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

13 March 2013


Business process reforms for over-the-counter medicines are being undertaken in order to improve the current system, and to develop a common approach by Australia and New Zealand. The development of these improvements has been undertaken with the support of an OTC industry working group, the objectives being to:

  • Deliver a more efficient and cost-effective process for industry in Australia and New Zealand.
  • Provide greater transparency and predictability of the regulatory process for sponsors.
  • Improve the quality of OTC medicine applications lodged with TGA and Medsafe.
  • Ensure an appropriate benefit/risk model is used for market authorisation of OTC medicines.

Outcome and submissions from the OTC business process reform consultation paper

A consultation paper on the OTC medicines business process reform was issued for public comment on 17 September 2012. The response to the submissions to the consultation is available on the TGA and Medsafe websites. This details the considerations given to the submissions detailing the considerations given to the submissions and outlines the amendments made to the process described in the consultation paper.


On 15 April 2013, Medsafe and the TGA will start the introduction of new administrative procedures for the processing of new and changed OTC medicine applications. These changes will improve the regulatory processes for those who wish to supply OTC medicines in either Australia or New Zealand.

A twelve month period of phased implementation, will commence on 15 April 2013, to allow applicants to become used to the new processes.

Next steps

In the week beginning 18 March 2013, TGA and Medsafe intend to release on their websites new detailed guidance documents on the application and evaluation process and accompanying information about the changes.

These documents are being released so that industry has the opportunity to prepare for the upcoming changes.

During the implementation phase this guidance documentation will be updated in response to feedback. Details of how to provide feedback will be made available on the respective websites.

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