Risk management plans and aRMM

Risk Management Plans and Risk Mitigation Activities (RMA)

What is a Risk Management Plan (RMP)?

A Risk Management Plan (RMP) is a tool used in the postmarketing surveillance of medicines, particularly those recently introduced to the market. They were first implemented in 2005 and are part of the Marketing Authorization Application (MA). In an RMP, the marketing authorization holder describes in detail the actions necessary to identify, characterize, and prevent the risks associated with a drug.

The measures proposed by the marketing authorization holder to reduce these risks are called Risk Minimization Activities (RMA). So-called “routine” measures (rRMAs) govern the proper use of the drug and are defined for all drugs: these include the information included in the Summary of Product Characteristics (SPC) for healthcare professionals and in the patient information leaflet, the drug’s packaging, or the establishment of prescribing and dispensing conditions. In general, the risks associated with most medicines are sufficiently mitigated by rRMAs. For certain medicines, however, these measures are considered insufficient to ensure safe and effective use; in such cases, additional risk minimization activities (aRMAs) are implemented.

Additional Risk Minimization Activities (aRMA)

aRMA are intended to prevent or reduce the likelihood of adverse events occurring, their severity, and/or their impact on the patient. They may be required as a condition for marketing authorization, but they may also be mandated at any time after authorization. These may include letters to healthcare professionals, informational materials for healthcare professionals or patients (guides, checklists, brochures, patient cards, training presentations, forms), or access restrictions (controlled distribution, pregnancy prevention programs, etc.).

These documents, along with the procedures for distributing them to healthcare professionals and/or patients, are subject to prior authorization by the Health Directorate, Division of Pharmacy and Medicines.

How can you obtain aRMA materials?

If you, as a healthcare professional, wish to view aRMA documents in electronic format, we invite you to visit the website of the Belgian Federal Agency for Medicines and Health Products (AFMPS) for all medicines originating in Belgium. Currently, the aRMA materials for most of these medicines are available in a version common to both countries. For materials not published on this website (older, previously approved products) or if you wish to receive a printed version of the complete materials or specific sections, please contact the marketing authorization holder for the relevant drug to obtain them. This approach also applies to all aRMA materials related to drugs originating from France or Germany.