Risk Management Plan "RMP"

RMPs cover a medicine's safety profile and include measures taken to prevent or minimise any harm to patients from the medicine. All medicines have both benefits and risks; a medicine is authorised only if the benefits outweigh the risks. The RMP details the known concerns about the safety of the medicine and how they can be managed. When a medicine is first authorised, it is impossible to know everything about its safety as the medicine will have been tested in relatively few patients and for a limited duration. Some side effects are very rare, or occur only in patients with other conditions or particular genetic makeup. All medicines are carefully monitored after marketing (pharmacovigilance), so that new side effects can be detected quickly, and regulatory authorities can ensure that the benefits outweigh the risks at all times. The RMP may also outline any additional studies that have been recommended at the time of licensing to provide more information on the medicine’s safety profile.

 

RMPs include information on:

 

Situations When A Risk Management Plan Should Be Submitted In Egypt