Spring Intro 2023

16/02/2023

Risk Minimisation Measures (RMMs)

Additional risk minimisation measures (aRMMs) include educational material(s) aimed to minimise important risks and/or to maximise the risk benefit balance of a medicinal product.

Example: rituximab EdTs available on emc: https://www.medicines.org.uk/

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Why Important?

• Should provide clear statements and concise messages describing actions to be taken in order to prevent and minimise risks

• Content must be aligned to SmPC/PL but should add to rather than replicate this information

• The need for educational materials may be agreed at time of: • Initial MA • Post-authorisation e.g. after introduction of a new RMP or an update of an existing RMP, significant change to safety profile.

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