Nicotine vaping products: Information for sponsors, wholesalers and manufacturers

This page provides an overview of how Australian sponsors can import, manufacture, supply and export nicotine vaping products and how wholesalers can supply nicotine vaping products to Australian pharmacies.

Nicotine vaping products are prescription medicines

As of 1 October 2021, all nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, are Schedule 4 (prescription only) medicines. Consumers require a prescription for all purchases of nicotine vaping products. This includes purchases from Australian pharmacies and overseas. It remains illegal for other Australian retailers, such as tobacconists, 'vape' shops and convenience stores, to sell consumers nicotine vaping products. Further information about the reasons for this change is available on the Nicotine vaping product access page.

Nicotine replacement therapies (NRTs) (including sprays, patches, lozenges, chews and gums) that do not require a prescription will continue to be available from pharmacies and some retail outlets.

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Unapproved and export only nicotine vaping products

Generally, prescription medicines must be approved by the Therapeutic Goods Administration (TGA) and registered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, or supplied in, Australia.

There are currently no TGA approved nicotine vaping products registered in the ARTG. Medicines that are not in the ARTG are known as ‘unapproved’ medicines. The pathways through which unapproved nicotine vaping products can be imported, manufactured and supplied are outlined below.

Prescription medicines that are intended for export only must generally be listed in the ARTG prior to export. These are known as ‘export only’ products. Export only nicotine vaping products are not subject to TGA assessment prior to listing in the ARTG.

Product standard for unapproved and export only nicotine vaping products

The TGA has introduced a standard for unapproved and export only nicotine vaping products, known as the Therapeutic Goods (Standard for Nicotine Vaping Products (TGO 110) Order 2021 (TGO 110), that came into effect on 1 October 2021. TGO 110 includes minimum safety and quality requirements for unapproved and export only nicotine vaping products. It includes rules about:

• product labelling (including an oversticker or in an information sheet provided with the product)
• childresistant packaging
• maximum nicotine concentration (although people will still only be able to access the nicotine concentration in their prescription)
• requiring actual nicotine concentration/content to reflect what the product's label says
• prohibited ingredients
• records that need to be kept by the Australian sponsor for the product.

Some, but not all, of the requirements of TGO 110 apply at the time a product is imported into, or exported from, Australia. All of the requirements of TGO 110 apply when the products are supplied within Australia. Australian sponsors of unapproved and export only nicotine vaping products must maintain records demonstrating conformance to the requirements of TGO 110.

Further information on the requirements of TGO 110 is available in our Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021 and related matters (Guidance on TGO 110).

Product quality

Unapproved and export only nicotine vaping products that are subject to TGO 110 are not required to comply with monograph(s) in the British Pharmacopoeia, European Pharmacopoeia or United States Pharmacopeia-National Formulary that would otherwise apply to those products as default standards.

Unapproved products (other than those imported via the Personal Importation Scheme) will need to comply with subsection 11(1) of the Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018. This standard does not apply to export only products.

The ‘Contaminants and product quality’ section of our Guidance on TGO 110 provides further information for Australian sponsors and manufacturers regarding product quality and potentially harmful contaminants that may be present in nicotine vaping products and/or their aerosols.

Importing, manufacturing and supplying unapproved nicotine vaping products

Recent regulatory changes allow unapproved nicotine vaping products to be imported into, or manufactured (by a GMP licensed manufacturer) in, Australia and wholesale supplied (e.g. to Australian pharmacies) through one or more intermediate suppliers.

The Australian sponsor, manufacturer or wholesale supplier undertaking the activity must have a reasonable expectation that the unapproved nicotine vaping product will ultimately be supplied to a consumer under the Authorised Prescriber (AP) scheme, the Special Access Scheme Category B (SAS B) or the Clinical Trial Approval (CTA) scheme. However, the sponsor does not need to maintain direct control over the unapproved nicotine vaping product throughout the supply chain.

In particular, the Australian sponsor, manufacturer or wholesaler can import, manufacture and/or supply the unapproved product prior to the pharmacy receiving a prescription under the Authorised Prescriber (AP) scheme or Special Access Scheme Category B (SAS B). This means that pharmacies can keep unapproved nicotine vaping products in their dispensaries for the purpose of dispensing, but prior to the receipt of, prescriptions under the AP scheme or SAS B.

Unapproved nicotine vaping products continue to be able 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.

Importation declarations

There is no requirement for sponsors to notify the TGA prior to importing unapproved nicotine vaping products.

Sponsors will, however, need to make an import declaration to the Australian Border Force (ABF). The type of declaration required will depend on the value of the goods being imported. Information about the ABF's requirements is available on the ABF's 'Declaration for imported goods' webpage. The ABF can also be contacted via its website or on 02 6196 0196.

Manufacturing practices

Australian manufacturers of unapproved nicotine vaping products must obtain a GMP licence from the TGA, unless a relevant exemption applies.

A GMP licence is not required to manufacture unapproved nicotine vaping products at manufacturing sites outside Australia. GMP clearance is also not required where unapproved nicotine vaping products are manufactured overseas and supplied in Australia via the APS, SAS B 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 and, in particular, will need to maintain records demonstrating that the product conforms to the requirements of TGO 110.

The 'Record-keeping obligations for Australian sponsors' section of our 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

A wholesale licence for Schedule 4 (prescription only) medicines must generally be obtained from the relevant state or territory health department to wholesale supply nicotine vaping products. 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 (Wholesale Code), which is implemented through the states and territories.

People who wholesale supply nicotine vaping products or vaping devices within Tasmania, or to Australian pharmacies in the ACT, may also need a licence to sell smoking/tobacco products from the Tasmanian or ACT health department (as relevant).

Please contact your relevant state or territory health department for further information about any of the wholesale licence requirements. Enquiries about licences to sell smoking/tobacco products into the ACT may also be made to the Health Protection Service at 02 6205 2155 or HPS@act.gov.au.

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 nicotine vaping product the sponsor supplied in Australia in 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 eps@health.gov.au.

Registering a nicotine vaping product in the ARTG

To obtain ARTG registration for a nicotine vaping product, the sponsor will need to submit an application to the TGA to register the nicotine vaping product 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.

Nicotine vaping products that seek to be registered 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 nicotine vaping product for the purpose of ARTG registration.

If the nicotine vaping product is supplied in a vaping device (e.g. prefilled, disposable nicotine e-cigarettes and nicotine pods), the TGA will consider the vaping device in assessing the safety, quality and efficacy of the nicotine vaping product. No separate application is required for the vaping device, as vaping devices for use with nicotine vaping products do not need to be included in the ARTG.

Further information on registering prescription medicines in the ARTG is available on our Prescription medicines hub.

Overseas retailers supplying direct to Australian consumers

From 1 October 2021, consumers are required to have a valid prescription from an Australian-registered doctor to import nicotine vaping products into Australia. Australian consumers that order products from overseas retailers are advised to arrange for a copy of their prescription to be enclosed within the package the nicotine vaping product is sent in, to avoid the package being stopped at the border. Overseas retailers may want to update their ordering processes for Australian consumers to enable this to occur.

Australian doctors and consumers considering using the Personal Importation Scheme are also being encouraged to check with overseas retailers as to whether products meet the TGO 110 requirements for importation and otherwise have child-resistant packaging, appropriate labelling and manufacturing controls.

The 'Personal Importation Scheme' section of our Guidance on TGO 110 includes a list of questions that Australian doctors and consumers might ask overseas retailers and provides information that overseas retailers might find helpful in responding to those enquiries.

Supplying vaping devices

Vaping devices, such as vapes, e-cigarettes and e-cigars, are electronic devices used to heat nicotine vaping products for inhalation. Some nicotine vaping products are supplied in vaping devices (e.g. prefilled, disposable nicotine e-cigarettes and pods). Other vaping devices are supplied separately to the vaping product(s) used with those devices.

Vaping devices that are for use with unapproved nicotine vaping products can be imported into, manufactured and/or supplied (including wholesale supplied) in Australia without being included in the ARTG. No AP or SAS approval, or clinical trial approval or notification, is required for these devices. However, if the vaping device contains or is supplied with an unapproved nicotine vaping product (e.g. prefilled nicotine e-cigarettes and nicotine pods), the import, manufacture and supply requirements for unapproved nicotine vaping products continue to apply to the nicotine vaping product (i.e. the nicotine vaping product might be supplied under an AP approval, but no separate AP, SAS or clinical trial approval is required for the vaping device).

Most vaping devices are not medical devices for the purpose of the TGA's framework. Vaping devices that are medical devices must meet the Essential Principles and may be subject to recall action if they do not. The 'Vaping devices' section of our Guidance on TGO 110 provides further information on the types of vaping devices that are and are not regulated by the TGA, and how those devices are regulated by the TGA.

People who wholesale supply vaping devices within Tasmania, or to Australian pharmacies in the ACT, may also need a licence to sell smoking/tobacco products from the Tasmanian or ACT health department (as relevant). Please contact the Tasmanian health department or Health Protection Service of the ACT Department of Health (on 02 6205 2155 or at HPS@act.gov.au) (as relevant) for further information.

Products that resemble tobacco products, including vaping devices, cannot be sold by tobacco or general retailers in WA. However, registered pharmacists are permitted to dispense nicotine vaping products that are Schedule 4 (prescription) medicines and may supply a vaping device designed and intended for delivery of prescribed nicotine vaping products, as part of a medically supervised smoking cessation program.

Advertising and promotion of nicotine vaping products and vaping devices

The advertising of prescription medicines, including nicotine vaping products, to consumers is generally prohibited in Australia. A number of states and territories also restrict the promotion of vaping devices.

Further information on how you can lawfully refer to nicotine vaping products and vaping devices and promote your services is available in our guidance on Advertising nicotine vaping products to the Australian public.

Report side effects and problems

We strongly encourage sponsors and wholesale suppliers to report any suspected side effects related to nicotine vaping products.

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