‘Risk minimisation measure’ (RMM) is defined, for the purpose of this GVP Module, as an intervention intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicinal product, or to reduce their severity or impact on the patient should an adverse reaction occur.
The term ‘RMM’ is an umbrella term covering the following terms referred to in the legislation: ‘measures for ensuring the safe use of a medicinal product to be included in its risk management system’, ‘measures to prevent or minimise the risks associated with the medicinal product’, ‘interventions designed to prevent or minimise risks relating to a medicinal product’, ‘risk minimisation activities relevant to the risk-benefit assessment’, ‘regulatory action following consideration of options for risk minimisation and prevention’, and ‘other conditions or restrictions with regard to the safe and effective use of a medicinal product’.
Conceptually, a RMM consists of two components:
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RMM messages: the key information (i.e. not the full wording) about the risk and the actions intended to be taken by the healthcare professional or the patient for minimising the risk; and
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RMM tool: the tool by which the RMM messages are disseminated and adherence to the intended actions for risk minimisation is supported and/or controlled, belonging either to the category of routine or additional RMM tools (see XVI.B.2.).
