There are currently no vapes for smoking cessation or the management of nicotine dependence included in the Australian Register of Therapeutic Goods (ARTG).
Therapeutic goods that are not included in the ARTG are known as unapproved therapeutic goods. These goods are not assessed by the TGA for quality, safety, or effectiveness.
There are established unapproved access pathways for registered medical practitioners, nurse practitioners and pharmacists to lawfully access unapproved vapes for patients under their care, if clinically appropriate.
Access pathways include:
- Special Access Scheme (SAS)
- Authorised Prescriber (AP) Scheme
- Clinical (CT) trial schemes
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all unapproved therapeutic goods and all products.
Special Access Scheme
Learn about and apply for the Special Access Scheme.
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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PageYou can access unapproved therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) in limited circumstances. You must speak to a health practitioner first.
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PageSummary of legal settings relevant to the prescribing and dispensing of therapeutic nicotine vaping goods to patients under 18 years of age.
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PageLearn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.
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PageLearn about the regulatory framework for prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
Authorised Prescriber Scheme
Learn how prescribers can apply to the Authorised Prescriber Scheme.
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PageYou can access unapproved therapeutic goods in certain circumstances. Find out who can apply, what you can access and what to do before you apply.
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ServiceAs a medical practitioner, you can apply to access an unapproved therapeutic good for a class of patients with the same condition.
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PageYou can access unapproved therapeutic goods that are not included in the Australian Register of Therapeutic Goods (ARTG) in limited circumstances. You must speak to a health practitioner first.
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PageThis infographic is a printable resource that can be used to communicate the streamlined approval process for medical practitioners.
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PageSummary of legal settings relevant to the prescribing and dispensing of therapeutic nicotine vaping goods to patients under 18 years of age.
-
PageLearn about how vapes for smoking cessation and nicotine dependence are regulated, and the requirements for dispensing and supplying vapes.
-
PageLearn about the regulatory framework for prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.