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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
Learn about Australia’s requirements for labelling and packaging of therapeutic goods, including regulatory standards to ensure product safety, quality, and accurate information for consumers. -
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Code of practice for tamper-evident packaging of therapeutic goods
A code of practice for those involved in the design, selection and use of tamper-evident packaging. -
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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We are advising consumers that ‘Pharmatech’ branded MK-677 capsules (containing ibutamoren) may pose a serious risk to your health and should not be taken.
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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.
Latest articles
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Product Information safety updates - July 2026
Information for health professionals about medicines with safety related updates to their Product Information. -
Product Information safety updates - June 2026
Information for health professionals about medicines with safety related updates to their Product Information. -
Listed Medicine Compliance Reports - June 2026 update
We've updated the Listed Medicine Compliance Reports database with the results of compliance reviews covering 13 listed medicines.
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 Required Advisory Statements for Medicine Labels (RASML)
We are seeking feedback on proposed changes to the Required Advisory Statements for Medicine Labels (RASML).