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Standards for labels and packaging
Standards for labels and packaging of medicines and biologicals.
TGO 91 and TGO 92 are registered on the Federal Register of Legislation and a guidance document is available to assist you in complying with the requirements.
These Orders came into effect on 31 August 2016, which started a four year transition period.
The transition period ended on 31 August 2020. All affected medicines released for supply from 1 September 2020 must comply with the labelling requirements of TGO 91 or 92.
Leftover stock in warehouses can still be supplied as long as it was released before 1 September 2020. This stock should be minimal as the four year transition period has allowed time for sponsors to update labels and release existing stock.
There is also a standard for biologicals - TGO 107: Standard for Biologicals - Labelling Requirements.
Guidance and resources
- GuidanceThis guidance is for manufacturers, sponsors and providers of biologicals and human cell and tissue (HCT) materials.
- Section 14/14A application form relating to subsection 9(2) of TGO 92
- New standard for serialisation and data matrix codes on medicines
- Standard for serialisation and data matrix codes on medicines
- Medicine labels: Guidance on TGO 91 and TGO 92
- Child-resistant packaging requirements for medicines - Guidance on TGO 95