Standard for serialisation and data matrix codes on medicines v1.0

This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in the Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021. The purpose of TGO 106 is to provide clarity for adopters of serialisation and data matrix codes on medicines supplied in Australia. It is the first step in establishing requirements that support all systems relying on the codes. Where possible, TGO 106 requirements align with global standards to provide consistency for sponsors and manufacturers operating in multiple jurisdictions and to ensure global interoperability.

Main sections:

· About this guidance

· About TGO 106

· Medicines that are subject to TGO 106 requirements

· Medicines that are exempt from TGO 106

· Machine-readable codes

· Serialised medicines

· Relevant level of packaging

· Requirements of TGO 106