We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
About therapeutic vaping goods
This information is for sponsors, importers, manufacturers and other parts of industry for therapeutic vaping goods. Information for consumers and health practitioners can be found at the Vaping hub. The vaping hub provides up-to-date information on the regulatory changes and how they impact the Australian community and health practitioners.
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.
Therapeutic vaping goods are unapproved therapeutic goods. This means they are not included in the Australian Register of Therapeutic Goods (ARTG). Unapproved therapeutic goods have not been assessed by us for safety, quality, performance or effectiveness.
Therapeutic vaping goods are only lawfully available for therapeutic purposes and for supply through pharmacies and pharmacy settings.
You must comply with regulations and obtain necessary approvals before supplying therapeutic vaping goods in Australia. The notified vape list specifies therapeutic vaping goods that may be prescribed and supplied for smoking cessation or the management of nicotine dependence in Australia.
We monitor safety and undertake compliance and enforcement activities to protect public health.
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.
