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28 Dec. 2023

Reforms to the regulation of vapes - January 1

Reforms to the regulation of vapes will seek to address the significant public health issues caused by vaping, particularly among young people.

From 1 January 2024:

  • the importation of all disposable vapes will be banned, with very limited exceptions.
  • the Special Access Scheme C (SAS C) pathway, will be extended to facilitate legitimate patient access to therapeutic vapes, for smoking cessation and the management of nicotine dependence.
  • a form will be available for importers and manufacturers of therapeutic vapes to notify the TGA about compliance with the relevant product standards prior to importation into Australia or release for supply for those vapes manufactured domestically (notifications are required from 1 March 2024),
  • an application form will be available for therapeutic vape importers to apply for licences and permits for importing therapeutic vapes (licences and permits will be required from 1 March 2024),

From 1 March 2024 there will be: 

  • a ban on the importation of all vapes without an import licence and permit from the Office of Drug Control- external site,
  • a requirement for therapeutic vape importers and manufacturers to notify the TGA about compliance with the relevant product standards before importation to Australia or release for supply in Australia,
  • closure of the Personal Importation Scheme for vapes
  • an exemption for travellers bringing a small quantity of vapes into Australia
  • some changes to the quality requirements for therapeutic vapes for smoking cessation and the management of nicotine dependence, including restrictions on flavours to mint, menthol and tobacco,
  • a new medical device standard for therapeutic vaping devices that were previously excluded from the therapeutic goods framework.

These changes are being implemented through therapeutic goods and customs legislation.

A webinar will be held on 17 January by the TGA to address these changes, please register here.

Learn how patients can access vapes after 1 January 2024, where their doctor considers that it is appropriate for smoking cessation or the management of nicotine dependence.