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ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines

Version 1.3, April 2014

29 November 2015

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This interim guideline details the new regulatory processes for the approval of new and changed OTC medicines. The new process is to be implemented in stages. This guideline describes the process that will apply when fully implemented and is to be read in conjunction with the guidance regarding the implementation stages for the new process. The initial stages of implementation allow more flexibility around the process and greater opportunity for the sponsor to remedy incorrectly submitted applications. Where the requirements detailed in this guideline differ during the stages of implementation, this will be highlighted throughout.

This guideline will be updated and revised as needed throughout the staged implementation of the new process.

The new process uses a risk based approach to regulating OTC medicines and aims to:

  • deliver more efficient and cost-effective OTC medicines evaluation processes
  • provide greater transparency and predictability of the regulatory process
  • ensure consumers have timely access to safe and effective OTC medicines
  • harmonise the OTC medicines evaluation processes in Australia and New Zealand
  • improve the quality of OTC medicine applications
  • ensure an appropriate benefit/risk model is applied to approvals of OTC medicines
  • deliver appropriate cost recovery of OTC medicines regulation.

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