Towards a National Medicines Traceability Framework (NMTF)

Closed 28 Feb 2022

Opened 29 Nov 2021

Feedback updated 2 Sep 2022

We asked

Between November 2021 and March 2022, the Department of Health and Aged Care conducted initial targeted consultations with the medicines sector about the potential to introduce a National Medicines Traceability Framework in Australia.

This initial round of consultation sought to:

  • help shape the framework policy
  • determine feasible framework designs and implementation approaches
  • gauge industry’s appetite and readiness to operation within a framework
  • identify the expected impacts and benefits a framework may have on businesses.

You said

We received 42 submissions from a cross section of stakeholders, including medicines sponsors, wholesalers, peak bodies (including consumer and clinical representatives), pharmacies, and state and territory organisations.

We did

We have reviewed all submissions and the results are now available in the NMTF - Analysis of Consultation Survey Responses. Note, the questions that relate to each section of analysis are summarised in the report at the end of each page.

The results show:

  • the type of NMTF will determine the benefits that can be realised, for example, while 79 per cent of respondents proposed that an NMTF could provide faster and more accurate product recalls, this is likely to refer to a full track and trace model, rather than ‘point of dispense’ model
  • organisations expect additional investment in data systems and services, with some planning and implementation assistance likely to be needed
  • organisations expect a high regulatory burden, noting this is dependent on the type of NMTF to be implemented i.e. full track and trace, point of dispense verification, or a dispersed data model
  • organisations are confident they could participate in an NMTF, however, there is a clear need for further detailed stakeholder engagement on the function and scope of an NMTF.

In addition to these results, there are a range of other issues that require further detailed consultation, for example, impacts on patient privacy, data security, and the appropriate role of governments.

We will continue to consult with stakeholders as the NMTF policy recommendations are further developed. More opportunities for wider consultation on key elements of the framework will be available at a later date.


The purpose of this consultation is to seek initial input from medicine supply chain industry stakeholders about a National Medicines Traceability Framework (NMTF). This activity follows international developments in medicine track and trace systems, and the 2020-21 Budget measure: Improving Access to Medicines – development of Unique Identification framework for PBS medicines.

The Department’s NMTF Consultation Paper highlights the rationale and contemporary approaches to the design and potential benefits of a national medicines traceability framework and provides references, further reading, and glossary. No specific framework design or timeframe for implementation has yet been decided, as the measure is currently in the initial consultation stage.

Our consultation is focused on key industry stakeholders participating across the medicine supply chain, from medicine manufacture through to pharmacy dispensing. There will be further opportunity for consultation with a wider group of stakeholders as the NMTF is progressed. The results of the consultation will inform possible recommendations to Government and will ensure that your viewpoint has been considered.

The following references are particularly relevant in providing context for our current consultation:

Better healthcare: a vision for use of data matrix codes and medicines traceability, Therapeutic Goods Administration (TGA), July 2020

Standard for serialisation and data matrix codes on medicines: Guidance for Therapeutic Goods Order (TGO) 106, Therapeutic Goods Administration (TGA), March 2021

Recommendations on Common Technical Denominators for Track and Trace (T&T) Systems to Allow for Interoperability, International Coalition of Medicines Regulatory Authorities (ICMRA), August 2021

The World Health Organization Policy paper on traceability of medical products, 2021, World Health Organization (WHO), March 2021.

This survey is best completed on a desktop PC, laptop, or tablet.

What happens next

The NMTF consultation survey is now closed.

Submissions will be considered by the Department which will make recommendations to the Minister for Health based on, among other things, submissions received.

All submissions may be published by the Department where consent to do so has been provided by the respondent. 

Any inquiries regarding this consultation can be made to


  • State government agencies
  • Health professionals
  • Businesses
  • Prescription medicines


  • Hospitals
  • Pharmaceutical benefits
  • Regulatory policy
  • Prescription drugs