Prescriber Information Hub
The regulatory framework governing therapeutic vapes
Since 2021, vapes may only be accessed through pharmacies to aid smoking cessation and/or the management of nicotine dependence.
The maximum permitted nicotine concentration for therapeutic vapes is 50 mg/mL under prescription by either a GP or NP, while therapeutic vapes with a concentration of 20 mg/mL or less may be supplied by pharmacists without a script.
No vaping products are currently listed on the ARTG. As a result, the TGA has created new streamlined pathways to enable clinicians to prescribe therapeutic vapes as unapproved medicines.
Vapes that are supplied or dispensed for therapeutic use must:
- Adhere to the standards set out in the Therapeutic Goods (Standard for Therapeutic Vaping Goods) Order 2021 (TGO 110) and the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023 (MDSO) and
- Be prescribed or supplied by persons authorised to do so under one of the Special Access Scheme pathways for unlicensed medicines.
Who may provide access to therapeutic vapes under the TGA’s regulatory framework?
As of 1 October 2024, the regulations permit the prescribing and dispensing of therapeutic vapes through the following pathways:
Authorised Prescriber (AP) Scheme
GPs who are registered as APs are pre-approved by the TGA to prescribe nicotine.
The script must note the AP’s MAP number and a copy of the TGA Authorisation letter must be provided with the script.
Special Access Scheme B (SAS-B)
Used to seek TGA approval for GPs to prescribe to patients who have presented with complicating factors:
- Below the age of 18;
- Pregnancy; and
- Comorbidities.
The script must note the SAS approval number and a copy of the TGA approval letter must be provided with the script.
Special Access Scheme C (SAS-C)
A notification process for prescribing NVPs to patients 18 or older is available to:
- GPs or NPs: All therapeutic vapes; and
- Pharmacists: Therapeutic vapes of nicotine concentration of 20 mg/mL or less.
Where prescribed, the script must note the SAS notification number and a copy of the TGA notification must be provided with the script.
Australia’s standards for therapeutic vaping products (TGO 110) and for vaping devices and accessories (MDSO)
TGO 110 outlines the requirements that manufacturers must adhere to in order for their vaping products to be supplied as therapeutic vapes.
Key requirements of TGO 110 include the following:
| Restriction | Requirement | Implemented |
|---|---|---|
| Maximum concentration | By prescribers: 50 mg/mL | From 1 July 2025 |
| By pharmacists: 20 mg/mL | Yes | |
| Permitted ingredients | Nicotine Vegetable glycerin (VG) Propylene glycol (PG) Flavouring | Yes |
| Prohibited ingredients | List as specified in TGO 110 | Content Iota |
| Testing requirements | Content Lambda | Content Mu |
Key requirements of MDSO include the following:
| Restriction | Requirement | Implemented |
|---|---|---|
| Device manufacturing quality requirements | Content Beta | From 1 July 2025 |
| Labelling and packaging requirements | Content Epsilon | From 1 July 2025 |
Manufacturers are required to confirm that all therapeutic vaping products that they sponsor comply with the requirements of TGO 110 and MDSO.
The TGA has published a list of notified therapeutic vaping products. As at 30 September 2024:
- List of notified vaping substances, substance accessories, and kits comprised 948 entries; and
- List of notified vape devices and device accessories comprised 788 entries.
IMPORTANT Not all vapes are created equal
We have compiled a list of questions you need to ask before prescribing a particular brand of vaping product.
View TGA list of all notified therapeutic vaping products
Therapeutic vapes and state-based tobacco regulations
Therapeutic vapes supplied under prescription are medicines / medical devices, and are not considered to be ‘tobacco products’ under federal legislation.
However, there remain some conflicts between Federal and State/Territory laws in states that have not specifically exempted therapeutic vapes.
In these states, these conflicts typically relate to the sale or dispensing of therapeutic vapes and do not impinge upon a prescriber’s ability to prescribe them in line with typical good clinical practices.
Note for Northern Territory-based prescribers
In the Northern Territory, therapeutic vaping devices may only be dispensed under prescription – this is a mandatory legislative requirement. Clinicians must remember to include provision of the vaping device on any script.
Request a prescriber pack
Become an Authorised Prescriber
Register as an Authorised Prescriber to prescribe therapeutic vapes for smoking cessation or nicotine dependence
external link (health.gov.au)
Liber:Onboard
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Important links
Therapeutic Goods Administration (TGA)
Royal Australian College of General Practitioners (RACGP)
References
- PSA Professional Practice Standard 1: https://www.psa.org.au/practice-support-industry/pps/
© 2024 Liber Pharmaceuticals Ltd. All content
iNRT Healthcare is operated by Liber Pharmaceuticals for the purpose of furthering healthcare education regarding Nicotine Vaping Products (NVPs) within the Australian medical framework. Liber has no affiliation with the tobacco industry, their affiliates, or any organisations or individuals engaged in lobbying on their behalf.
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