risk minimisation measures

Formal Definition

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. These activities may consist of routine risk minimisation measures (the summary of product characteristics, the package leaflet, the labelling, the pack size, the legal status of the product, and its formulation) or additional risk minimisation measures (educational programmes, controlled access programmes, other additional risk minimisation measures).