The TGA, Australia has introduced a new standard for the serialisation of medicines and use of data matrix codes, effective from 2023.
The new standard is entitled Therapeutic Goods (Medicines—Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021.
What is the effective date for compliance with TGO 106 ?
Medicines released from supply from 1 January 2023 must comply with the requirements of TGO 106.
Which medicines are subject to TGO 106 requirements?
Medicines supplied in Australia are subject to TGO 106 requirements if they:
- are serialised
- include a data matrix code that encodes the Global Trade Item Number (GTIN).
What is the purpose of TGO 106?
TGO 106 sets out the requirements for medicines supplied in Australia that have to be compliant with the standard. It 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.
How does TGO 106 align with global standards?
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.
What does TGO 106 not set out?
TGO 106 does not set out any requirements regarding reporting, storage and verification of serialisation data.
About the guidance document that TGA has provided to accompany TGA 106
The 18 page guidance is for sponsors and manufacturers supplying medicines in Australia that have to be complaint with the TGO 106 standard. It includes information on how to comply with the standard.
Source: TGA website