cover image: 09 GVP Module Risk Minimisation Measures Rev 2 - Superseded published

09 GVP Module Risk Minimisation Measures Rev 2 - Superseded published

5 Aug 2024

Each safety concern needs to be individually considered and the selection of the most suitable risk minimisation measure should take into account the seriousness of the potential adverse reaction(s) and its severity (impact on patient), its preventability or the clinical actions required to mitigate the risk, the indication, the route of administration, the target population and the healthcare set. [...] Risk minimisation measures should therefore guide optimal use of a medicinal product in clinical practice with the goal of supporting the provision of the right medicine, at the right dose, at the right time, to the right patient and with the right information and monitoring. [...] The performance of these measures in healthcare systems requires assessment to ensure that their objectives are fulfilled and that the measures in place are proportionate taking account of the risk-benefit balance of the product and the efforts required of healthcare professionals and patients to implement the measures. [...] The nature of the safety concern in the context of the risk-benefit balance of the product, the therapeutic need for the product, the target population and the required clinical actions for risk minimisation are factors to be considered when selecting risk minimisation tools and developing an implementation strategy to accomplish the desired public health outcome. [...] Competent authorities in Member States The national competent authorities are responsible for the oversight at national level of the implementation of additional risk minimisation measures imposed as a condition of the marketing authorisation for the safe and effective use of a medicinal product in the EU, irrespective of the route of marketing authorisation.

Authors

European Medicines Agency

Organizations mentioned

Pages
23
Published in
Malta

Table of Contents