You are here

Accessing e-cigarettes containing nicotine

3 November 2020

Electronic cigarettes containing nicotine, also known as e-cigarettes, electronic nicotine delivery systems (ENDS) or e-cigs, are devices for making vapour for inhalation (vaping). E-cigarettes are considered by some health professionals as an option to help people quit smoking, although this view is strongly contested as the published evidence is mixed.

Proposed changes to access

On 23 September 2020 an interim decision was announced to clarify the regulation of e-cigarettes containing nicotine. If confirmed through a final decision, importing these products purchased from overseas internet sites without a valid prescription would be illegal. For more information see: Nicotine scheduling.

The interim decision on nicotine scheduling is a separate process from the Australian Government's proposed prohibition on the importation of e-cigarettes which has been deferred. For more information see: Update on nicotine scheduling and proposed restriction on importation of nicotine for use in e-cigarettes.

Information for consumers

To date, no e-cigarette products have been approved as smoking cessation aids in Australia. These products are considered to be 'unapproved' therapeutic goods and the TGA has not evaluated them for quality, safety and effectiveness.

E-cigarettes containing nicotine and nicotine for use in e-cigarettes to help a person to quit smoking can be prescribed by an Australian registered doctor and supplied with approval from the TGA. If you think these products may help you to quit smoking, you should speak to your doctor. If they believe it is the most appropriate treatment for your situation, they will be able to apply to the TGA for the necessary approval and help to arrange supply. Alternatively, you may be able to arrange to import these products under the personal importation scheme. For further information see: E-cigarettes.

There are registered (TGA-approved) smoking cessation medicines in Australia. These include nicotine replacement therapies (including sprays, patches, lozenges and chews) available without prescription either over-the-counter in pharmacies or in some cases from other retailers. There are also prescription medicines that can help you quit, as well as a range of non-medicine approaches to smoking cessation.

For help with quitting, talk to your health professional or phone the Quitline on 13 7848. Alternatively, visit the Quit Now website.

Information for health professionals

E-cigarettes containing nicotine and nicotine for use in vaporisers can be supplied under the Special Access Scheme (SAS) or the Authorised Prescriber Scheme, if you believe it is the most appropriate therapy for your patient.

Access pathways

Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, exported from or supplied in Australia unless otherwise the subject of an exemption, approval or authority under the Therapeutic Goods Act 1989.

To date, no e-cigarettes (including nicotine containing e- cigarettes) have been approved in Australia as a therapeutic good for smoking cessation. However, there may be circumstances where products that are not included in the ARTG (also referred to as 'unapproved medicines') may be appropriate. In these situations, there are a number of pathways through which Australian registered prescribers may access unapproved medicines on behalf of their patient(s):

Special Access Scheme

The SAS provides for the import and supply of an unapproved therapeutic good to a single patient on a case-by-case basis. SAS Category B may be used by prescribers to access liquid nicotine and nicotine-containing liquids for the purposes of smoking cessation.

Consistent with the requirements of SAS and in accordance with good medical practice, prescribers should consider appropriate approved treatment options that are included on the ARTG before considering accessing an unapproved e-cigarette product for a patient.

In addition, the prescriber, and the patient through informed consent take responsibility for any adverse consequences of treatment with the unapproved product.

Depending on the product, import restrictions and state and territory requirements may apply.  SAS approval does not override these requirements.

See the Special Access Scheme webpage and guidance material for further information.

The SAS Online System is the preferred method of submission to reduce processing times for applicants:

SAS Online System

SAS B forms are also available at:

How to access a pdf or Word document

Authorised Prescriber scheme

A doctor may be granted authority to become an 'Authorised Prescriber' of a specified unapproved therapeutic good (or class of unapproved therapeutic goods) to specific patients (or classes of recipients) with a particular medical condition. Once a doctor becomes an Authorised Prescriber, they do not need to notify the TGA each time they prescribe the unapproved medicine during the period of approval. However, they must report to the TGA the number of patients treated every six months. For information regarding the Authorised Prescriber scheme, please refer to the Authorised Prescriber Scheme Guidance for Medical Practitioners, Human Research Ethics Committees, Specialist Colleges and Sponsors.

Published guidance

State and territory requirements

Please note that state and territory governments have specific requirements regarding sale and possession of e-cigarette products. These differ between each state and territory. For further information, it is strongly recommended that you contact your local state/ territory health department prior to prescribing or travelling into Australia with e-cigarette products, to determine if there are any other restrictions on the possession and use of electronic cigarettes obtained with a medical prescription.

Reporting problems

The TGA has an important role in monitoring the safety of unapproved medicines and we strongly encourage consumers and health professionals to report any suspected adverse events involving e- cigarettes. Reporting adverse events helps us to build a profile of the safety of a medicine. Significant safety concerns are investigated as part of ensuring product safety in the Australian community.

Consumers and health professionals are encouraged to report problems with medicines using the TGA's online reporting system.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine.

Contact details for enquiries about the Special Access Scheme

If your enquiry is not about the SAS, see: Contact the TGA

Email: SAS@health.gov.au

Phone:

  • 1800 020 653
  • +61 2 6289 4632

Fax: +61 2 6203 1105

Post: SAS, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

Street address (for deliveries): Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia

Contact details for enquiries about Authorised Prescribers

If your enquiry is not about Authorised Prescribers, see: Contact the TGA

Email: authorised.prescribers@health.gov.au

Phone:

  • +61 2 6232 8911 (general application enquiries)
  • +61 2 6232 8866 (medicinal cannabis application enquiries)

Fax: +61 2 6232 8112

Post: The Medical Officer, Experimental Products Section, Pharmacovigilance and Special Access Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

Street address (for deliveries): Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia