V.B.1. Principles of risk management

The overall aim of risk management is to ensure that the benefits of a particular medicinal product exceed the risks by the greatest achievable margin. The primary aim and focus of the RMP remains that of appropriate risk management planning throughout a medicinal product’s life cycle. The risk management system shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data [DIR Art 8(3)].

The RMP is a dynamic document that should be updated throughout the life cycle of the product(s). This includes the addition of safety concerns where required, but also, as the safety profile is further characterised, the removal or reclassification of safety concerns.

The guidance on risk classification in this document may facilitate that during the life cycle of the products the list of safety concerns in the RMP will be reduced (see also V.A.1. and V.B.5.8.):

• It may be that important potential risks can be removed from the safety specification in the RMP (e.g. when accumulating scientific and clinical data do not support the initial supposition, the impact to the individual has been shown to be less than anticipated resulting in the potential risk not being considered important, or when there is no reasonable expectation that any pharmacovigilance activity can further characterise the risk), or they need to be reclassified to ‘important identified risks’ (e.g. if scientific and clinical data strengthen the association between the risk and the product).
• In certain circumstances, where the risk is fully characterised and appropriately managed, important identified risks may be removed from the safety specification (e.g. for products marketed for a long time for which there are no outstanding additional pharmacovigilance activities and/or the risk minimisation activities recommending specific clinical measures to address the risk have become fully integrated into standard clinical practice, such as inclusion into treatment protocols or clinical guidelines).
• Given the overall aim of obtaining more information regarding the risk-benefit balance in certain populations excluded in the pre-authorisation phase, it is expected that as the product matures, the classification as missing information might not be appropriate anymore once new data become available, or when there is no reasonable expectation that the existing or future feasible pharmacovigilance activities could further characterise the safety profile of the product with respect to the areas of missing information.

With the exception of some patient registries, it is expected that over time the additional pharmacovigilance activities in the RMP will be completed and thus removed from the RMP.

The need to continue additional risk minimisation activities may change, as the recommendations for specific clinical measures to address the risk become part of the routine practice such as inclusion into standard treatment protocols in the EU, or in response to the findings of effectiveness of risk minimisation evaluations (i.e. they may need to be replaced with more effective activities). Some risk minimisation activities might be needed to be retained for the lifetime of the medicinal product (e.g. pregnancy prevention programmes).