A medicine is authorised on the basis that its benefits outweigh its risks for the target population. However, not all potential or actual adverse reactions are identified by the time an initial marketing authorisation is granted. The aim of risk management is to address uncertainties in the safety profile at different points in the lifecycle, and to plan accordingly.
Marketing authorisation applicants are required to submit risk management plans, which include information on a medicine's safety profile and plans for pharmacovigilance activities designed to gain greater knowledge. They also explain how risks will be minimised in patients and how those efforts will be measured.
For full details on the risk management plan format and contents, see:
- Module V of the good pharmacovigilance practices guidelines;
- guidance on format of the risk management plan in the EU.
Submitting a risk management plan
Companies must submit a risk management plan (RMP) at the time of application for a marketing authorisation, although in some circumstances certain parts can be omitted. For medicines that do not have an RMP, one may be required to address safety concerns. All RMPs must include a summary, which distils the technical detail of the document into a public-friendly format. For centrally authorised medicines, the Agency publishes this summary alongside the European public assessment report.
RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. Companies need to submit an updated RMP:
- at the request of EMA or an NCA;
- whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.
A structured electronic representation of the RMP must also be submitted. This takes the form of the EU-RMP Annex 1, also referred to as the interface between EU-RMP and EudraVigilance.
For full details of requirements, including how and when to submit the file, see:
The form itself is set up in Visual Basic and users should select the version best suited to their operating system:
European risk management strategy
The EU Network Pharmacovigilance Oversight Group oversees performance of the pharmacovigilance system, implementing measures that allow for the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle.