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 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.

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 submission of RMPs is available on the EMA website and in Module V of the Guideline on Good Pharmacovigilance Practices.

The European Medicines Agency (EMA) and national competent authorities are adopting a risk based approach to RMP updates and there is no longer an automatic requirement to update RMPs on a fixed time basis. An updated RMP should now be submitted by way of variation;

  • At the request of the EMA, HPRA other national competent authority
  • Whenever the RMP is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile of a medicinal product or as a result of an important pharmacovigilance or risk minimisation milestone being reached.

If the date for the submission of a periodic safety update report and the need to update an RMP coincide, both can be submitted at the same time.  

The HPRA is obliged to publish summaries of RMPs. These will be made available on the HPRA website and on the European Medicines Agency’s website in due course.

Risk Minimisation Measures

Risk minimisation tools are used to enhance the benefit/risk balance of a medicinal product. They do this by preventing or reducing the occurrence of adverse reactions associated with the medicinal product or reducing the severity of reactions that do occur. The EMA provides guidance on risk minimisation measures in their Good Pharmacovigilance Practices in Module V – Risk management systems and also in Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators.

Risk minimisation measures are outlined the risk management plan for a particular product. The most common types of risk minimisation tools are educational programmes, controlled access programmes and pregnancy prevention programmes. Other types of safety communications, such as Direct Healthcare Professional Communications (DHPCs), are sometimes used as risk minimisation measures, in order to communicate a particular safety issue to practitioners, patients, or carers. 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.