From 1 October 2021, consumers must present a valid prescription from an Australian medical practitioner for all purchases of nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine. This includes products dispensed in Australia and imported by the patient directly from overseas.
Nicotine vaping products are not recognised as a safe and effective aid to smoking cessation. However, for long-term smokers who have tried to achieve smoking cessation with approved pharmacotherapies but failed, and who are still motivated to quit smoking and have discussed e-cigarette use with their healthcare practitioner, some doctors may in some cases find it reasonable to recommend use of nicotine vaping products. Refer to the RACGP guidelines.
Further resources can be found on the TGA website Nicotine e-cigarettes hub.
From 1 October 2021, a prescription is required for the supply of nicotine e-cigarettes and other nicotine vaping products for any purpose, including importing from overseas online retailers. All nicotine for human use is a Schedule 4 (prescription only) medicine (other than in tobacco for smoking and in registered medicines for transdermal or oromucosal use, i.e. nicotine replacement therapy).
The TGA has not approved any nicotine vaping products for supply in Australia. Where a doctor considers nicotine vaping products a clinically appropriate aid to smoking cessation, a valid prescription can be provided via one of three pathways.
For nicotine vaping products to be dispensed in a pharmacy, the prescriber must have either:
For a patient to access nicotine vaping products from overseas via the Personal Importation Scheme the patient requires a valid prescription from an Australian registered doctor, no TGA approval is needed. Patients are not permitted to import more than 3 months supply at a time. As with all scheduled medicines, the choice of whether to prescribe them is up to the prescriber, and they must not be prescribed merely because a patient requests them, nor in a quantity, or for a purpose, which does not accord with the recognised therapeutic standard for the medicine. Nicotine vaping products must not be supplied to persons aged under 18 years, or for recreational use.
From 1 October 2021, all nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, are Schedule 4 (prescription only) medicines.
A pharmacy must be registered with NSW Health to be able to supply nicotine vaping products. Registration is through the Service NSW website.
Vaping products (even those containing no nicotine) can not be supplied to or for anyone aged under 18 years (even on prescription).
Nicotine vaping products and associated devices and accessories must not be visible to the public from inside or outside the premises, and can be sold from only one point of sale (cash register). They cannot be included in any shopper loyalty program.
A prescription valid in NSW is required to supply nicotine vaping products. The prescription must be written by an Australian registered medical practitioner, and the prescription can be dispensed only if the pharmacist is satisfied that the prescriber holds an Authorised Prescriber (AP) approval or Special Access Scheme (SAS) Category B approval for the medicine prescribed to that patient.
Pharmacies may obtain unapproved nicotine vaping products prior to receiving a prescription, only for the purpose of dispensing genuinely anticipated prescriptions issued by an Authorised Prescriber or under a Special Access Scheme approval.
Unapproved nicotine vaping products must comply with Therapeutic Goods Order no. 110 and may be sourced:
The pharmacy must provide its tobacco product Retailer Identification Number (RIN) to the wholesaler when requesting supply of any vaping product or accessory.
For further information see Information for Pharmacists - Nicotine Vaping Products and the TGA website Nicotine vaping products: Information for pharmacists
As with all Schedule 4 medicines, nicotine vaping products:
Nicotine vaping products must be supplied in containers with a Child Resistant Closure conforming to the Poisons Standard (the SUSMP) and the Regulation.
A nicotine product may be extemporaneously compounded only in accordance with a prescription issued for an individual patient in accordance with a TGA Authorised Prescriber or SAS Category B approval. Compounding must be conducted in accordance with the Pharmacy Board of Australia Guidelines on compounding of medicinesA compounded medicine can be prepared only in circumstances where a similar commercially available finished product medicine is unavailable, or clinically unsuitable for that patient.
The pharmacist must also ensure the compounded product is compliant with the Commonwealth's Therapeutic Goods Order 110 (TGO 110). See the TGA website for further information.
Wholesalers of nicotine vaping products must hold a licence to supply by wholesale, a restricted substance for therapeutic use. See Licences and authorisations.
The wholesaler must obtain the pharmacy’s Retailer Identification Number (RIN) before supplying any vaping product or accessory.
