Australia: New Standard for Serialisation and Data Matrix Codes for medicines

 

In March 2021, a new standard, Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 was registered on the Federal Register of Legislation. The standard will commence on 1 January 2023.

TGO 106 does not mandate medicine serialisation or the application of data matrix codes to medicines, but sets out the technical requirements if the medicine sponsor implements either of these.

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

• are serialized
• include a data matrix code which encodes the Global Trade Item Number (GTIN).

TGO 106 defines the requirements for the presentation and content of data matrix codes including human readability requirements and relationship with other machine readable codes. The requirements include:

• Where a medicine is serialised this must be represented by a serial number encoded into a data matrix code that complies with the GS1 General Specifications for a DataMatrix.
• If a data matrix code containing a GTIN is applied to a unit of a medicine, this must be formatted as a GS1 DataMatrix that complies with the GS1 General Specifications.

TGO 106 does not set out any requirements regarding reporting, storage and verification of serialisation data.

The text of the standard is available HERE.

Moreover, a guidance for TGO 106 which includes information on how to comply with the standard is available under the following HERE.