Risk Management Plan (RMP)

Risk Management Plan

EU: Directive 2001/83/EC – A detailed description of the risk management system (as per Article 1(28c) of Directive 2001/83/EC).

EU: Regulation EU/520/2012 – 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 (as per Article 30(1) of Implementing Regulation EU/520/2012)….See also Risk management system, Risk minimisation measure