Risk Management Plans (RMPs)
The overall aim of risk management plan (RMP) is to ensure that the benefits of a particular medicinal product exceed the risks. A RMP is a mandatory document that identify, characterise and minimise a medicinal product’s important risks in terms of safety. The RMP provides key information on plans for studies and other activities to gain more knowledge about the product’s safety profile. It also describes measures to be undertaken to prevent or minimise risks associated with the use of the medicinal 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 NAMMDR for assessment and approval. The RMP is a dynamic document that should be updated throughout the life cycle of the 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, Directive 2001/83/EC of the European Parliament and of the Council and Law no. 95/2006 on healthcare reform. 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 on procedural and regulatory aspects 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 minimise the occurrence of adverse reactions associated with the medicinal product or to reduce the severity or impact on the patient if 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, also in GVP Module XVI Addendum I – Educational materials
Risk minimisation measures are outlined in the risk management plan for a particular medicinal 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.
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 NAMMDR reviews and approves educational materials (set as additional risk minimisation measures) which are disseminated in Romania by MAHs for their medicinal products.
The approved educational materials (which are additional risk minimisation measures) are published on the NAMMDR website since 2023, available in section Educational Materials.
The NAMMDR has developed instructions to advise MAHs on the submission for approval of educational materials. The instructions are available here.