Risk management plans and aRMM

Risk management plans and additional risk management measures (aRMM)

What is a risk management plan (RMP)?

Risk Management Plans (RMPs) are one of the tools that are used to monitor medicinal products, particularly those that have been recently placed on the market. They were first introduced in 2005 and form part of the Marketing Authorisation (MA) application file. In an RMP, the marketing authorisation holder (MAH) provides a detailed description of the actions required to identify, characterise and prevent the risks associated with a medicinal product.

The risk-mitigation measures proposed by MAH are known as 'risk management measures' (RMM) 'Routine' risk-management measures (rRMM) cover the proper use of the medicinal product and are defined for all medicinal products: this information is contained in the Summary of Product Characteristics (SPC) for professionals and in the package leaflet for patients. It also appears on the packaging of the medicinal product, and in the conditions for prescribing and dispensing the medicinal product. Generally, most of the risks associated a medicinal product are covered in the rRMM. If the rRMM is considered insufficient to ensure safe and effective use, additional risk management measures (aRMMs) can be implemented for certain medicinal products.

Additional risk management measures (aRMM)

aRMM are intended to prevent or reduce the risk of undesirable effects, their severity and/or impact on patients. They can be imposed as a condition for granting the MA, but can also be established at any time after authorisation. They may include letters to healthcare professionals, information documents for healthcare professionals or patients (guides, checklists, brochures, patient cards, training slideshows, forms) or restrictions on access (controlled distribution, pregnancy prevention programme, etc.).

These documents, as well as the ways in which they are distributed to healthcare professionals and/or patients, are subject to prior approval by the Health Directorate, Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments).

How do I obtain aRMM material?

If you are a healthcare professional and wish to consult aRMM documents in electronic format, we recommend that you visit the website of the Belgian Federal Agency for Medicines and Health Products (FAMHP), where you will find aRMMs for all medicinal products from Belgium. Currently, the aRMM material for most of these medicinal products is in a version that is shared by both countries. For material that is not published on that site (older approved material), or if you wish to receive a printed version of the complete material or of certain elements, please contact the marketing authorisation holder of the medicinal product concerned. This also applies to any aRMM material relating to medicinal products from France or Germany.