Australia TGA Releases New Standard for Medicines with Data Matrix Codes or Serialisation

A new standard clarifying requirements for serialisation and data matrix codes on medicines supplied in Australia commences on 1 January 2023. The Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021 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. 

TGO 106 aligns with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability. 

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

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

The guidance for TGO 106 includes information on how to comply with the standard. 

More details are found on the Australia TGA website: 

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