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You must comply with regulatory requirements when manufacturing, supplying, or distributing therapeutic vapes.
The Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 (the Act) commenced on 1 July 2024. The legislation introduced a single consistent framework that applies nationally to regulate the importation, domestic manufacture, supply, commercial possession and advertisement of all vapes.
Vapes include vaping devices, vaping accessories, and vaping substances.
Note: from 1 October 2024, therapeutic vapes are available for supply in pharmacy settings to patients 18 years or over without a prescription, subject to state and territory laws and certain conditions being met, including a maximum nicotine concentration of 20mg/mL.
Vapes are only lawfully available for therapeutic purposes and for supply through pharmacies and pharmacy settings.
The Office of Drug Control - as part of the Australian Government Department of Health, Disability and Ageing, regulates and provides advice on the import of therapeutic vaping goods.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all unapproved therapeutic goods and all products.