Risk Management Plans
From July 2012, marketing authorisation holders are required have a Risk Management Plan (RMP) for any new medicine for human use and the IMB is obliged to publish summaries of these plans. An RMP is a risk mitigation tool for managing a known or potential serious risk associated with a medicine.
Summaries of RMPs will be made available on the IMB website and on the European Medicines Agency’s website. A link to the relevant section of the European Medicines Agency’s website will be provided once this information has been confirmed.
Medicines approved or submitted for approval before July 2012 may or may not have a RMP. It is important to note that products with RMPs are not necessarily associated with greater risks than products without RMPs.