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Recently updated
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Purpose
This guidance aims to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the labelling Orders.
Legislation
Guidance
This guidance is presented as a downloadable file because of its length.
Downloads
Page history
Update to include examples related:
- Medicine name on the main label
Minor update to information due to end of the transition period.
Additional information to provide clarity on:
- Transition period
- Declaration of benzoates
- Reference to the CMI for Schedule 1 declarable substances
- Multiple barcode guidance
Minor corrections based on stakeholder feedback.
Addition of information about warning statements for neuromuscular blocking agents in parts 1, 2 and 3.
Minor corrections based on stakeholder feedback.
Corrections based on feedback and clarification of existing information.
Addition of latex labelling in best practice – part 3.
Addition of guidance on determining when a Schedule 1 substance is present – part 1.
Original publication.
Update to include examples related:
- Medicine name on the main label
Minor update to information due to end of the transition period.
Additional information to provide clarity on:
- Transition period
- Declaration of benzoates
- Reference to the CMI for Schedule 1 declarable substances
- Multiple barcode guidance
Minor corrections based on stakeholder feedback.
Addition of information about warning statements for neuromuscular blocking agents in parts 1, 2 and 3.
Minor corrections based on stakeholder feedback.
Corrections based on feedback and clarification of existing information.
Addition of latex labelling in best practice – part 3.
Addition of guidance on determining when a Schedule 1 substance is present – part 1.
Original publication.