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Consultation: Over-the-counter (OTC) medicines business process reform

Related information

17 September 2012

This consultation closed on 7 November 2012

Invitation to comment

Medsafe and the TGA sought comments from interested parties on proposed reforms to the business processes for the evaluation of over-the-counter (OTC) medicines.

Consultation documents

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Document released for consultation on Thursday 13 September 2012.

Interested parties responded by close of business Wednesday 7 November 2012.

Feedback will be released following consideration of submissions.


The Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) have been working on a review of the business processes for the evaluation of OTC medicines. The objectives of the reforms are to:

  • deliver more efficient and cost-effective processes
  • provide sponsors of OTC medicines with greater clarity, transparency and predictability
  • 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

About the consultation

This consultation paper outlines the key elements of the proposed business process reforms. The purpose is to seek feedback on the proposed reforms before proceeding with a detailed design of the new business processes, and development of associated documentation, such as regulatory guidelines.

Confidentiality of submissions

If you wish any information contained in your submission to be treated as confidential, please clearly identify that information and outline the reasons why you consider it to be confidential. Note that general disclaimers in covering emails will not be taken to be sufficient reason for submissions to be treated confidentially.

Questions relating to submissions

In Australia

Any questions relating to submissions should be directed to the OTC Medicines Business Process Reform, via email to

In New Zealand

Any questions relating to submissions should be directed to the Manager Product Regulation, via email to

Deadline for submissions

The deadline for receipt of submissions was 7 November 2012.

Next steps

The period for consultation on the proposed reforms to the business processes for OTC medicines has now closed. Analysis of submissions is currently being undertaken and the outcome of this will be advised on the website, the Medsafe website and the Therapeutic Goods Administration website as soon as possible. Implementation of the changes is expected to commence in both countries by the end of April 2013.

Submissions received

These are the submissions received by the TGA in response to the consultation paper.


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