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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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Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine—Pfizer) (SARS-CoV-2 Spike Protein (mRNA) XFG) Labelling Exemption 2026
This instrument is made under section 39 of the current Poisons Standard. -
Updates to the Prescribing Medicines in Pregnancy database - October 2026
The Prescription Medicines in Pregnancy database has been updated to include new entries and amend some existing entries. -
TGA seeks public views on stronger vitamin B6 labelling for low-risk medicines
We seeking feedback on a proposal to strengthen the labelling of low-risk products that contain vitamin B6.
Latest publications
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Regulation impact statement: General requirements for labels for medicines
Open consultations
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Consultation: 2026-2027 Proposed changes to the Permissible Ingredients Determination - Low-negligible risk
We're seeking feedback on proposed changes to the requirements of ingredients used in listed (low-risk) medicines. Myristica fragrans use during pregnancy and lactation and requirements relating to amygdalin and hydrocyanic acid.
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Consultation: High-moderate risk changes to permissible ingredients - Vitamin B6 (pyridoxine hydrochloride, pyridoxal 5-phosphate, and pyridoxal 5-phosphate monohydrate)
The Therapeutic Goods Administration (TGA) is seeking public comment on proposed changes to the Therapeutic Goods (Permissible Ingredients) Determination relating to listed medicines containing vitamin B6, namely pyridoxine hydrochloride, pyridoxal 5-phosphate and pyridoxal 5-phosphate monohydrate.