This page provides an overview of how medical practitioners and nurse practitioners can prescribe vapes for smoking cessation or the management of nicotine dependence, and their obligations when doing so.
Vapes include vaping substances, vaping accessories and vaping devices.
Cannabis vapes are subject to separate strict regulations (see the Medicinal cannabis hub).
Vaping laws restrict supply to pharmacies
From 1 July 2024, new regulations apply to all vapes, including vaping devices, irrespective of nicotine content or therapeutic claims. This means:
- vapes are only available in pharmacies or in pharmacy settings
- it is illegal for retailers such as tobacconists, vape shops and convenience stores to supply any type of vape, even with a prescription.
Until 30 September 2024, patients need to speak with a medical or nurse practitioner to:
- get a prescription to buy vapes containing nicotine, and
- access zero-nicotine vapes
It is anticipated that prescribers will see an increase in patients seeking a prescription for therapeutic vapes, as the new laws prohibit the sale of vapes from non-pharmacy settings.
From 1 October 2024, therapeutic vapes with a nicotine concentration of 20mg/mL or less will be available in pharmacies to patients 18 years or over without a prescription. A pharmacist will need to be satisfied it is clinically appropriate, and meet several other conditions, to supply a vape to a patient without a prescription. These changes will help facilitate patient access while maintaining appropriate controls and protections.
Read more about the changes from 1 October 2024.
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).
Therapeutic goods that are not included in the ARTG are known as unregistered or ‘unapproved’ therapeutic goods. There are established pathways for patients to lawfully access unapproved goods, but these goods are not assessed by the TGA for quality, safety and efficacy or performance.
Vapes are associated with a range of health risks and there is limited evidence of their effectiveness for smoking cessation.
The risks associated with prescribing therapeutic vapes need to be considered in the context of the seriousness of the risks of continued smoking or vaping.
Guidance and resources for prescribers
Therapeutic vapes are not a first line treatment for smoking cessation or the management of nicotine dependence. There are a range of smoking cessation medicines and therapies available in Australia that have been evaluated and approved by the TGA that do not have the same health risks as vapes.
The Royal Australian College of General Practitioners has developed provisional guidance on supporting smoking and vaping cessation – including prescribing vapes (including for patients under 18): Supporting smoking cessation: A guide for health professionals.
The Quit Centre provides health professionals with the latest clinical information, resources and training on smoking and vaping cessation.
Prescribing unapproved vapes
Practitioners must comply with state, territory and Commonwealth laws to authorise the supply of therapeutic vapes.
State and territory laws require vapes containing nicotine to be prescribed.
As there are no therapeutic vapes for smoking cessation or the management of nicotine addiction on the ARTG, there are additional requirements under the Therapeutic Goods Act 1989. These requirements apply to all vaping substances, but not vaping devices.
Medical and nurse practitioners must use one of the following special access pathways, subject to state and territory law, to prescribe therapeutic vaping substances:
- Authorised Prescriber (AP) scheme – medical practitioners only
- Special Access Scheme C (SAS C) – both medical and nurse practitioners
- Special Access Scheme B (SAS B) – both medical and nurse practitioners.
A SAS/AP approval is not required to supply an unapproved therapeutic vaping device. However, such devices can only be supplied for smoking cessation or the management of nicotine dependence.
Authorised Prescriber (AP) scheme
- Medical practitioners only
- Separate approval NOT required for individual patients with same medical condition
- Must obtain written consent from each patient
- Application processed in 10 days
- Six-monthly reporting of patient numbers to TGA
- AP status remains valid for 5 years
A medical practitioner may apply for authority to become an Authorised Prescriber (AP) of unapproved therapeutic vaping substances (whether containing nicotine or not) for smoking cessation or management of nicotine dependence for patients 16 years or over without the need for ethics committee approval.
Ethics committee approval continues to be required to become an AP for supply to patients under 16 years of age (which is also subject to state and territory laws).
Approval as an AP of unapproved vapes is generally granted for five years. No further applications or permissions are required for the duration of the approval.
Submission of AP applications are made via the SAS and Authorised Prescriber Online System (see below).
APs must report to the TGA the number of patients treated every six months. These reports may also be submitted using the online portal if applications are submitted online.
Special Access Scheme C (SAS C)
- Medical practitioners and nurse practitioners
- Notification system only, no TGA pre-approval required
- Notification for each patient required
- Product can be accessed immediately
- Submit notification online within 28 days of supply
- Retain online submission receipt with patient’s medical record
- Pharmacist can submit notification online on behalf of the prescriber
- SAS C notification is valid indefinitely, if patient continues to meet the criteria.
The Special Access Scheme C (SAS C) pathway has been available since 1 January 2024 to facilitate legitimate patient access to therapeutic vaping substances, irrespective of nicotine content, where clinically appropriate. SAS C is available for patients 16 years or over.
This pathway applies to both medical and nurse practitioners.
When using this pathway, you must submit an online notification form to the TGA within 28 days of prescribing the unapproved vape. The notification form is available via the SAS and Authorised Prescriber Online System (see below).
A notification under SAS C that is submitted to the TGA in the online system will generate a notification number that will be immediately accessible to registered pharmacists.
This means that a registered pharmacist will be able to verify that supply has been made in accordance with the new SAS C pathway for smoking cessation or the management of nicotine dependence prior to dispensing a therapeutic vaping substance to a patient. It is best practice to submit the notification at the time of prescribing to allow for efficient dispensing by the pharmacist.
Special Access Scheme B (SAS B)
- Medical practitioners and nurse practitioners
- Single patient access
- Use if unapproved product cannot be accessed through categories A or C
- Submit application online to TGA
- Need approval letter from TGA before prescribing
The SAS B pathway provides authority for certain health practitioners to supply an unapproved therapeutic good to a single patient on a case-by-case basis. A new application must be submitted to the TGA for every patient you wish to prescribe therapeutic vapes.
The SAS B pathway may be a suitable pathway for certain clinical situations such as for smoking cessation or management of nicotine dependence in patients under 16 years of age.
Depending on state or territory restrictions, other prescribing health practitioners may be able to apply under the SAS B pathway. However, they would need to demonstrate they have the required qualifications and expertise in the use of the product.
More information about SAS B and SAS C can be found on the Special Access Scheme webpage.
AP and SAS online system
Use the SAS and Authorised Prescriber Online System to make an AP and SAS application or submission.
A step-by-step guide to using the SAS and AP portal to prescribe therapeutic vapes is available in this demonstration video.
You can also refer to the Authorised Prescriber user guidance: Special Access Scheme & Authorised Prescriber Scheme Online System.
MBS items
There are a range of MBS items that may be used to support doctors and nurse practitioners to provide services to patients for smoking cessation and the management of nicotine dependence.
Doctors and nurse practitioners should choose the most appropriate MBS item according to their provider type and the circumstances of the consultation.
Product standards for unapproved vapes
For lawful supply in Australia, unapproved therapeutic vapes that are used for smoking cessation or the management of nicotine dependence must comply with:
- the Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 (TGO 110) product standards (if they are vaping substances)
- either:
- the Essential Principles, or
- the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023 (MDSO) (if they are vaping devices).
Sponsors must notify the TGA that their products comply with applicable standards before they are introduced into the Australian market.
Therapeutic vaping substances
The requirements in TGO 110 apply to therapeutic vapes that are intended to be used 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 vapes (including therapeutic vaping devices and unfilled pods and cartridges).
Under TGO 110, among other things:
- flavours are restricted to mint, menthol and tobacco
- the maximum nicotine concentration limit is 100 mg/mL (base form or equivalent base form concentration).
This means that even with a prescription, patients cannot access products that do not comply with these requirements.
This does not mean that unapproved vapes that comply with TGO 110 have TGA approval. The long-term health risks of unapproved vapes, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation or the management of nicotine dependence is limited.
It is anticipated that TGO 110 will be further strengthened by late 2024 or early 2025, including to reduce permissible nicotine concentrations and require plain pharmaceutical packaging.
More information can be found in the TGA’s Guidance for Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and related matters.
Therapeutic vaping devices and accessories
Therapeutic vaping devices are electronic devices used to heat therapeutic vaping substances for direct inhalation. Some vaping substances are supplied in or with therapeutic vaping devices. Other therapeutic vaping devices are supplied separately to the vaping substance(s) used with those devices.
On 1 March 2024, all therapeutic vaping devices and accessories that are imported or manufactured for use with a therapeutic vaping substance were brought within the therapeutic goods regulatory framework.
Therapeutic vaping devices that were already subject to the therapeutic goods regulatory framework before 1 March 2024 are still required to comply with the Essential Principles. Sponsors may apply to the TGA for consent for non-compliance with certain Essential Principles in exceptional circumstances.
Therapeutic vaping devices that were previously excluded from regulation under the Therapeutic Goods Act 1989 are required to comply with the MDSO.
Where therapeutic vapes are supplied in a pack, all goods in the pack, including therapeutic vaping devices, will be required to comply with TGO 110.
The MDSO is also anticipated to be strengthened by late 2024 or early 2025 to require plain packaging and align with the TGO 110, where possible. This is expected to include new requirements for instructions for use, labelling and plain design for the vaping device or accessories. In addition, certain product specific requirements for manufacturers are expected to apply, including, for example, toxicological risk assessment, Australian electrical safety standards and international battery standards.
List of notified vapes
The TGA maintains a list of vapes, which includes vaping substances, vaping accessories and vaping devices that have been notified as complying with applicable product standards for supply in Australia. The only vaping products that can lawfully supplied are the products on this list.
Prescribers can refer to this list to guide decisions about prescribing. The list includes details about product type, nicotine form (either salt or freebase), flavour and concentration.
Advertising and promotion of vapes
The advertising of vapes is prohibited except where expressly permitted by the Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024.
The Therapeutic Goods (Vaping Goods—Advertising) Authorisation 2024 authorises limited advertising of notified therapeutic vaping goods including:
- on the label and packaging of the goods
- advertising directed exclusively to medical practitioners, nurse practitioners, pharmacists and their practice managers and purchasing officers
- advertising directed exclusively to businesses involved in the wholesale of notified therapeutic vaping goods
- advertising that is advice or information given directly by a medical practitioner, nurse practitioner or pharmacist to a patient in the course of treatment.
Strict conditions apply to advertising conducted in each of these circumstances, as outlined in the legal instrument. This includes specifying the type of information that can be included in the advertisement, for example:
- the availability and price of the goods
- information on the safe and effective use of the goods
- details on the goods, such as intended purpose, ingredients, and design specifications.
Only therapeutic vaping goods that have been notified to the TGA as complying with the applicable product standards can be advertised in accordance with the permissions listed above.
The term ‘directed exclusively’ is used in the authorisation. This should be interpreted as ‘to the exclusion of others’ ensuring that only the relevant health practitioner or wholesaler receives the advertising content.
The TGA will publish further guidance on the advertising authorisation.
Severe penalties apply for non-compliant advertising or promotion.
Reporting side effects and problems
Prescribers are responsible for reporting adverse events or defects arising from the use of ‘unapproved’ therapeutic goods accessed under the Special Access Scheme pathways to the TGA.
We encourage patients and health practitioners to report any suspected side effects or malfunctions related to vapes.
Reporting perceived breaches or questionable practices
We encourage you to report any perceived breach of the Therapeutic Goods Act 1989 or questionable practices relating to the importation, manufacture, supply or advertising of therapeutic vapes to the TGA.
This includes the supply of vapes containing nicotine by a retailer other than a pharmacist (e.g. by a vape store).
Vapes present a poisoning risk
Nicotine poisoning can affect anyone of any age. However, the greatest risk of nicotine poisoning is in children because of their lower body weight – small quantities of the vaping substance (3-10 mL) can be fatal to children without medical intervention.
Nicotine can enter the body through:
- absorption through the skin if a vaping substance is spilled on the skin or touched
- inhalation into the lungs, or
- ingestion of vaping substances.
Symptoms of nicotine poisoning include nausea and vomiting, headaches, dizziness, breathing difficulties, seizures and cardiac arrest.
If the vaping substance is spilled on the skin, flush skin with running water.
If the vaping substance is in the eyes, flush immediately with running water.
Seek immediate medical attention if you think that you, or anyone else, may have been exposed to, or ingested, a vaping substance.
For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor.
Guidance and resources for prescribers
- RACGP: Supporting smoking cessation: A guide for health professionals
- Quit Centre - Quit Centre provides health professionals with the latest clinical information, resources and training on smoking and vaping cessation.