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Vapes: information for sponsors, importers and manufacturers

Learn what the regulatory changes mean for the importation and manufacture of therapeutic vapes.

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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:

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, unless the consent of the Secretary is obtained (read more below), unapproved therapeutic vapes for smoking cessation or the management of nicotine dependence must comply with the:

Read more about the product standards.

Notification of compliance

Sponsors must notify the TGA of compliance through a sponsor notice prior to importing or supplying the product.

Sponsors are required to submit a sponsor notice form to declare that the vapes:

  • comply with applicable product standards (or are being imported or supplied with the written consent of the Secretary)
  • 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 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: List of notified vapes.

A sponsor notice must be submitted before importing or supplying a therapeutic vape (or an ingredient, component or article for use in the manufacture of a therapeutic vape). For importation, the notice must be submitted before applying to the Office of Drug Control for a permission to import the goods: Importing vaping goods into Australia.

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.

Consent to supply therapeutic vapes that do not meet applicable product standards

It is an offence to import, supply or export therapeutic vaping goods that do not comply with applicable product standards, unless the prior consent in writing of the Secretary has been given under:

  • section 14 or 14A of the Therapeutic Goods Act 1989, in respect of non-compliance with TGO 110; or
  • section 41MA or 41MAA of the Act, in respect of non-compliance with the essential principles (including where the goods do not comply with the MDSO or every principle contained in Schedule 1 to the Medical Devices Regulations).

Sponsors of therapeutic vaping goods may seek consent to import or supply therapeutic vaping goods that do not meet the applicable standards and/or essential principles. Applicants should be aware of the following:

No legislated timeframe for decision-making

The TGA does not operate under a legislated timeframe to assess applications for consent to import or supply therapeutic vaping goods that do not meet applicable standards or the essential principles. 

Applying necessary regulatory caution

Sections 14, 14A, 41MA and 41MAA of the Act protect the health and safety of patients and the broader public by prohibiting the importation, exportation and supply of therapeutic goods which do not conform with an applicable standard or the essential principles, being minimum product standards concerning the safety, quality, efficacy and/or performance of applicable goods.

However, the consent powers may be used to help facilitate the timely availability of those goods, despite non-compliance with applicable standards or the essential principles, on a case-by-case basis.

The TGA will carefully consider whether importation or supply of the therapeutic vaping goods is appropriate in all the circumstances, despite non-compliance with relevant product requirements.

The factors that the TGA delegate may take into account for this purpose include:

  • whether the nature of the non-compliance, and the risks associated with that non-compliance, are appropriately understood and explained by the sponsor (including by reference to the specific provisions of the applicable standards or the essential principles in relation to which a consent is sought);
  • clinical need for an uninterrupted supply and extent to which suitable alternatives are available;
  • the extent to which the imposition of appropriate conditions will sufficiently mitigate any risks;
  • whether it is appropriate to limit the scope of the consent, including by reference to duration of the consent, the goods the subject of the consent (e.g. the number of batches) or the consent being in relation to only import or supply (rather than both);
  • whether the issue giving rise to the non-compliance was foreseeable or avoidable.

Consent to import or supply is not guaranteed

Sponsors should not assume that consent to import or supply will be granted. Each application is assessed on a case-by-case basis. Allowing importation or supply of products that do not meet the required standards will only be consented by the TGA where considered appropriate.

Addressing the above matters, as well all other issues relevant to the particular application, will assist the TGA in dealing with an application in a timely manner as it avoids a delegate needing to, for example, delay their consideration of the application until further information has been provided by the sponsor.

Read more about Consent to import, supply or export therapeutic goods that do not comply with standards and Consent for medical devices that do not meet the Essential Principles.

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:

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
 

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