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

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.

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 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.