Notified vape list: goods for smoking cessation or nicotine dependence

About the notified vape list: therapeutic vaping goods for smoking cessation or nicotine dependence

The notified vape list specifies therapeutic vaping goods that may be prescribed and supplied for smoking cessation or the management of nicotine dependence in Australia. 

Note that these ‘notified vaping goods’ are not approved therapeutic goods on the Australian Register of Therapeutic Goods, and have not been assessed by the TGA for quality, safety and efficacy or performance.

For a product to be included in the notified vape list, product sponsors must notify the TGA that their good complies with minimum requirements for notified vaping goods,  such as product standards Therapeutic Goods (Standard for Therapeutic Vaping Goods) (TGO 110) Order 2021 and Therapeutic Goods (Medical Device Standard - Therapeutic Vaping Devices) Order 2023 (MDSO).

Compliance with regulatory standards

Product information has been self-declared by sponsors and the TGA cannot guarantee and assumes no legal liability or responsibility for the accuracy, currency, completeness or interpretation of the product information provided in the notified vape list. It is an offence to provide false or misleading information to a government agency.

The TGA conducts compliance assessments as part of ongoing compliance monitoring for these products.  

Providing a notice for a therapeutic vaping good, which does not meet the requirement for the framework, can result in civil and criminal penalties under the Therapeutic Goods Act 1989. 

Information for prescribers and pharmacists

Prescribers and pharmacists involved in prescribing, dispensing and supply of unapproved therapeutic vaping products must comply with both Commonwealth and state/territory legislation. 

Prescribers and pharmacists must only supply products in their final dosage form (finished product) directly to a patient. 

On 19 June 2025, the TGA published a statement regarding new standards for nicotine vaping products from July 2025, which contains additional information for pharmacists ahead of 1 July 2025. 

Inclusion in the list does not guarantee the product is available.

The TGA is unable to provide advice in relation to specific products in these lists and recommends contacting the relevant sponsor.