Vapes for the management of smoking cessation or nicotine dependence can only be sold at participating pharmacies. This applies to all vapes, including those that do not contain nicotine.
From 1 October 2024 pharmacists will be able to supply vapes with a nicotine concentration of 20 mg/mL or less to people 18 years or over without a prescription subject to certain conditions and state and territory law.
A prescription will continue to be required to dispense a therapeutic vape in some instances.
A prescription from a medical or nurse practitioner will be required for nicotine concentrations greater than 20 mg/mL.
People under 18 years of age will require a prescription to access vapes, where state and territory laws allow.
A prescription may also be required under state and territory legislation, or if the patient is assessed as having more complex medical needs and requires additional advice and support from a medical practitioner.
Prescribers are under no obligation to prescribe therapeutic vapes. Pharmacists cannot be compelled to stock or supply therapeutic vapes, regardless of whether a patient holds a prescription.
Cannabis vapes are subject to separate strict regulations (see the Medicinal cannabis hub).
Clinical resources
- RACGP: Supporting smoking cessation: A guide for health professionals
- PSA: Guidelines for pharmacists providing smoking cessation support
- Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age.
- Eligibility for Nicotine Replacement Therapies – Advice for health professionals December 2023
- Quit Centre - information, resources and training for health professionals on smoking and vaping cessation.
- Quit.org.au - information, advice and tools for individuals wanting to quit smoking or vaping.
State and territory requirements
Additional rules relating to vape products vary between states and territories and could affect whether or not vapes can be lawfully prescribed, dispensed and supplied in your state or territory.
There are also state and territory restrictions and requirements in many jurisdictions relating to prescribing, dispensing and supply to persons under 18 years of age.
Read more about Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age.
Prescribers should check with their relevant state or territory health department for further information to confirm current requirements in their respective jurisdiction.
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 unapproved therapeutic goods. 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 or the management of nicotine dependence.
There are established unapproved access pathways for prescribers to lawfully access unapproved vapes for patients under their care, if clinically appropriate.
Prescribing unapproved vapes
Before you apply to access an unapproved product, you should:
- consider approved products for your patient's medical condition
- consider risks of treatment
- obtain informed consent
- comply with state, territory and Commonwealth laws to prescribe and supply therapeutic vapes
- adhere to relevant standards of good medical practice
The Special Access Scheme and Authorised Prescriber scheme
There are four pathways for accessing unapproved vapes for smoking cessation or management of nicotine dependence.
Learn more about the pathways for accessing unapproved products.
| Authorised Prescriber - Established History of Use pathway | For medical practitioners for patients over 16 years. |
| Authorised Prescriber - Standard pathway | For medical practitioners for patients under 16 years. |
| SAS C notification pathway | For medical practitioners and nurse practitioners for patients over 16 years. For pharmacists for patients over 18 years AND for nicotine 20mg/mL or less. |
| SAS Category B application pathway | For medical practitioners and nurse practitioners for patients under 16 years |
*Please note state and territory restrictions for persons under 18 years of age (see above).
Vaping devices that do not contain, and are not packaged with, a vaping substance do not need to be prescribed or authorised for supply under the AP or SAS schemes. However, such devices can only be supplied by a medical practitioner, nurse practitioner or pharmacist for smoking cessation or the management of nicotine dependence.
AP and SAS online system
Use the SAS and Authorised Prescriber Online System to make an AP and SAS application or submission.
These YouTube videos explain:
- how to use the SAS and AP portal: Account registration - SAS & AP Online System Guidance - YouTube
- how health practitioners can make a SAS C S4 nicotine submission: SAS C S4 Nicotine Submission user guide
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 medical practitioners and nurse practitioners to provide services to patients for smoking cessation and the management of nicotine dependence.
Medical practitioners and nurse practitioners should choose the most appropriate MBS item according to their provider type and the circumstances of the consultation.
Product standards and notified vape list
Pharmacies must only source and supply therapeutic vapes for smoking cessation or the management of nicotine dependence that are compliant with the TGA product standards and included on the TGA’s list of notified vapes.
The listed vapes have not been assessed by the TGA for quality, safety and efficacy or performance, but may be lawfully imported, manufactured and supplied as unapproved therapeutic goods, subject to the regulatory requirements.
Read more about the product standards.
Restrictions on the 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.
Health professionals can communicate specific information about therapeutic vapes to patients in the course of treatment.
Read more about advertising and promotion requirements.
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 SAS and AP 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.