New standard for serialisation and data matrix codes on medicines

The Therapeutic Goods Administration (TGA) has introduced a new standard for serialisation of medicines and use of data matrix codes. Therapeutic Goods (Medicines - Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021, commences on 1 January 2023 and provides clarity for adopters of serialisation and data matrix codes on medicines supplied in Australia.

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

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:

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

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

See also: Serialisation and data matrix codes on medicines.

The standard and guidance incorporate feedback received during consultation. Thank you to everyone who provided feedback and helped with development of the standard.