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. An 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. RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. For medicinal products authorised through national procedures, both during the authorisation and post-authorisation phases, RMPs are submitted to the NAMMDR for assessment and approval.
The format and content of the RMP should follow the requirements set out in Commission Implementing Regulation No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in regulation (EC) No 726/2004of the European Parliament and of the Council and 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 the Guideline on good pharmacovigilance practices (GVP) – Module V – Risk management systems.
The template for the EU-RMP is also available on the EMA website: Guidance on the format of the risk management plan (RMP) in the EU – in integrated format.
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.
Information on procedural and regulatory aspects relating to RMPs for medicinal products 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.
Summaries of risk management plans
Public summaries of RMPs for medicinal products authorised through the centralised procedure are available on the EMA website.
Summaries of RMPs for medicinal products authorised through national procedures (including through the decentralised or mutual recognition procedure) are publicly accessible on the NAMMDR website in section Risk Management Plans (RMPs), according to art. 833 letter (c) of Law 95/2006 on the health reform.
MAHs are recommended to use the following template for submission of summary of RMP in Romanian language to NAMMDR:
Since the name of the medicinal products sometimes are changed, there can be differences between the names in the summary of RMPs and the most recently approved names for the respective medicinal products.
The summary of the RMP for a medicinal product should be always read in the context of all product information available, including the Summary of Product Characteristics and Package Leaflet. Summary of Product Characteristics and Package Leaflets for medicinal products authorised in Romania are available in Medicinal Product Index, at the following link: https://nomenclator.anm.ro/medicamente.
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 the following EMA Good Pharmacovigilance Practice Guidelines (Good pharmacovigilance practices – GVP):
- GVP Module V – Risk management systems,
- GVP Module XVI – Risk minimisation measures (Rev 3),
- GVP Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures
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 measures are: educational materials/ educational or safety advice tools relating to specific risks associated with the medicine and how to prevent/minimise them (for healthcare professionals and patients/caregivers), controlled access programmes, pregnancy prevention programmes.
There are other types of safety communications, such as direct communications to healthcare professionals, which may also be used to communicate a particular safety issue to healthcare professionals so that they can take certain actions or adapt their practices in relation to a medicinal product. More information on safety communications is available in the EMA’s Good Pharmacovigilance Practice Guideline – Module XV – Safety communication (Rev 1).
The NAMMDR approves educational materials which are disseminated in Romania by the marketing authorisation holder (MAH) for their medicinal products. The approved educational materials are published on the NAMMDR website since 2023, available in section Educational Materials.
The NAMMDR has developed instructions for MAHs to provide detailed information on how to approve educational materials, which are available here.