Nicotine webinars: Frequently asked questions (FAQ)
A wholesaler licence must be obtained from the relevant State or Territory health department as requirements are governed by State and Territory legislation. The contact details for the State and Territory medicines regulation units are available on the TGA website.
Applicants for a wholesale licence must meet a number of requirements, including demonstrating that they are a fit and proper person and that the premises are suitable for wholesale purposes.
The TGA publishes the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 (Wholesale Code), which is implemented through the States and Territories.
The Wholesale Code is applicable to wholesalers, who are defined as persons or organisations, including manufacturers, wholesalers, manufacturer's agents, importers and distributors who store and/or supply wholesale prescription and pharmacy medicines (substances in Schedules 2, 3, 4 and 8).
The interim decision does not propose restrictions on the amount or concentration of nicotine contained in the liquid preparation. Any submissions provided through the consultation about the supply of highly concentrated preparations of liquid nicotine would be considered by the Delegate in reaching a final decision.
No. Vape shops are currently not legally allowed to sell liquid nicotine. This will not change if the interim decision is made final. This is because prescription medicines can only be supplied by pharmacies dispensing a prescription.
The usual prescription medicines registration process apply. A submission to register a prescription medicine consists of:
- data that support the quality, safety and efficacy of the product for its intended use. Evidence for efficacy and safety would be required to come from clinical trials,
- completed forms, and
- the payment of fees.
The TGA also offers a dedicated service to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations. Visit the TGA website to find out more information on how the SME Assist team can help you.
Yes. Many pharmacies already provide a service supplying prescription medicines through the mail, subject to the presentation of evidence of a prescription. More information is available at the Pharmacy Board Guideline for Dispensing of Medicines.
Patients ordering prescription medicines through the personal importation scheme usually hold the original prescription and provide a copy of the prescription to the supplier. If the decision is made final, the TGA will publish information to promote consumers and supplier awareness on the requirements of the personal importation scheme.
Electronic vaping devices or Electronic Nicotine Delivery Systems (ENDS) are not controlled as medical devices. Therefore, they fall outside the legal coverage of the TGA.
The Australian Competition and Consumer Commission (ACCC), under Australian Consumer Law, is responsible for investigating safety and performance issues associated with electronic vaping device products.
No specific standards were proposed in the interim decision, although if submissions are made around standards in response to the interim decision the delegate would consider these in reaching a final decision. Nicotine e-cigarettes could be sourced from countries that have product safety and quality standards for these products. For example, the New Zealand parliament passed legislation, which comes into force on 11 November 2020, that would mean importers or manufacturers are responsible for ensuring that products meet product safety requirements. New Zealand is instituting a searchable database, which will be available to support local wholesalers and retailers to meet the new requirements. Several other countries, such as the UK have also introduced a range of product standards.
Note: There are currently, no nicotine e-cigarettes entered on the Australian Register of Therapeutic Goods (ARTG). The TGA cannot guarantee the quality, safety or efficacy of unapproved products.
Yes. If the decision is made final, information will be published on the TGA website to help suppliers and pharmaceutical wholesalers understand how to lawfully supply nicotine e-cigarettes.
No. The Special Access Scheme B (SAS-B), Authorised Prescriber and Personal Importation Schemes are only available for medical use.
It is recognised that different individuals may take differing lengths of time to give up smoking, and thus be prescribed e-cigarettes for different periods. The discussion on nicotine e-cigarettes for harm reduction on the pathway to smoking cessation is a matter for a doctor and an individual patient.
There is ongoing debate about a potential role for e-cigarettes in harm reduction. The Royal Australian College of General Practitioners (RACGP) Supporting smoking cessation: A guide for health professionals, nicotine-containing e-cigarettes have a potential role as a tobacco harm reduction strategy.
You can ask your regular doctor to recommend another doctor willing to prescribe containing e-cigarettes to help you quit smoking.
If the interim decision is made final, there will be extensive communication of the changes and the publication of prescribing information for doctors to facilitate the discussion between doctors and patients.
The decision to bulk bill is at the discretion of the doctor. Some doctors may choose to charge an out of pocket fee for the consultation.
The main difference is that once a doctor becomes an Authorised Prescriber (AP), they do not need to notify the TGA each time they prescribe nicotine e-cigarettes for smoking cessation. Medical practitioners able to use the Authorised Prescriber scheme to prescribe nicotine as an aid to stop smoking - without requirement for ethics committee approval. For the five year duration of the approval no further applications or permissions are required. Application is free of charge and only the prescriber's name and AHPRA number is required to be filled into a simple online form which will be available on the TGA website, if the decision is made final.
The Special Access Scheme B (SAS-B) are approved on an individual patient basis, which means that a separate application needs to be submitted to the TGA for each patient.
Yes. A doctor may write a script for a single patient to access to nicotine e-cigarettes through the personal importation scheme. If you wish to bring in more than 3 months' supply at the one time into Australia, an Australia-registered doctor will first need to apply to the TGA for approval to use through the Special Access Scheme B (SAS-B) or to become an Authorised Prescriber using the forms available on the TGA website.
Currently, no specific standards are proposed, although it is possible that some submissions proposing particular standards may be made in response to the interim decision. E-cigarettes could be sourced from countries such as the UK and NZ that have product safety and quality standards for these products. New Zealand is instituting a searchable database which will be available to support local wholesalers and retailers to meet the new requirements.
Note: There are currently, no nicotine e-cigarettes entered on the Australian Register of Therapeutic Goods (ARTG).
Patients with mental illnesses would continue to be able to access nicotine e-cigarettes with a prescription. The doctor in consultation with a patient will make a decision on whether it is clinically appropriate to prescribe nicotine e-cigarettes.
In recognition of the disproportionately high smoking prevalence and low quit rates among people living with mental health illnesses, the Royal Australian and New Zealand College of Psychiatrists supports the legalisation and regulation of nicotine-containing e-cigarettes and other vaporised nicotine products to facilitate their use as harm reduction tools.
Yes. The doctor in consultation with a patient will make a decision on the period to prescribe nicotine e-cigarettes that is clinically appropriate and when a follow up consultation should be scheduled.
Use of nicotine and other regulatory approaches
There is increasing evidence that youth who use e-cigarettes are more likely to take up smoking. On 30 September 2020, the National Centre for Epidemiology and Population Health at the Australian National University published a Summary report on use of e-cigarettes and relation to tobacco smoking uptake and cessation, relevant to the Australian context. The report reviewed over 20 significant published studies and found that among people who have never smoked or are current non-smokers, those who use e-cigarettes are, on average, around three times more likely to take up smoking of combustible cigarettes than those who have not used e-cigarettes, and that former smokers who use e-cigarettes are more likely to relapse than current smokers
More recently, the Irish Health Research Board, on 12 October 2020, published a report which had very similar finding demonstrating that teenagers are between three and five times more likely to start smoking if they have used e-cigarettes previously.
There is evidence that nicotine use (from smoking or from use of e-cigarettes) can harm the human adolescent brain. Nicotine can impact the development of the of the parts of the brain that control attention, learning, mood and impulse control.,,
Although it is likely that vaping is safer than smoking cigarettes, the asserted figure of 95% safer is widely contested. The '95% safer' claim emerged from the findings in July 2013 of a group of 12 researchers rating the relative harm of 12 nicotine-containing products by 14 criteria concerned with harm to users and to others. The authors themselves acknowledged the absence of hard evidence for the harms of most of the products.
As nicotine e-cigarettes have only been on the market for a short time compared with combustible tobacco, and are continually changing, their long-term safety and health effects are unknown with long-term follow-up being limited and the overall number of studies small. The TGA has no regulatory remit over nicotine in tobacco prepared for smoking.
There are a number of differences between nicotine replacement therapies (NRT) such as sprays, patches, inhalators and gums compared to nicotine e-cigarettes. These NRT products deliver nicotine to the body through the lining of the mouth and cheeks (sprays, inhalator, gums and lozenges) or the skin (patches). Importantly, they are designed to reduce nicotine withdrawal and cravings while minimising the potential for abuse when compared with e-cigarettes that deliver rapid boluses of nicotine to the lungs. So-called "inhalers" do not deliver nicotine to the lower respiratory system in the same manner as e-cigarettes.
The safety, quality and efficacy of NRT in these sprays, patches, inhalators and gums have been assessed by the TGA and determined that they can be sold in retail outlets with reasonable safety.
Snus, snuff and chewing tobacco would be Schedule 4 medicines, unless they meet the existing exemption for smoking cessation preparations for oromucosal or transdermal administration., which would continue to apply.
No restrictions on flavours or strengths have been proposed in the delegate's interim decision. Depending on a smoker's pattern of use of cigarettes, they may require different strengths of liquid nicotine and would self-titrate the dose.
Nicotine is highly addictive. International experience has shown that the increasing uptake of nicotine e-cigarette use in youth is of concern and there is strong evidence that it is a gateway to smoking., There has been significantly increasing use of nicotine e-cigarettes by youth among Australians aged 15-24 - 4.5 % are current e-cig users in 2019 up from 2.3 % in 2016. Use has increased to significantly higher levels in North America. For example in US High Schools - 27.5 % are current e-cigarette user in 2019 (up from 11.7% in 2017) and among Canadians aged 15-19 - 15 % are current e-cigarette users in 2019 (up from 6% in 2017).
In Australia, we have an opportunity to prevent the uptake of nicotine e-cigarettes in youth while still providing a means for adults to use these products to stop smoking. The Delegate's interim decision is intended to strike a balance between protecting young people from the risks with using nicotine containing e-cigarettes and access to e-cigarettes to assist smokers to quit on the advice of their doctor.
Vape shops are currently not legally allowed to sell liquid nicotine under State and Territory legislation. This would not change if the interim decision is made final.
Currently, nicotine in e-cigarettes for therapeutic use are already a prescription-only medicine (Schedule 4). The interim decision, if made final, would make it clear that nicotine e-cigarettes for any human use are captured by Schedule 4 and give Australian Border Force (Customs) unequivocal powers to stop black market imports.
The TGA will work with the Customs to agree on priority targets of unlawful imports. The TGA laboratories are able to test liquids for the presence of nicotine.
Impact on cost
The cost of products would be determined by suppliers. There may be cost savings for consumers when suppliers import in bulk as the shipping costs can be spread over a larger amount of goods.
Not for unauthorised medicines. Products that are not entered on the Australian Register of Therapeutic Goods ('unapproved medicines') cannot be listed on the Pharmaceutical Benefits Scheme (PBS). It is anticipated that in the next few years some companies will apply for registration of nicotine e-cigarette products with the TGA. If the products received TGA approval, they are eligible for consideration for reimbursement through the PBS.
You can make a submission at our consultation hub.
Yes. If the interim decision is made final, a transition period is expected when information will be published on the TGA website to help consumers and health practitioners understand the regulatory requirements. The TGA would also undertake a broader range of public communication activities through social and mass media and consumer and healthcare professional organisations at that time.
A reduction in the number of young Australians taking up vaping and increased numbers of smokers successfully quitting with support from their doctor.