Labelling and packaging
The regulation of medicines and medical devices extends to how they are labelled and packaged. The rules can be complex, depending on the product.
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Labelling and packaging
Regulatory information on the labelling and packaging of medicines and medical devices -
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Code of practice for tamper-evident packaging of therapeutic goods
A new version of the code of practice for tamper-evident packaging of therapeutic goods is now available. -
Labels for COVID-19 treatments
To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia. -
Labels for COVID-19 vaccines
To enable timely distribution of COVID-19 vaccines, international labels are being used during the initial global rollout, including in Australia. -
Australia's medicine labels are becoming clearer
2016 to 2020 transition arrangements for medicine labelling requirements.
Latest alerts
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Invacare Australia is updating the Instructions for Use (IFU) of the Birdie Lifter and Compact Lifter. Users need to be aware of the correct position for the carabiner and the correct attachment of the hanger bar.
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Takeda Pharmaceuticals Australia has issued a product alert for Vyvanse capsules due to minor packaging errors. The medication is safe to use as prescribed.
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If you've purchased APOHEALTH Paracetamol Pain Relief paracetamol 500 mg film-coated tablets in a bottle, ensure it is kept out of reach of children. This product does not have child-resistant packaging.
Latest articles
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TGA statement on sunscreen labelling practices
This statement provides guidance to industry about how the Therapeutic Goods Act 1989 applies in relation to sunscreen labelling. -
Changes to the Prescription Medicines Minor Variation (PMMV) form
We will implement process enhancements to the Prescription Medicines Minor Variation (PMMV) form by 31 January 2026. -
GMP Clearance: Update to the Sponsor Information Dashboard (SID)
The GMP Clearance SID now contains additional data as well as progress information on the Compliance Verification (CV) backlog reduction strategy.
Latest publications
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Regulation impact statement: General requirements for labels for medicines
Open consultations
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Consultation: Proposed changes to labelling of medicines supplied in Australia
We are seeking feedback on proposed changes to Australian medicine labelling rules.