Consultation on the new Therapeutic Goods Order 106 - Data matrix codes and serialisation of medicines

Closed 20 Aug 2020

Opened 2 Jul 2020

Feedback Updated 29 Sep 2020

We Asked

We asked for feedback on our draft Therapeutic Goods Order 106 – Standard for Serialisation and Data Matrix Codes (TGO 106) because we want to make sure the standard is fit for purpose and provides clarity for early adopters of medicine serialisation and data matrix codes on medicines supplied in Australia.

You Said

We received 43 submissions in response to the consultation. Respondents provided a range of suggestions to improve the new Order and associated guidance, with many supporting the implementation of a standard to provide consistent regulatory requirements which align with international standards. We appreciate all the feedback we received.

We Did

We are currently reviewing all the submissions we received and will make changes to the draft Order and guidance in consideration of this feedback.

We plan to implement the updated standard before the end of the year. It is planned that the standard will have a delayed commencement period to allow sufficient time for medicine manufacturers and sponsors to comply with the standard.

Published Responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on proposed requirements for serialisation and the use of data matrix codes on the labels of certain medicines in the Australian supply chain.

To make sure the standard is clear, meaningful and fit for purpose. We are seeking feedback on its suitability and potential impacts.  

Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2020

Guidance for TGO 106 Medicines—Standard for Serialisation and Data Matrix Codes

Consultation paper

This consultation paper gives further details about data matrix codes and the standard.

Consultation paper - Data matrix codes and serialisation of medicines

Why We Are Consulting

Data matrix codes are an important first step towards a medicine traceability system. Better healthcare - a vision for the use of data matrix codes and medicines traceability explores the potential benefits for our Australian health care system.

What Happens Next

This consultation has now closed. Thank you to all who provided their feedback.

We will be reviewing and analysing all feedback received and updating the results on this page. Watch this space!

Audiences

  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • Health professionals
  • Community groups
  • Businesses
  • Aged care service providers
  • Health staff
  • HPRG (TGA) Staff
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Biogicals

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Legislation
  • Health insurance
  • Rural health services
  • Regulatory policy
  • Women's health
  • Children's health
  • Home Care
  • Aged Care
  • Residential Aged Care
  • Drugs and substance abuse
  • Immunisation
  • Prescription drugs
  • Preventative health
  • Dental health
  • Strategic Policy
  • Policy Development