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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.