Risk management plans for medicines and biologicals

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12 December 2017

What is an RMP?

An RMP is a detailed description of a risk management system. The RMP essentially contains:

  • A description and analysis of the safety profile of the medicine or biological including a summary of the safety concerns; and
  • A set of product vigilance and risk minimisation activities designed to identify, characterise and manage risks relating to the medicine or biological including the assessment of the effectiveness of these activities and interventions.

The RMP covers the entire life cycle of the product. Therefore, you will need to update it periodically to reflect new knowledge and understanding of the products’ safety profile and benefit‐risk balance.

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