Risk Management Plans (RMPs)
A risk management plan (RMP) is a document that describes the current knowledge about the safety and efficacy of a medicinal product. The RMP provides key information on plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine. It also describes measures to be undertaken to prevent or minimise risks associated with the use of the product in patients. Marketing authorisation holders (MAHs) are required to have an RMP for any new medicinal product for human use which must be submitted at the time of application for marketing authorisation. For nationally authorised products RMPs must be submitted to the HPRA for review and approval. RMPs are modified and updated with new information that becomes available during the lifecycle of a medicinal product.
The format and content of the RMP should follow the requirements set out in Commission Implementing Regulation on the performance of pharmacovigilance activities provided for in regulation (EC) No 726/2004 and Directive 2001/83/EC of the European Parliament and of the Council. Further information on RMPs and guidance on their format are available on the EMA website and in Module V of the Guideline on Good Pharmacovigilance Practices (GVP).
Further information on procedural and regulatory aspects relating to RMPs for medicinal products authorised through the centrally authorised procedure is available via the EMA Q&A on RMPs.
Public summaries of RMPs for products newly authorised through the centralised procedure since March 2014 are available on the EMA website.
Information relating to RMPs for medicinal products newly authorised through the decentralised or mutual recognition procedure (including the List of safety concerns per approved RMP of active substances per product) is available on the CMDh –RMP section of the HMA website
Risk Minimisation Measures
Risk minimisation measures are interventions used to enhance the benefit/risk balance of a medicinal product. Their aim is to prevent or reduce the occurrence of adverse reactions associated with the medicinal product or reduce the severity or impact on the patient should adverse reactions occur. Guidance on risk minimisation measures is provided in GVP Module V – Risk management systems and also in Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators.
Risk minimisation measures are outlined in the risk management plan for a particular product. Routine risk minimisation measures are applied to every medicinal product (e.g. information in the summary of product characteristics, patient information leaflet, labelling). For some medicines additional risk minimisation measures are required. Examples of additional risk minimisation tools are educational materials relating to specific risks associated with the medicine and how to mitigate them (for healthcare professionals and patients or carers), controlled access programmes and pregnancy prevention programmes. The HPRA reviews and approves educational materials submitted nationally by MAHs for their medicinal products and these are published on our website (see Educational Materials for Medicines for further information). Other types of safety communications, such as Direct Healthcare Professional Communications (DHPCs), may also be used to communicate a particular safety issue to healthcare practitioners so that they take certain actions or adapt their practices in relation to a medicinal product. More information on safety communications is given in GVP Module XV – Safety communication.
The HPRA has developed a guideline to advise on the submission of risk minimisation measures. The guideline can be found here.