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 30 Mar 2021

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 did

We considered all feedback received and made changes to the standard and guidance. We implemented the updated standard in March 2021. For more information, see new standard for serialisation and data matrix codes on medicines.

Changes we made in consideration of feedback included:

  • Extending the delayed commencement period to allow sufficient time for medicine manufacturers and sponsors already serialising medicines or using data matrix codes to comply with the standard. The standard now commences on 1 January 2023.
  • Reducing requirements to allow sponsors to use data matrix codes to identify medicines without a serial number where serialisation is not required. Medicines that are not serialised will not need to include additional data elements in a data matrix. These changes help to maintain benefits for scanning in health care settings where appropriate technology exists and assist those gradually implementing data matrix codes.
  • Restructuring the standard to streamline and clarify requirements for medicines that are serialised versus medicines that are not serialised but have a data matrix code that contains a GS1 Global Trade Item Number (GTIN).
  • Updating the guidance to clarify requirements for the primary pack and the information that needs to be included in a data matrix code. Primary pack is different to primary packaging, as explained in the guidance and new medicine packaging definitions for sponsors webpage.

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 your views matter

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