XVI.B.6. Adapting risk minimisation measures within the benefit-risk management cycle of the medicinal product

Within the benefit-risk management cycle for a medicinal product (see XVI.B.1.1.) in the postauthorisation phase, it may be necessary to adapt existing RMM, i.e. to:

• Amend existing RMM in terms of e.g. the risk information, intended clinical action, target populations, tool, design of materials or dissemination plan;
• Discontinue one or more of the existing additional RMM; or
• Introduce new RMM.

When considering adapting existing RMM, marketing authorisation holders and competent authorities should apply the points to consider in Table XVI.4. and Table XVI.10.

Engagement with patient and healthcare professional representatives (see XVI.B.1.4.) may support the considerations for adapting existing RMM, the development of amended or new RMM materials and/or dissemination plans (see XVI.B.4.) and the implementation of adapted RMM in healthcare (see XVI.B.1.3.).

Any proposal for adapting RMM for a medicinal product should be accompanied by a rationale and the underlying evidence or other relevant information. The marketing authorisation and the RMP, if the medicinal product has a RMP, should be updated with the agreed RMM adaptations (see XVI.C.1.).

If amendments to additional RMM materials have been agreed, a national dissemination plan should be implemented (see XVI.B.4.2.).

XVI.B.6.1. Impact of adapted risk minimisation measures on requiring studies evaluating their effectiveness

Adaptations to the RMM (see XVI.B.6.) or inconclusive results of studies evaluating RMM effectiveness (see XVI.B.5.4.) may require a new study to evaluate existing, amended or new RMM or the impact of discontinuing a RMM material (see XVI. B.5.).

The RMP is to be updated accordingly (see XVI.C.1.2.).