XVI.B.3. Requiring and selecting tools of additional risk minimisation measures

For the purpose of risk minimisation, all information shall be evaluated scientifically, options for risk minimisation be considered and appropriate RMM be taken as necessary [based on DIR Art 104(2) and DIR Art 101(2)].

Careful consideration should be given to whether the intended RMM outcomes (see XVI.B.1.2.) could be achieved with routine RMM tools alone. Most risks will be sufficiently addressed by routine RMM tools (see XVI.B.2.2.). Additional RMM tools (see B.2.3.) should be required only if they are considered necessary for keeping the risk-benefit balance of the medicinal product positive. Generally, additional RMM tools address important identified or important potential risks (see GVP Annex I).

In determining whether additional RMM tools are necessary and selecting the respective tool(s), marketing authorisation holders and competent authorities should consider the points in Table XVI.4. and use past and formative evidence (see XVI.B.1.1.) as well as input that may be sought from patients and healthcare professionals (see XVI.B.1.4.). Applying these points to consider should lead to selecting and developing RMM that are specific to the given medicinal product, the risk, the patient population and the healthcare context.

Selecting several educational/safety advice tools may be warranted for reaching as many as possible among the target population.

Specifically for medicinal products which may adversely affect the embryo/foetus/child at conception, in utero or through breastfeeding, routine and additional RMM tools can be combined to prevent adverse pregnancy outcomes (see GVP Module XVI Addendum I).

Each risk needs to be considered individually, but an additional RMM material may address more than one risk.

XVI.B.3.1. Risk minimisation control programmes

A risk minimisation control programme applies risk minimisation control tools (see XVI.B.2.3.2.) in addition to routine RMM tools (which may include, if applicable, e.g. pack size restrictions (see XVI.App.1.4.) or specific requirements for the legal status (see XVI.App.1.5.)) and educational/safety advice tools (see XVI.B.2.3.1.).

Such a programme should be considered in rare situations where a serious risk may have a specifically severe impact on the patient and/or public health, which is considered not to be effectively minimised by routine RMM together with educational/safety advice tools alone. These situations may include e.g. risks with possible severe impact for the embryo/foetus/child due to adverse effects of a medicinal product at conception, in utero or through breastfeeding (see GVP Module XVI Addendum I), risks associated with misuse or abuse of a medicinal product with possible severe impact on patient and public health, and risks with advanced therapy medicinal products (ATMPs) that may require specific traceability.