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Guide to submission of Risk Minimisation Plans

11 May 2012

The risk minimisation tools requested in risk management plans (RMPs) must be assessed by the Irish Medicines Board (IMB) prior to their approval for distribution in Ireland.

Educational Materials and other risk minimisation tools intended for healthcare professionals or patients are assessed by the Vigilance Assessment team located within the Human Products Monitoring department.

For further information, click on the link to the guide below:
Guide to submission of Risk Minimisation Plans

For details of the most recent changes in the guide, click on the link below:
Guide to submission of Risk Minimisation Plans - with changes tracked

Click on the link below to download the Submissions of risk minimisation and educational materials for MAH form:
Submissions of risk minimisation and educational materials for MAH





Date Printed: 21 April 2014

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