Risk minimisation measure (RMM); synonym: Risk minimisation activity

Interventions 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. Conceptually, a RMM consists of two components:

• 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
• 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 RMM tools (summary of product characteristics, package leaflet, labelling of immediate and outer packaging, pack size, classification of the medicinal product) or additional RMM tools (e.g. educational/safety advice tools, Risk minimisation control tools).

RMM messages can be verbally explicit or non-verbal implicit (e.g. a restricted pack size as a RMM tool may imply e.g. the message that overdose is a specific risk to be avoided or that medical supervision of the treatment with this medicinal product is required; also a risk minimisation control programme, e.g. a traceability system or healthcare facility accreditation required for using a given medicinal product, carry implicit messages for the target audience); however, there will always be verbal messages at least in the product information and, if applicable, in further RMM materials.

For a specific medicinal product, a RMM material is the final individual RMM with its full wording in the local language(s) as approved by the competent authorities.