Risk management plan (RMP)

A detailed description of the risk management system [DIR 2001/83/EC Art 1(28c)].

The risk management plan established by the marketing authorisation holder shall contain the following elements: (a) an identification or characterisation of the safety profile of the medicinal product(s) concerned; (b) an indication of how to characterise further the safety profile of the medicinal product(s) concerned; (c) a documentation of measures to prevent or minimise the risks associated with the medicinal product, including an assessment of the effectiveness of those interventions; (d) a documentation of post-authorisation obligations that have been imposed as a condition of the marketing authorisation [IR 520/2012 Art 30(1)].

See also Risk management system, Risk minimisation measure