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Vapes: information for importers, manufacturers and wholesalers
How Australian sponsors can import, manufacture and supply vapes for smoking cessation or the management of nicotine dependence. This page also includes information on how wholesalers can supply vapes to Australian pharmacies.
This guidance does not apply to cannabis vapes, which are subject to separate strict regulation. Find out more at the Medicinal cannabis hub.
This page provides an overview of how Australian sponsors can import, manufacture and supply therapeutic vapes for smoking cessation or the management of nicotine dependence, and how wholesalers can supply these vapes to Australian pharmacies.
Reforms to the regulation of vapes
New regulations to place stronger controls on the importation, manufacture, and supply of vapes have now been made and are being implemented in stages in 2024. The first stage is the introduction of stricter import controls on vapes from 1 January 2024, with further controls to commence on 1 March 2024.
These reforms will protect Australians, particularly young people, from the harms of vaping and nicotine dependence while ensuring vapes remain available from a pharmacy to patients with a prescription, where clinically appropriate.
From 1 January 2024, the importation of all disposable vapes is banned, subject to very limited exceptions. This means that importers cannot import any disposable vapes from overseas.
Disposable vapes that were imported into Australia before 1 January 2024 may continue to be lawfully supplied in Australia subject to the following requirements:
- disposable vapes containing nicotine that meet TGA requirements (including the quality requirements under the existing product standard) may continue to be lawfully supplied in Australia in pharmacy settings to a patient with a prescription in accordance with state and territory laws for prescription medicines
- disposable vapes that do not contain nicotine, or any other medicine, and do not make therapeutic claims, may be supplied by retailers generally, including vape stores, subject to state or territory law.
This allows legitimate retailers of disposable vapes to run down their stocks prior to the Government introducing legislation in early 2024 to prevent the domestic manufacture, advertisement, supply and commercial possession of disposable vapes to ensure comprehensive controls across all levels of the supply chain.
- importers will generally only be eligible to obtain a permit to import vapes if those vapes are included in the ARTG or meet new notification requirements under the Therapeutic Goods Act 1989.
- new exemptions under the Therapeutic Goods Act 1989 outlining the new notification requirements will apply to unregistered or ‘unapproved’ vapes for smoking cessation or the management of nicotine dependence.
- other types of vapes, including vapes containing vitamins and melatonin, and heat not burn tobacco products will not be eligible to obtain an import permit unless included in the Australian Register of Therapeutic Goods or other exceptions apply under the customs legislation.
Reusable vapes that have been imported into Australia or manufactured in Australia before 1 March 2024 may continue to be lawfully supplied in Australia subject to the following requirements:
- reusable vapes containing nicotine that meet TGA requirements (including the quality requirements under the existing product standard) can continue to be lawfully supplied in Australia in pharmacy settings to patients with prescriptions in accordance with state and territory laws for prescription medicines,
- reusable vapes that do not contain nicotine, or any other medicine, and do not make therapeutic claims, can continue to be supplied by retailers generally, including vape stores, subject to state or territory law.
This will allow legitimate retailers of reusable vapes to run down their stocks prior to the Government introducing legislation in early 2024 to prevent the domestic manufacture, advertisement, supply and commercial possession of non-therapeutic vapes to ensure comprehensive controls across all levels of the supply chain. The new notification pathway only applies to vapes imported into Australia or manufactured in Australia after 1 March 2024.
Vapes are unapproved goods
Generally, therapeutic goods must be evaluated by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, or supplied in, Australia.
There are currently no vapes for smoking cessation or the management of nicotine dependence that have been evaluated by the TGA and included in the ARTG. Therapeutic goods that are not included in the ARTG are known as unregistered or ‘unapproved’ therapeutic goods. These goods have not been assessed by the TGA for quality, safety and efficacy or performance.
Product standard for unapproved vapes
The updated standard for vapes, the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) commenced on 1 January 2024. It includes minor updates to requirements that will apply to goods that are imported or manufactured from 1 March 2024. The standard was previously known as the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021.
The requirements in TGO 110 apply to therapeutic vaping goods that are indicated for smoking cessation or the management of nicotine dependence. The requirements apply to therapeutic vaping substances (including filled pods and cartridges) and packs that contain a combination of vaping goods (including therapeutic vaping devices and unfilled pods and cartridges).
TGO 110 includes requirements about:
- product labelling (including an oversticker or in an information sheet provided with the product)
- child resistant packaging
- maximum nicotine concentration (although people can only access the nicotine concentration prescribed to them)
- requiring actual nicotine concentration/content of the vape to reflect the product label
- prohibited ingredients
- accepted flavours of mint, menthol and tobacco
- quality management system requirements for vaping devices and vaping device accessories
- documentation that needs to be kept by the Australian sponsor of the product.
Australian sponsors of unapproved vapes must keep documentation demonstrating compliance with the requirements of TGO 110.
Further information on the updated requirements in TGO 110 is available here: Guidance for Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).
Therapeutic vaping substances are not required to comply with monograph(s) in the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopeia-National Formulary that apply to those products as default standards.
Therapeutic vaping substances must comply with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018.
The ‘Contaminants and product quality’ section of our current Guidance on TGO 110 provides further information for Australian sponsors (importers and manufacturers) regarding product quality and potentially harmful contaminants that may be present in vapes and/or their aerosols.
Importing unapproved vapes
From 1 March 2024, importers will be required to:
- provide pre-market notifications to the TGA declaring compliance with the relevant product standards (e.g. TGO 110), prior to the importation or supply of those goods; and
- hold an import licence, and permit in relation to the goods, from the Office of Drug Control (ODC).
Information about making pre-market notifications can be found here.
Information about how to obtain import licences and permits, including application forms and instructions, is available on the ODC website here.
Australia has import clearance requirements for all goods. Importers and sponsors should refer to the Australian Border Force (ABF) Website for information on the required declarations to clear imported goods from customs control.
The Australian sponsor (importer or manufacturer) can import and supply or manufacture and supply unapproved vapes (as the case may be) for smoking cessation or the management of nicotine dependence before pharmacies receive a prescription under the Authorised Prescriber (AP) scheme or Special Access Schemes. Similarly, pharmacies may stock unapproved vapes for smoking cessation or the management of nicotine dependence in their dispensaries for the purpose of dispensing, prior to the receipt of prescriptions.
Unapproved therapeutic vapes may continue to be imported, manufactured, and supplied for the purpose of clinical trials conducted under the Clinical Trial Notification (CTN) scheme in accordance with the usual requirements for that scheme, even after the new requirements commence.
Manufacturing unapproved vapes for smoking cessation or the management of nicotine dependence
Australian manufacturers of unapproved vapes for smoking cessation and the management of nicotine dependence must obtain a GMP licence from the TGA, unless a relevant exemption applies.
Australian manufacturers who were manufacturing non-nicotine vapes on 2 May 2023 may be eligible for a temporary exemption from GMP requirements.
Applications for a temporary exemption can be made using the form for transitional manufacturers. Manufacturers should contact the TGA for further information about the temporary exemption and making an application.
A GMP licence is not required to manufacture unapproved vapes at manufacturing sites outside Australia. GMP clearance is also not required where unapproved vapes are manufactured overseas and imported into Australia via the AP, SAS B, SAS C, or as part of a clinical trial. However, the Australian sponsor of the product will need to ensure that it meets the requisite standards for importation and supply in Australia. In particular, the sponsor will need to maintain records demonstrating that the product conforms to the requirements of TGO 110. However, consideration is being given to introducing a requirement for GMP for all therapeutic vaping substances as part of the proposed changes to TGO 110 to be made in 2024.
From 1 March 2024, domestic manufacturers of vapes for smoking cessation or nicotine dependence will be required to provide pre-market notifications to the TGA declaring compliance with the relevant product standards, prior to the supply of those goods.
The 'Record-keeping obligations for sponsors' section of our current Guidance on TGO 110 sets out the types of information sponsors may want to request from manufacturers to meet their record-keeping obligations under TGO 110.
Wholesale supply of unapproved vapes
From 1 March 2024, unapproved vapes can be imported into, or manufactured by a GMP licensed manufacturer in, Australia and then wholesaled to an Australian pharmacy through one or more intermediate suppliers, provided that product requirements are met.
Wholesalers of vapes for smoking cessation or the management of nicotine dependence are subject to relevant state and territory requirements. For example, a wholesale licence for Schedule 4 (prescription only) medicines may be required from the relevant state or territory health department. Wholesalers may also need a licence under state and territory tobacco laws.
Applicants will need to meet the requirements under the relevant state or territory legislation. The TGA publishes the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (the Wholesale Code), which is implemented through the states and territories.
Please contact your relevant state or territory health department for further information about any wholesale supply requirements in your jurisdiction.
Reporting by Australian sponsors
Australian sponsors are required to submit a 6 monthly report to the TGA listing the brand and nicotine concentration of each kind of unapproved therapeutic vape the sponsor supplied in Australia under the AP and Special Access Schemes during the relevant period. Reporting periods are 1 January - 30 June (inclusive) and 1 July - 31 December (inclusive). Reports must be submitted within 1 month of the end of the relevant reporting period.
Fill in the sponsor six monthly reporting form.
Reports must be provided by email to firstname.lastname@example.org.
Personal importation by patients is not permitted
From 1 January 2024, the importation of all disposable vapes is banned, including importations of disposable vapes under the personal importation scheme, subject to very limited exceptions.
From 1 March 2024, the personal importation of all other vapes will be banned. Australian prescribers and patients considering ordering vapes from overseas before these changes take effect should be aware that Australian Border Force will seize and destroy all vapes that imported by customers in Australia from 1 March 2024. Fines may also be payable.
Patients importing reusable nicotine vapes between now and 1 March 2024 are required to have a valid prescription from an Australian-registered doctor to import vapes into Australia. Australian patients who import nicotine vapes from overseas retailers between now and 1 March 2024 are advised to arrange a copy of their prescription to be enclosed within the package that the vape is sent, to avoid the package being stopped and seized at the border.
Supplying vaping devices
Vaping devices, such as vapes, e-cigarettes and e-cigars, are electronic devices used to heat vaping substances for direct inhalation. Some vaping substances are supplied in vaping devices (e.g. prefilled). Other vaping devices including pods and cartridges are supplied separately to the vaping substances used with those devices.
Vaping devices for use with unapproved vaping substances (e.g. e-liquid) for smoking cessation or the management of nicotine dependence can be imported, manufactured and supplied in Australia without being included in the ARTG, subject to certain conditions.
From 1 March 2024, all vaping devices (including an unfilled cartridge, capsule, pod or other vessel) for use with a therapeutic vaping substance will be covered by the therapeutic goods framework. From this time, these devices will be required to comply with any one or more of the following requirements:
- ISO 9001 certification for the manufacture of the device, issued by an IAF accredited body
- ISO 13485 certification for the manufacture of the device, issued by an IAF accredited body;
- certification (or other approval) issued by an overseas regulator of compliance with the overseas regulator’s requirements for:
- consumer grade e-cigarettes, or
- therapeutic vapes
Therapeutic vaping devices that were already subject to the therapeutic goods regulatory scheme before 1 March 2024 (i.e. those that were previously intended for use exclusively with a medicine for inhalation) will continue to be required to comply with the Essential Principles. The Essential Principles apply to all medical devices, even those not included in the ARTG. Sponsors may apply to the TGA for consent for non-compliance with certain Essential Principles in exceptional circumstances.
Where therapeutic vaping goods are supplied in a pack, all goods in the pack, including therapeutic vaping devices and device components, will be required to comply with TGO 110.
The ‘Therapeutic vaping devices and therapeutic vaping device accessories’ section of the current Guidance on TGO 110 provides further information on how vaping devices are regulated by the TGA.
Subject to state and territory restrictions or requirements, pharmacists can hold stock and supply vaping devices for use with vaping substances. Please contact your relevant state or territory health department for further information (see vapes: information for pharmacists).
Applying for registration on the ARTG
To obtain ARTG registration for a therapeutic vaping substance, a sponsor will need to submit an application to the TGA to register the vape as a prescription medicine. A submission to register a prescription medicine 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 vaping substances that seek to be included in the ARTG 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'). Demonstrating conformance to the requirements of TGO 110 will not be sufficient to demonstrate the quality, safety and efficacy of a vaping substance for the purpose of ARTG registration.
Further information on registering prescription medicines in the ARTG is available on our Prescription medicines hub.
Advertising and promotion of vapes
The advertising of therapeutic goods, including vapes, is generally prohibited in Australia. Some states and territories also restrict the promotion of vaping devices.
The Government has announced that it will introduce legislation in 2024 to prevent advertising of all vapes, subject to limited exceptions.
Report side effects and problems
We strongly encourage sponsors and wholesale suppliers to report any suspected side effects related to vapes.
The TGA has an important role in monitoring the safety of 'unapproved' goods. Reporting side effects and problems helps us to understand the safety of a product. We investigate significant safety concerns as part of ensuring product safety in the Australian community.