Revised: 27 May 2013


Over-the-Counter (OTC) Medicines Business Process Reform Consultation Paper

Link to consultation document " Over-the-Counter (OTC) Medicines Business Process Reform in PDF (PDF document 1411 KB)

Invitation to comment

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


Document released for consultation on Thursday 13th September 2012

Interested parties should respond by close of business Wednesday 7th 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.

Information on how to make a submission

Detailed information on how to make a submission, and who to contact for further information about the proposed reforms, is detailed within the body of the consultation paper.

Your submission should include:

  • your name and full contact details including: address, telephone number, email and if applicable facsimile
  • the particular issue being addressed
  • relevant evidence and/or examples to support the views expressed
  • in the case of organisations, the level at which the submission was authorised.

Please note: Submissions should be confined to the specific subject matter of this consultation paper. Any submissions received that do not directly relate to the subject area, or that reference other consultation papers, will not be considered.

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.

Address for submissions

  • Electronic submissions should be e-mailed to:
    with OTC BPR in the subject heading.
  • Hardcopy submissions should be mailed to one of the following addresses :

    Manager Product Regulation
    Medsafe, Ministry of Health
    PO Box 5013

    OTC Medicines Regulatory Process Review
    Therapeutic Goods Administration
    PO Box 100
    WODEN ACT 2606

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 is: 7th 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 Medsafe website and the Therapeutic Goods Administration website at as soon as possible. Implementation of the changes is expected to commence in both countries by the end of April 2013.


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