| Medicines authorised between 2006 and 2017 without additional risk minimisation measures (aRMMs) have a low probability that aRMMs will be introduced within 5 and 10 years after authorisation, and medicines authorised with aRMMs during that period have a low probability that aRMMs will be discontinued. |
| Post-authorisation introduction of aRMMs is most often triggered by new safety information arising from spontaneous reports or clinical trials. |
| The role of effectiveness evaluation of aRMMs in the life cycle management of medicines is currently unclear. |
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