An overview of therapeutic vaping goods

Generally, any product which claims to have, or has, a therapeutic use must be authorised by us for that purpose by being listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

There are currently no vapes for smoking cessation or the management of nicotine dependence included in the ARTG. They have not been evaluated by us for safety, quality, or efficacy.

You must understand how we regulate unapproved therapeutic vaping goods and your obligations as a sponsor. You must also comply with:

• Office of Drug Control - external site licence and import requirements
• quality and safety standards, including medical device standards
• notification of compliance requirements to the TGA prior to importing or supplying a vaping product
• good manufacturing practice requirements
• strict advertising restrictions. 

Being well-prepared helps ensure lawful supply and avoids regulatory delays.

Start by learning about your responsibilities for either inclusion in the ARTG or the notification of compliance pathway. 

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.