The regulatory framework governing access to NVPs
Since 2021, accessing NVPs is only legal when dispensed by pharmacists to patients with a valid prescription.
The government and the TGA are currently updating the access framework for NVPs with legislative and regulatory changes to:
• Raise the minimum standards for prescribed NVPs;
• Improve access and streamline the prescribing and dispensing process; and
• Provide strong enforcement measures to remove illicit vaping products from Australia’s high streets.
Pharmacists will increasingly be asked to give patients accurate information on accessing prescribed NVPs and to dispense high-quality NVPs. As such, pharmacists must remain up to date with regulatory changes.
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 pathways:
Authorised Prescriber (AP) Scheme
GPs are pre-approved by the TGA to prescribe nicotine.
The script must note the prescriber’s MAP number and a copy of the TGA Authorisation letter must be provided with the script.
Special Access Scheme B (SAS-B)
Used to seek TGA approval to supply NVPs to patients who have presented with complicating factors (below 16,
pregnancy, comorbidities).
The script must note the SAS-B Approval number and a copy of the TGA Approval letter must be provided with the script.
Special Access Scheme C (SAS-C)
A notification process for prescribing NVPs on a case-by-case basis, available to GPs and Nurse Practitioners.
The script must note the SAS-C Notification number and a copy of the TGA Notification must be provided with the script.
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, the onus is on the pharmacy channel to liaise directly with State authorities to ensure compliance with State-based regulations.
The TGA’s guidance highlights potential conflicts with State and Territory tobacco legislation, which pharmacists should be aware of.
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.
Holding stock
Historically, under the Special Access pathways, pharmacies could only arrange for the supply of unapproved therapeutic goods once they had been provided with an authorisation letter under which the unlicensed medicine was prescribed.
Schedule 5A (Item 15) of the Therapeutic Goods Regulations allows registered pharmacists to hold NVPs in stock in anticipation of supplying patients under one of the Special Access pathways.
Liber:Onboard
Whitney Kabel
Head of Medical Liaison
- external link (hubspot.com)
Liber:Activate
- external link (liber.com.au)
This content is gated for Australian healthcare professionals only
This website is a source of educational content for Australian-registered healthcare professionals only. You must not use the content for any other purpose. If you are a patient seeking medical advice please see your healthcare professional.
By accessing this website you are agreeing that you are an Australian-registered healthcare professional with a current AHPRA registration and are entitled to access this content. Your use of this content is also subject to our Terms of Use and Privacy Policy.