The TGA has published a web page and requested industry associations to remind affected medicine sponsors and manufacturers to be prepared that the Therapeutic Goods (Medicines Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 will commence on 1 January 2023 following the transition period provided.
This instrument does not mandate the use of data matrix codes or serialisation of medicines, but sets out mandatory requirements if medicine sponsors choose to do either of these things.
Medicines, including listed complementary medicines, released from supply from 1 January 2023 must comply with the requirements of TGO 106 if they:
- are serialised (where each unit bears a unique identifier, allowing the unit to be identified distinctly within its batch); or
- include a data matrix code that encodes a Global Trade Item Number (GTIN).
For medicines that must comply with TGO 106, 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; and
- 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).
The guidance for TGO 106 clarifies the requirements of the standard, including readability and the need to include consistent GTINs if multiple machine-readable codes are present.
Background: The TGA introduced TGO 106 in 2021 to provide clarity for adopters of serialisation and data matrix codes on medicines supplied in Australia. TGO 106 aligns with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to enable international interoperability. The TGO 106 and the associated guidance has been developed by the TGA with stakeholder input and feedback received during consultation.
- Questions for TGA on the TGO 106 may be directed to TGA.Scientific@health.gov.au
- CMA may be contacted for industry issues at email@example.com
Prior CMA tech alert:
- CMA 29 march 2021 Tech alert: TGO 106 -New standard for medicines serialisation and data matrix code