From Friday 1 October 2021, consumers will no longer be able to buy nicotine vaping products from overseas websites without a valid doctor’s prescription.
AUTHORISED PRESCRIBER (AP) SCHEME
The Authorised Prescriber Scheme allows authorised medical practitioners to supply unapproved therapeutic goods (including nicotine vaping products) to a class of patients that medically require the products for the purposes of smoking cessation. Applicants must be registered as medical practitioners in their applicable state or territory jurisdiction.
Any registered medical practitioner may apply to become an Authorised Prescriber for nicotine products through the TGA.
Authorised Prescriber applications for nicotine vaping products must be made through the ‘Established history of use pathway’.
- Please note that Human Research Ethics Committee (HREC) approval or specialist college endorsement is not required before applying to the TGA.
- Prescribers will still be required to check their institutional requirements (e.g., if you work in a hospital, check with your hospital).
- Visit https://compliance.health.gov.au/sas/
- Login if you already have an account. If not, create a new user account by following the instructions on page 7 of the AP online system guide.
- Select ‘New Nicotine AP application’ from the ‘Authorised Prescriber Dashboard’.
- Review the pre-filled information regarding dosage form and indication.
- Read the privacy statement and if you agree, select ‘Yes’.
- Click the ‘Submit’ button.
Please note that the link provided is not an exhaustive list. The TGA has approved a total of 71 Authorised Prescribers across the country.
If you have completed your AP application (or you are already an authorised prescriber) and you wish to have your name and consultation address included on the public list, you should complete the list linked below and email it to email@example.com.
Please note that the names of prescribers can take up to a month to be published.
Authorised Prescribers must report the number of patients treated every 6 months. Use of the product must be reported twice yearly covering each period between 1 January to 30 June and 1 July to 31 December. Click here to find the Authorised Prescriber forms.
APPEALING AN APPROVALS DECISION
If you wish to appeal a TGA decision, you should make an informal appeal before you lodge a formal appeal.
To make an informal appeal, you should contact the delegate who evaluated your submission to discuss the matter.
If you are still unsatisfied with the outcome of your informal appeal, you can make a formal appeal:
- under section 60 of the Therapeutic Goods Act 1989
- to the Administrative Appeals Tribunal (AAT)
You must have attempted to appeal a decision under section 60 of the Therapeutic Goods Act 1989 before lodging an appeal with the AAT.
ADVERSE EVENT REPORTING
As nicotine vaping products are ‘unapproved therapeutic goods’, Authorise Prescribers are responsible for reporting any adverse events that may arise from the use of the goods under the Authorised Prescriber Scheme.
You must report any suspected adverse events or product defects related to the ‘unapproved good’ to the TGA within 15 calendar days becoming aware of the event. You are also required to report any fatal or life-threatening adverse drug reactions to the TGA within 7 calendar days after becoming aware of the information and follow up with a complete report (if necessary) within 8 additional calendar days.
PERSONAL IMPORTATION SCHEME
Patients may import their prescribed nicotine vaping products through the Personal Importation Scheme when purchasing from an overseas online retailer from Friday 1 October.
Patients will need to provide the overseas online retailer with a prescription from an Authorised Prescriber to legally purchase the goods. The patient will need to send their prescription from an authorised provider to the retailer and arrange for a copy of their prescription to be enclosed in the package.
Any registered medical practitioner in Australia who considers it appropriate for their patient to use nicotine vaping products for smoking cessation can prescribe these products for personal importation.
Medical practitioners do not need TGA authorisation or approval to prescribe unapproved nicotine vaping products for access through the Personal Importation Scheme.
Usually, authorised prescribers may not prescribe more than a three-month supply of nicotine vaping products in the one order and no more than 15 months’ supply in a 12 month period.
If your patient wishes to import more than a 3 months’ supply in one order, you will be required to apply to the TGA for approval via either the Special Access Scheme or the Authorised Prescriber Scheme to request the prescription.
- Nicotine vaping products that are bought overseas are subject to some (but not all) of the requirements under the new standard. Click here to see more about the nicotine vaping requirements under the Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110) Order 2021
- You may want to contact the overseas supplier to check if the product meets the regulatory requirements and has appropriate packaging, labelling, and manufacturing controls on behalf of your patient.
SPECIAL ACCESS SCHEME (SAS)
The SAS allows certain health practitioners to access unapproved therapeutic goods for a single patient.
SAS applications for nicotine products can be made through the SAS Category B application pathway. Category B applications need to be approved by the TGA before the nicotine vaping goods can be supplied to the patient.
- Make sure that you fill out the entire application and include all three patient identifiers, the patient diagnosis and indication, product details, and prescriber details.
- Prescribers will need to include a clinical justification for use of the nicotine vaping product in their application, which should summarise the following:
- Details of relevant past treatments and procedures, including reasons why any therapeutic goods that have been approved by the TGA may not be the most appropriate treatment under the circumstances.
- An appraisal of the expected clinical benefits versus the potential risks of the proposed treatment.
Click here to fill out an SAS Category B Form.
TEMPORARY MBS SERVICES FOR NICOTINE AND SMOKING CESSATION COUNSELLING
The Government has introduced 18 new temporary items relating to nicotine and smoking cessation into the Medicare Benefits Schedule (MBS). The new temporary items include six face-to-face, six telehealth and six phone services. These items are temporary and will be in place until 30 June 2022.
Nicotine vaping products are ‘unapproved therapeutic goods’, meaning that they are not currently registered under the Australian Register of Therapeutic Goods. However, there are still pathways to access these products.
Nicotine vaping products are a Schedule 4 medicine under the Poisons Standard. This means that using or supplying these products is available at pharmacies through a prescription only.
Selling nicotine vaping products to consumers without a prescription is illegal in Australia. The possession of these products without a prescription is also illegal (except in South Australia).
The new laws that require prescriptions for overseas purchases apply to the following products:
- nicotine e-cigarettes
- nicotine pods
- liquid nicotine
The new laws do not apply to the following products:
- nicotine replacement therapies (sprays, patches, lozenges, chews, and gums)
- vaping products that do not contain nicotine
THERAPEUTIC GOODS (STANDARD FOR NICOTINE VAPING PRODUCTS (TGO 110) ORDER 2021 (TGO 110)
The Therapeutic Goods Administration has introduced a new standard for unapproved and export only nicotine vaping products, which will take effect from Friday 1 October 2021. These standards outline the minimum safety and quality requirements for unapproved vaping products.
The TGO 110 sets a maximum nicotine concentration limit for unapproved nicotine vaping products of 100 mg/ML. Patients will not be able to access nicotine products that exceed this limit.
Note that compliance with these standards does not mean that nicotine vaping products will receive TGA approval.
ROYAL AUSTRALIAN COLLEGE OF GENERAL PRACTITIONERS (RACGP) GUIDE FOR HEALTH PROFESSIONALS
The RACGP has provided health practitioners with an information toolkit on prescribing nicotine vaping products. It seeks to assist health professions in the implementation of evidence-based strategies that the success rates of patients in their smoking cessation efforts.
The guideline highlights four key recommendations for health professionals:
- All patients who smoke should be offered advice about quitting smoking.
- A system for identifying all people who smoke and documenting tobacco use should be used in each practice and healthcare service.
- Smoking cessation advice should be offered in routine consultations and appointments, whenever possible.
- Offer follow-ups to all patients who are trying to quit smoking.
The Guide also provides information on:
- The scope of the tobacco smoking problem in Australia
- Harms associated with smoking
- The effectiveness of treating tobacco dependence
- The role of health professionals in smoking cessation
- Tobacco dependence