RMPs is available in the Guideline on good
pharmacovigilance practices (GVP)-Module V-Risk management systems. The
template for the EU-RMP can be found on the EMA website. RMPs are continually
modified and updated throughout the lifetime of the medicine as new information
becomes available. Marketing authorization holders need to submit an updated
RMP:
•
at the request of the EMA, MEB or other national
competent authority;
•
whenever the RMP is modified, especially as the
result of new information being received that may lead to a significant change
to the benefit-risk profile or as a result of an important pharmacovigilance or
risk-minimisation milestone being reached.
When justified by risk,
the authorities can also specify a date for submission of the next RMP as a
condition of the marketing authorisation in exceptional cases.
Risk Minimisation Measures
•
Risk minimisation measures are interventions
intended to prevent or reduce the occurrence of adverse reactions associated
with the exposure to a medicine, or to reduce their severity or impact on the
patient should adverse reactions occur.
•
Risk minimisation measures can consist of
routine risk minimisation or additional risk minimisation measures.
•
Routine risk minimisation is applicable to all
medicinal products, and involves the use of the summary of product
characteristics (SmPC); the package leaflet; the labelling; the pack size and
design; the legal (prescription) status of the product.
•
For some risks routine risk minimisation
measures are not sufficient and additional measures are required. The
additional risk minimisation measures for a medicinal product are specified as
a requirement in the Risk Management Plan (RMP). A variety of tools are currently
available for additional risk minimisation such as educational materials,
controlled access programmes or a pregnancy prevention programme. This field is
continuously developing, and new tools are likely to be developed in the
future. Technology advances, such as interactive web-based tools may gain
prominence in the future in addition to the paper-based materials.
•
Before additional risk minimisation measures can
be implemented in the Netherlands the Dutch proposal must be assessed at
national level by the MEB. Only approved risk minimisation measures can
be distributed in the Netherlands. The MEB offers specific guidance for
marketing authorisation holders on the additional risk minimisation measures
intended for the Netherlands.
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