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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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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. -
What do I need to do if my medicine or medical device is recalled?
Like all goods available in Australia, therapeutic goods can sometimes experience problems. When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. There are four types of market actions you should be aware of. -
More medicines begin transition to sole ingredient names soon
The dual labelling period for some medicine ingredients is ending on 30 April 2025.
Latest publications
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Regulation impact statement: General requirements for labels for medicines