Vapes: information for sponsors, importers and manufacturers

This page provides an overview of what businesses involved in the importation and manufacture of therapeutic 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 devices, vaping accessories, and vaping substances.

Cannabis vapes are subject to different requirements. Read more about these requirements on the Medicinal cannabis hub.

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.

Read more about Vapes: information for wholesale, transport, logistics and storage facilities.

Vapes are unapproved goods

There are currently no vapes for smoking cessation or the management of nicotine dependence included in the Australian Register of Therapeutic Goods (ARTG).

No vapes have been assessed by the TGA for quality, safety and efficacy or performance.

Therapeutic goods that are not included in the ARTG are known as unregistered or unapproved therapeutic goods.

Importing vapes into Australia

How to import

The importation of vapes is subject to the Customs (Prohibited Imports) Regulations 1956.

Importers must:

• hold an import licence and a permit to import issued by the Office of Drug Control (ODC).  Read more about Importing vaping goods into Australia
• notify the TGA of compliance with relevant product standards
• comply with the import clearance requirements outlined on the Australian Border Force (ABF) website

Licence to import vapes

• A licence is required before importing  vapes.
• To obtain an import licence, the importer must have an Australian Business Number (ABN) and be registered for the Goods and Services Tax (GST).
• The importer must hold any relevant licence or approval required under state and territory laws for supplying vapes, including for nicotine products as relevant.

Permit to import vapes

• Importers must either hold or obtain a licence to import vapes before applying for a permit to import.
• A permit to import is required for each specific type of vape, i.e. vaping devices, vaping accessories, and vaping substances.
• Importers must have notified the TGA declaring that the vapes comply with relevant product standards (see below), unless the goods are included in the ARTG.
• Read more about making pre-market notifications in the TGA guidance for sponsor notice – vaping goods

What can be imported

• Vapes that have been notified to comply with applicable standards for supply in Australia and are only indicated for smoking cessation or the management of nicotine dependence.
• Unapproved therapeutic vaping goods for the purpose of clinical trials or other kinds of medical or scientific testing may be imported only if the importer holds or obtains a licence and permit. Once imported, unapproved therapeutic vapes can be supplied by vape sponsors and clinical trial sponsors for the purpose of clinical trials in accordance with the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme . Sponsors of unapproved therapeutic vapes and clinical trial sponsors require consent from the TGA before possessing or supplying unapproved therapeutic goods. A pathway to apply for consent will be made available in the near future.

What cannot be imported

• Vapes cannot be imported without an import licence and permit.
• 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 or other exceptions apply.

Manufacturing vapes in Australia

Manufacturers of unapproved vaping substances, or packs containing a vaping substance and devices, for smoking cessation and the management of nicotine dependence must:

• obtain a manufacturing licence from the TGA, unless a relevant exemption applies
• ensure manufacturing processes comply with the principles of Good Manufacturing Practice (GMP)
• keep and retain records relating to the procedures, materials, tests and other elements used in the manufacture of the goods
• ensure goods comply with product standards for therapeutic vaping substances and devices
• provide pre-market notifications to the TGA declaring compliance with the relevant product standards, prior to the supply of those goods

GMP exemption

Australian manufacturers that were manufacturing non-nicotine vapes on or before 2 May 2023 may be eligible for an exemption from GMP requirements for the period between 1 January 2024 and 1 December 2024.

Read more about making a Notification to carry out steps in the manufacture of therapeutic vaping goods. A pathway to apply for consent will be made available in the near future.

Read more on the Responsibilities of manufacturers of medicines and biologicals.

Meeting product standards

Product standards apply to all unapproved vaping goods lawfully available in Australia for smoking cessation or the management of nicotine dependence. This includes vaping substances, vaping substance accessories, vaping devices and vaping device accessories.

To be lawfully supplied in Australia, unapproved therapeutic vapes for smoking cessation or the management of nicotine dependence must comply with the:

• Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110)
• Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order (MDSO)

The MDSO applies to therapeutic vaping devices and accessories whilst the TGO applies to therapeutic vaping substance and vaping substance accessories.

These standards are being strengthened and include new requirements for devices, ingredients, packaging and labelling. The strengthened standards will be implemented in stages during the first half of 2025.

Read more about the product standards .

Notification of compliance

Importers, manufacturers and sponsors must notify the TGA of compliance with the standards that apply to vaping substances and to vaping devices through a sponsor notice prior to importing or supplying the product.

Importers or sponsors are required to submit a sponsor notice form to declare that vapes:

• comply with applicable standards
• are only indicated for smoking cessation or the management of nicotine dependence.

A notice form must be submitted for each separate and distinct vaping good, substance or device type.

A sponsor notice must be given for:

• therapeutic vapes that are finished goods, and
• ingredients or components that are imported or supplied for use in the further manufacture of therapeutic vapes in Australia.

A form must only be submitted once in relation to each type of therapeutic vape, it is not required before each importation or release for supply of the same type of good.

The notice form(s) must be submitted through the TGA Business Services.

The TGA maintains a list of vapes (including vaping substances, vaping accessories and vaping devices) that have been notified as complying with applicable standards for supply in Australia: List of notified vapes.

A sponsor notice must be submitted before importing a therapeutic vape into Australia.

Vapes that do not comply with applicable standards, or with indications other than smoking cessation or the management of nicotine dependence, cannot be imported or supplied.

A sponsor notice is not required for therapeutic vapes included in the ARTG.

Read TGA’s Guidance for Sponsor notice – Vaping goods (Notice to import or supply in Australia therapeutic vaping goods) form.

Additional requirements for sponsors

From 1 July 2024, sponsors (often the manufacturer or importer) will also be required to:

• provide a reasonable number of samples of therapeutic vapes to the TGA, when requested and within the period requested (at least 5 working days)
• allow an authorised officer to enter and inspect premises when requested, including taking photos, video, require tests to be conducted or take samples of therapeutic vapes from the premises
• provide documents relating to the therapeutic vapes to authorised officers on request and allow copying of such documents
• if not the manufacturer, have procedures in place to ensure that, when requested, the manufacturer produces documents relating to the therapeutic vapes and allows the documents to be copied.

Existing requirements under the regulatory framework for therapeutic vapes, such as reporting and record-keeping, continue to apply (see below).

Supply reporting requirements

Importers, manufacturers and sponsors of unapproved therapeutic vapes have reporting requirements. Reports must:

• outline the quantities, brand and nicotine concentration of each kind of therapeutic vape the sponsor supplied in Australia under the Special Access and Authorised Prescriber  Schemes
• be submitted every 6 months
• be submitted within 1 month of the end of the relevant reporting period.
• be provided by email to SAS.Support@health.gov.au.
• be prepared for the reporting periods 1 January - 30 June (inclusive) and 1 July - 31 December (inclusive).

Read more on the Sponsor six monthly reporting form webpage and Guidance on TGO 110.

Applying for registration on the ARTG

To apply for ARTG registration for a therapeutic vaping substance a sponsor must lodge a submission to register a prescription medicine. This consists of:

• data that supports the quality, safety and efficacy of the product for its intended use
• completed forms, and
• the payment of fees.

Therapeutic vapes will be expected to comply with all applicable default standards, including, any applicable monograph(s) in the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopoeia-National Formulary, and any relevant ministerial standards (known as 'Therapeutic Goods Orders').

Therapeutic vaping devices and therapeutic vaping device accessories may be included in the ARTG under the medical devices framework (Chapter 4 of the Therapeutic Goods Act 1989) if they meet the regulatory requirements for a medical device and have appropriate evidence to support ARTG inclusion.

Read more about the Medical device inclusion process.

Potential sponsors are encouraged to have a pre-submission meeting with the TGA before making a TGA Conformity Assessment Certification application.

Read more on registering prescription medicines in the ARTG on our Prescription medicines hub and Supply a medical device page.

Wholesale, disposal and export of 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.

From 1 July 2024, it is unlawful to import, manufacture, supply or possess for commercial purposes any vapes that do not meet the requirements under the Therapeutic Goods Act 1989.

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.

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.

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

Using storage and transportation services to facilitate supply, export or disposal

Commercial entities may engage authorised storage or transportation services to facilitate lawful supply, export or disposal or vapes.

Further information about the requirements for transport and storage operators is available here: Vapes: information for wholesale, transport, logistics and storage facilities.

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.

Report side effects and problems

The TGA has an important role in monitoring the safety of unapproved goods.

We encourage you to report any suspected side effects relating to therapeutic vapes: Report an adverse event or problem (industry).

Related links / legislation

Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024
Customs (Prohibited Imports) Regulations 1956 (PI Regulations).  
Public Health (Tobacco and Other Products) Act 2023