You are here

Risk management plans for medicines and biologicals

Version 3.3, March 2019

29 March 2019

Book pagination

This guidance is for sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries. It describes the risk management plan (RMP) requirements.

This guidance:

  • describes what an RMP is
  • explains when you must submit an RMP with an application for registration, inclusion or variation in the ARTG
  • describes what to include in an RMP and the required format for RMPs
  • details special requirements for RMPs for biologicals and generics
  • outlines how we evaluate RMPs
  • explains when to submit RMP updates after regulatory approval, and
  • describes how we monitor your compliance with RMP commitments.

Risk management plans for medicines and biologicals

How to access a pdf or Word document

We aim to provide documents in an accessible format. If you're having problems using this document, please contact RMP Coordinator.

Contents

  • About this guidance
  • What is an RMP?
  • When an RMP is required
  • How to tell us if you will be submitting an RMP with an application
  • RMP format
  • Australia-specific annex to the EU RMP
  • Evaluation process for Risk Management Plans
  • Submitting RMP updates after regulatory approval
  • Periodic Safety Update Reports
  • Monitoring compliance with RMP commitments
  • Risk Management Plan - Australia-Specific Annex
  • Contact information
  • Version history

Book pagination