Since 2021, accessing NVPs has been legal only when dispensed by pharmacists to patients with a valid prescription. At the beginning of 2024, the TGA authorised NPs to prescribe NVPs under SAS-C. The Government and the TGA are currently updating the regulatory framework for NVPs, with legislative and regulatory changes to:
• Raise the minimum standards for prescribed NVPs;
• Improve patient access and streamline the prescribing and dispensing process; and
• Create enforcement powers sufficient to remove illicit vaping products from Australia’s high streets.
Practitioners will increasingly be required to provide patients with accurate information about therapeutic NVPs and, where appropriate, prescribe NVPs to their patients. It is vital to stay up to date with changes in the regulations and peak body guidance governing how you prescribe NVPs.
Access to NVPs under the TGA’s regulatory framework
NVPs have been subject to Therapeutic Goods regulations since 2021, when the TGA re-scheduled nicotine (except in preparations for oromucosal or transdermal administration) as a Schedule 4 (prescription-only) medicine. However, no NVPs are currently listed on the ARTG, and therefore the TGA has created new streamlined pathways to enable clinicians to prescribe NVPs as unapproved medicines.
As of 1 January 2024, the regulations permit prescribing and dispensing NVPs through any of the following special access pathways:
Authorised Prescriber (AP) Scheme
Medical practitioners may be preapproved by the TGA as APs to prescribe NVPs.
Almost all doctors are eligible for instant approval through the TGA’s SAS portal, from which they will receive an AP approval letter.
Doctors must ensure that their MAP number is included on prescriptions and that patients receive a copy of the approval letter.
Special Access Scheme B (SAS-B)
Where patients present with complicating factors (under 16, pregnancy, comorbidities), prescribers must seek TGA approval through the SAS-B pathway.
Prescribers must include the SAS-B Approval number on prescriptions and provide patients with a copy of the TGA Approval letter.
Special Access Scheme C (SAS-C)
Doctors and Nurse Practitioners may notify the TGA on a case-by-case basis and issue a prescription immediately without TGA approval.
Prescribers must include the SAS-C Notification number on the script and provide patients with a copy of the TGA Notification.
Australia’s standard for NVPs: TGO 110
Requirements Under TGO 110:
• Labelling;
• Packaging requirements;
• Prohibited ingredients;
• Permitted flavours (Tobacco, Menthol and Mint);
• Nicotine concentration limits; and
• Microbiological testing (TGO 100).
Further updates to TGO 110 (likely with effect from 1 Jan 2025):
• Maximum concentrations of certain flavouring ingredients;
• Device manufacturing quality requirements (ISO 13485); and
• Further nicotine concentration limits (maximum concentration and maximum treatment duration without further TGA approval).
NVPs and State-based tobacco regulations
NVPs supplied under prescription are medicines/medical devices, and are not considered to be ‘tobacco products’ under federal legislation.
However, there are some remaining conflicts between Federal and State/Territory laws in states that have not exempted NVPs. In these states, these conflicts typically relate to the sale or dispensing of NVPs and do not impinge upon a clinician’s ability to prescribe NVPs in line with typical good clinical practices.
Note: In the Northern Territory, NVP devices may only be dispensed under prescription. This is a mandatory legislative requirement. Clinicians must remember to include provision of the NVP device on any prescription for NVPs.
Updated RACGP Smoking Cessation Guidelines for NVPs
The Royal Australian College of General Practitioners (RACGP) has issued guidance to GPs on prescribing NVPs for therapeutic use:
• NVPs may be used as a second-line treatment, after a failed treatment attempt using a licensed pharmacotherapy;
• Recommended for short-term use of up to one year;
• Clinicians should prescribe closed-system NVPs to new users and, where possible, existing users;
• Where possible, GPs should ensure that patients access NVPs through brick-and-mortar pharmacies; and
• NVPs can be used in conjunction with other pharmacotherapies, including NRT.