1. The Risk Management Plan (RMP)

1.2. The ‘safety specification’ or the characterisation of the safety profile

The purpose of the safety specification is to provide an adequate description on the safety profile of the medicine (s), and specifically those aspects that need further risk management activities. It includes a summary of the important identified risks of a medicine, important potential risks, and missing information. It should also address the populations potentially at risk (where the product is likely to be used i.e., both as authorised and off-label use), and any outstanding safety questions (e.g., inherent to the medicine itself like toxicity, or related to the intended indication) that warrant further investigation to refine the understanding of the risk-benefit balance during the post-authorisation period. The safety specification forms the basis of the pharmacovigilance plan and the risk minimisation plan.

Finally, the perception of the risk is also an important aspect to take into consideration:

  • The level of acceptance of the risk is usually low or there is no tolerance of any risk, when the medicine is intended to prevent a disease or to treat a non-life-threatening condition, e.g. vaccination or treatment of acne. This applies also if the target population is especially vulnerable (e.g. children) or except the intended indication young and healthy (e.g. young women and endometriosis);
  • The level of acceptance of the risk is high when there are no or few therapeutic options for a life-threatening condition; e.g., second-line of chemotherapy for a metastatic cancer (a cancer that has spread).