Monday, October 22, 2018

RISK MANAGEMENT PLAN (RMP) - Pharmacovigilance-Material


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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