Standard for serialisation and data matrix codes commences 1 January 2023

Find out about the requirements starting on 1 January 2023 for medicines supplied in Australia that are serialised or include a data matrix code.

Medicine sponsors and manufacturers need to be ready

Therapeutic Goods (Medicines-Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 commences on 1 January 2023.

If you include data matrix codes or serialisation on your medicines, you need to be ready for the requirements set out in TGO 106.

Requirements for medicines with data matrix codes or serialisation

TGO 106 does not mandate the use of data matrix codes or serialisation of medicines but sets out requirements if medicine sponsors choose to do either of these.

Medicines released from supply from 1 January 2023 must comply with the requirements of TGO 106 if they do any of the following:

• are serialised
• include a data matrix code that encodes a Global Trade Item Number (GTIN).

For these medicines, a data matrix code must be formatted as a GS1 DataMatrix, as set out in the GS1 General Specifications. TGO 106 also sets out specific requirements including:

• how human readable information must be formatted on the primary pack
• that information in a DataMatrix must be consistent with all machine-readable and human-readable information on the label, and any relevant content of the Product Information (PI) or Consumer Medicine Information (CMI).

Guidance for TGO 106

Guidance is available that clarifies the requirements of the standard, including readability and the need to include consistent GTINs if multiple machine-readable codes are present.

Alignment with international standards

TGO 106 was introduced in 2021 to give clarity for adopters of serialisation and data matrix codes on medicines supplied in Australia.

TGO 106 aligns with global standards to give consistency for sponsors and manufacturers operating in multiple jurisdictions and to allow international interoperability.

Both the standard and guidance were developed with stakeholder input and incorporated feedback received during consultation.