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.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageThis page contains a list of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards.
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PageLearn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.
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PageLearn about the regulatory framework for prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
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PageVapes cannot be supplied through any non-pharmacy retail store, such as tobacconists, vape shops or convenience stores in Australia.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.
Storage and handling
Access information about how the storage and handling of products is regulated.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.
Import and export
Access requirements for import and export of therapeutic goods.
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LegislationThe Customs (Prohibited Imports) (Vaping Goods) Approval 2023 establishes import control for vaping goods, including vapes, vape substances, and vape accessories.
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PageInformation for importers, exporters, and manufacturers about product quality, manufacturing standards, and reporting requirements.
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GuidanceFrom 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.
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PageLearn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.
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PageLearn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes.