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Nicotine vaping products: Information for prescribers
- Nicotine vaping product access
- Standard for unapproved and export only nicotine vaping products
- Nicotine vaping products: Frequently Asked Questions
- Authorised Prescribers of unapproved nicotine vaping products
- Guidance for the use of nicotine vaping products for smoking cessation
- Accessing unapproved products
- Compliance and enforcement
This page provides an overview of how medical practitioners can prescribe nicotine vaping products for their patients where appropriate and their obligations when doing so. It also applies to other health practitioners, such as nurse practitioners, who may be authorised to prescribe these products.
Nicotine vaping products are prescription medicines
From 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.
Nicotine vaping products are 'unapproved' products
There are currently no nicotine vaping products approved by the Therapeutic Goods Administration (TGA) and registered in Australian Register of Therapeutic Goods (ARTG). Medicines that are not in the ARTG are known as 'unapproved' medicines. There are established pathways for consumers to legally access to unapproved nicotine vaping products, with a valid prescription, but these medicines have not been assessed by the TGA for safety, quality and efficacy.
There are various smoking cessation aids registered in the ARTG, including many NRTs and some prescription medicines, which have been assessed by the TGA for safety, quality and efficacy. There are also non-pharmaceutical approaches to smoking cessation.
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 comes into effect on 1 October 2021. TGO 110 includes minimum safety and quality requirements for unapproved nicotine vaping products.
This does not mean that unapproved nicotine vaping products that comply with TGO 110 have TGA approval. The long-term health risks of unapproved nicotine vaping products, even those that comply with TGO 110, are still unclear and the evidence of their potential efficacy for smoking cessation is currently mixed.
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).
Prescribing unapproved nicotine vaping products
The Royal Australian College of General Practitioners (RACGP) Supporting smoking cessation: A guide for health professionals (RACGP Guidelines) stipulate that nicotine vaping products are not first line treatment for smoking cessation. However, for people who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to stop smoking and have discussed nicotine vaping product use with their healthcare practitioner, nicotine vaping products may be a reasonable intervention to recommend.
Product choice and writing prescriptions
There has been a focussed update to the RACGP Guidelines to provide additional guidance on nicotine vaping products, such as:
- Evidence on the place of nicotine vaping products in supporting smoking cessation, including updated information about the clinical efficacy evidence currently available
- Information on what is known about the safety of nicotine vaping products
- Advice on prescribing of unapproved nicotine vaping products, including risk-minimisation strategies, factors to consider when determining which product to prescribe and what should be included on the prescription.
Prescribers need to consider what nicotine concentration and type of product is appropriate for a particular person’s smoking cessation needs. Consumers will only be able to access a product with a concentration matching that specified in their prescription.
TGO 110 sets a maximum nicotine concentration limit for unapproved nicotine vaping products of 100 mg/mL (base form or equivalent base form concentration). Even with a prescription, consumers will not be able to access products with a concentration above this limit. This does not mean that products with a concentration of 100 mg/mL are safe or necessarily appropriate for use. The ‘Limits on nicotine concentration’ section of our Guidance on TGO 110 includes information on the risks of higher concentration products that require 'at-home mixing' (i.e. dilution by consumers) prior to use.
Practical information for prescribers, including to raise awareness of how to prescribe nicotine vaping products in Australia, is also available in our Guidance for the use of nicotine vaping products for smoking cessation.
Use an established access pathway
If you determine that an unapproved nicotine vaping product is clinically suitable for your patient, there are three main pathways through which the person will be able to access the product on your prescription:
If the person intends to fill their prescription at an Australian (physical or online) pharmacy, you will need to apply to the TGA for approval to supply the nicotine vaping product through the AP Scheme (medical practitioners only) or the SAS Category B (SAS B) before you provide a prescription.
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.
A flow chart outlining the steps leading to dispensing the prescription is set out below.
Personal Importation Scheme
The Personal Importation Scheme allows Australian residents or visitors to import certain medicines from overseas for their own personal use or the use of an immediate family member, subject to conditions. A valid prescription from an Australian-registered medical practitioner is required to import unapproved nicotine vaping products under the Personal Importation Scheme. The product can only be imported for use by the person named on the prescription, even if it is imported by an immediate family member on their behalf.
Any medical practitioner who considers it appropriate for their patient to use nicotine vaping products for smoking cessation can prescribe those products for personal importation. Medical practitioners do not need TGA authorisation or approval to prescribe unapproved nicotine vaping products for access through the Personal Importation Scheme.
Individuals may import up to a three month supply of medicines per import (based on the maximum daily dose recommended by the manufacturer), but not exceed 15 months supply in a 12-month period. They must arrange for a copy (scan or photocopy) of their prescription to be enclosed with the package the product is sent in. Australian Border Force (ABF) officials can stop the import at the Australian border if they suspect it is an unlawful import. If there is no prescription enclosed in the package, the ABF will refer the import to the TGA for assessment. If a copy of the prescription is not provided, the TGA can request that the ABF seize and forfeit (destroy) the goods. Individuals may also face penalties for importing a prescription medicine without legal authority.
If a patient needs to import more than a three month supply in a single import, you will need to apply for access to the product through the AP Scheme or SAS B before providing the prescription.
Make enquiries of overseas retailers
Products purchased from overseas are subject to some, but not all, of the requirements under TGO 110, but the TGA cannot enforce the requirements in the new standard against overseas retailers.
If you are considering prescribing for the Personal Importation Scheme, you are encouraged to confirm (or have the patient confirm) with the overseas supplier whether the product you are considering meets the applicable requirements in TGO 110 and also has child-resistant packaging, appropriate labelling and manufacturing controls. You can find a list of questions to ask a supplier of nicotine vaping products on our website.
Authorised Prescriber (AP) Scheme
A medical practitioner may apply for authority to become an 'Authorised Prescriber' of unapproved nicotine vaping products as an aid to stop smoking without the need for ethics committee approval. The application covers nicotine in solution, salt or base form, for use in smoking cessation. Ethics committee approval continues to be required to become an AP of heat-not-burn tobacco products.
Approval as an AP of unapproved nicotine vaping products is generally granted for five years. For the duration of the five year period, no further applications or permissions are required.
Submission of AP applications via the SAS & Authorised Prescriber Online System is preferred to reduce processing times. For instructions, refer to the Authorised Prescriber user guidance: Special Access Scheme & Authorised Prescriber Scheme Online System. A simplified nicotine-specific online form is available on the AP dashboard of the SAS & Authorised Prescriber Online System. After registering an account, medical practitioners can select the "New Nicotine AP application" button and the required form fields will be pre-filled ready for submission.
If there are technical issues, a downloadable nicotine-specific application form is available below:
- Form: Authorised Prescriber Scheme - NICOTINE only (pdf, 84kb)
- Form: Authorised Prescriber Scheme - NICOTINE only (docx, 53kb)
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.
List of APs of unapproved nicotine vaping products
The TGA has released a list of APs of unapproved nicotine vaping products who have consented to have their name and consulting location published.
You can consent to have your name and consulting location included in the list when you complete your application to become an Authorised Prescriber of nicotine. Existing APs who wish to have their names and consulting location included in the list should complete the following form and return it to email@example.com. Names can take up to one month to be published.
- Form: Authorised Prescriber Scheme - Nicotine Vaping Products (pdf, 87kb)
- Form: Authorised Prescriber Scheme - Nicotine Vaping Products (docx, 122kb)
The TGA will only publish your name and consulting location with your consent. Your AP authority will remain valid even if you choose not to have your details published.
This infographic is a printable resource that can be used to communicate the streamlined approval process for medical practitioners.
Special Access Scheme (SAS)
The SAS B provides for the import and supply of 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 nicotine vaping products.
For more information about the SAS B and how to submit an application, refer to the Special Access Scheme webpage. The SAS and Authorised Prescriber Online System is the preferred method of submission to reduce processing times for applicants.
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.
Most vaping devices are not medical devices for the purpose of the TGA's framework. The 'Vaping devices' section on our Guidance on TGO 110 provides further information on the types of vaping devices that are and are not regulated by the TGA. Practical information for prescribers, including on the different types of vaping devices, is also available in our Guidance for the use of nicotine vaping products for smoking cessation.
No AP or SAS B approval is required to access a vaping device alone. If an unapproved nicotine vaping product is supplied in or with a vaping device, the unapproved nicotine vaping product must be accessed under one of the supply pathways for unapproved goods (e.g. under an AP approval), but no separate AP or SAS B approval is required for the vaping device itself.
Temporary MBS Services for Nicotine and Smoking Cessation Counselling
The Government has introduced 18 new temporary items relating to nicotine and smoking cessation into the Medicare Benefits Schedule (MBS). The new temporary items include six face-to-face, six telehealth and six phone services. These items are temporary and will be in place until 30 June 2022.
Advertising and promotion of nicotine vaping products and related services
The advertising of prescription medicines, including nicotine vaping products, to consumers is generally prohibited in Australia. You must not refer, either expressly or impliedly, to unapproved nicotine vaping products in your company, business or trading name nor in any other promotional material relating to your health service or business.
However, information shared between a health practitioner and their patient during consultation or treatment is not subject to the advertising rules for therapeutic goods, including the prohibition on advertising prescription medicines. Presenting factual and balanced information about using nicotine vaping products is also unlikely to be considered advertising, depending on the context in which the information is presented.
Further information on how you can lawfully refer to nicotine vaping products and promote your services is available in our guidance on Advertising nicotine vaping products to the Australian public.
We strongly encourage consumers and health practitioners 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.
Reporting perceived breaches or questionable practices
We encourage you to report any perceived breach of the Therapeutic Goods Act 1989 or questionable practices in relation to the import, manufacture, supply, export or advertising of nicotine vaping products to the TGA. This includes the sale of nicotine vaping products by a retailer other than a pharmacist (e.g. by a vape store).
Nicotine vaping products present a poisoning risk
Accidental ingestion of, or exposure (such as through the skin or eyes) to, nicotine vaping products can have toxic, and sometimes severe, effects. When prescribing nicotine vaping products, you should advise your patient of the risk of accidental child poisoning if the container is left open in the process of refilling/mixing of nicotine vaping products (where relevant) and/or if nicotine vaping products are used in vaping devices without child-resistant safety features (including where a child is able to suck on the vaping device).
Consumers should seek urgent medical attention if they think that they, or anyone else, may have been exposed to or ingested a nicotine vaping product. Emergency services can be contacted by calling 000 and the Poisons Information Centre can be contacted by calling 131 126.