This page provides an overview of what businesses involved in the wholesale, transport, logistics, and storage of vapes need to know about the regulatory requirements for 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 substances, vaping accessories and vaping devices.
Cannabis vapes are subject to different requirements. Read more on the Medicinal cannabis hub.
Vaping laws restrict supply to pharmacies
From 1 July 2024, new regulations apply to all vapes, including vaping devices, irrespective of nicotine content or therapeutic claims. This means:
- only pharmacies (and health practitioners in certain circumstances) can lawfully supply vapes to consumers
- vapes can only be distributed to pharmacies through supply chains for prescription medicines and pharmacist only medicines.
- additional requirements apply for some businesses involved in the wholesale, transport, logistics, and storage of vapes
- only notified vapes can be lawfully imported, manufactured and supplied in Australia, unless an exception applies
- non-pharmacy retailers are not permitted to supply/sell any type of vape.
Requirements for importation
Existing laws still apply:
- An import licence from the Office of Drug Control (ODC) must be held by an importer.
- An import permit from ODC is required to import each specific type of vape, i.e. vaping devices, vaping accessories, and vaping substances.
- Import licences and permits will generally only be approved for vapes that meet new product standards and notification requirements under the Therapeutic Goods Act 1989 or are included in the Australian Register of Therapeutic Goods (ARTG).
- Other types of vapes, including vapes containing vitamins and melatonin, and heat not burn tobacco products are not eligible to obtain an import permit unless included in the ARTG.
Further information on importation is available here.
Requirements for wholesalers
Notified therapeutic vapes, including vaping devices and vaping substances that do not contain nicotine, may only be supplied by wholesalers who are either:
- licenced or authorised under state or territory laws to supply substances that are included in Schedule 4 to the Poisons Standard;
- the holder of a licence and permission to import vaping goods – see requirements for importation above; or
- the holder of a licence from the TGA to manufacture vaping goods, or the holder of a conformity assessment document that applies to the goods – see requirements for manufacture.
Wholesalers may only possess or supply vaping goods that are either included in the ARTG or are ‘notified vapes’ (see list of notified vapes at List of notified vapes).
Requirements for transport and logistics operators
Other lawful supply chain participants
Vapes, including vaping devices and vaping substances (whether or not they contain nicotine), can only be possessed and supplied by:
- a wholesaler, pharmacist, medical practitioner or nurse practitioner who is licenced, or is otherwise authorised, under a state or territory law to supply a Schedule 4 substance;
- the holder of a licence and permission to import vaping goods – see requirements for importation above; or
- the holder of a licence from the TGA to manufacture vaping goods, or those with conformity assessment documents applicable to vaping goods – see requirements for manufacture.
- transport operators, storage operators and waste operators, researchers and others with express permission by the TGA (i.e. under the Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024 made under section 41R of the Act).
Only pharmacists, medical practitioners and nurse practitioners are authorised to supply vapes directly to consumers.
Wholesalers, the holders of a licence and permission to import vaping goods, the holders of a licence to manufacture vaping goods and the holders of conformity assessment documents that apply to vaping goods may only supply vapes to the professionals listed above.
Temporary exceptions apply for:
- transport operators who are transporting vaping goods for export, disposal or into the lawful domestic supply chain;
- storage operators who are providing storage facilities for vaping goods to business operators who can lawfully possess those goods.
These temporary exceptions, as outlined in the section 41R instrument, are valid for to possession and supply activities occuring on or before 30 November 2024. Operators must comply with strict controls regarding who can provide vaping goods and to whom they can be delivered to. There are also security and record keeping requirements which must be followed for an exception to apply.
Regulatory arrangements for authorising transport and storage operators who are transporting or storing vaping goods after 30 November 2024 will be announced in the future.
Temporary exceptions also apply for manufacturers, importers, exporters, wholesalers, retailers, waste storage operators, researchers and individuals. See the section 41R instrument and related guidance for further details.
Only vaping goods that are either included in the ARTG or are ‘notified vapes’ (see list of notified vapes at List of notified vapes) may be possessed or supplied.
More information:
List of notified vapes
The TGA maintains a list of vapes (including vaping substances, vaping accessories and vaping devices) that have been notified as complying with the product standards.
This list can be used to identify the vapes that can be legally imported, manufactured and supplied in Australia, subject to relevant requirements being met.
Read more on the list of notified vapes.
Disposal and export of unlawful vapes
Since the Australian Government first announced its intention to regulate the supply of vapes on 2 May 2023, sponsors, manufacturers, and non-pharmacy retailers have been encouraged to run down their stocks before the changes took effect.
It has been unlawful to import, manufacture, supply or possess for commercial purposes any vapes that do not meet the requirements under the Therapeutic Goods Act 1989 since 1 July 2024.
The commercial possession restrictions prohibit:
- any person possessing a commercial quantity or more of vapes (currently 9 vaping devices, 60 vaping accessories or 400mL of liquid vaping substance), or
- a retailer possessing any vapes on retail premises,
subject to limited exceptions for personal use and persons involved in the legitimate pharmacy supply chain.
Individuals, including retail workers, should refer to the information page for patients and consumers for information about how many vapes they can possess and in what circumstances. Suppliers, manufacturers, wholesalers, importers and exporters should refer to Vapes: information for sponsors, importers and manufacturers.
The maximum penalties that will apply are up to 7 years in jail per offence and/or up to $2.191 million per contravention for an individual and $21.91 million per contravention for a corporation.
Subject to strict conditions, wholesalers, transport and logistic operators and storage providers may be able to:
- export;
- supply to pharmacies or authorised persons in the supply chain; or
- surrender to the TGA or a waste disposal facility;
vaping goods which were lawfully imported or manufactured, and obtained by them, before 1 July 2024.
These export, supply and disposal pathways are explained on Vapes: information for sponsors, importers and manufacturers.
Wholesalers, transport and logistic operators and storage providers should review this material as soon as practicable, as these pathways are subject to strict timing and other requirements. Failure to comply with requirements may mean that a wholesaler, operator or storage provider is in unlawful possession of vapes, which may result in significant penalties or a term of imprisonment.
Possession and supply exceptions
The Therapeutic Goods (Vaping Goods – Possession and Supply) Determination 2024 (the Determination) provides exceptions for businesses and individuals to possess and supply vaping goods in certain circumstances without being in breach of relevant offences or civil penalty provisions.
Under the Determination, additional time is available for the:
- surrender of unlawful vaping goods through the TGA business surrender scheme (notification period closed 1 September 2024).
- transport, storage or disposal of vapes in certain circumstances,
- export of unlawful vapes in certain circumstances, and
- other limited activities.
These transitional arrangements will operate for a limited period and require certain actions to be taken and strict conditions to be met to qualify for the exception. Where a person is relying upon an exception in the Determination for their possession or supply of vaping goods, credible evidence must be retained to demonstrate compliance with the relevant requirements and conditions.
More information:
- Business surrender scheme underway, notification period ends
- Possession and supply of vaping goods in Australia: Guidance on the legal instrument: Therapeutic Goods (Vaping Goods—Possession and Supply) Determination 2024
Restrictions on advertising and promotion of vapes
Changes to the Therapeutic Goods Act 1989 from 1 July 2024 prohibit advertising of all vaping goods unless authorised by the TGA. There are significant penalties for advertising vaping goods without authorisation.
Read more about advertising and promotion requirements.
New offences and civil penalties
There are also new offences and civil penalties for people who do not comply. This includes penalties for unlawful importation, domestic manufacture, supply, commercial possession and advertisement.
If you suspect illegal import, manufacture, supply, commercial possession or advertising of vapes and vaping goods, please report a breach to the TGA.