G/TBT/N/AUS/151/Add.1  
 
11 September 2023  
(23-6006) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  11 September 2023, is being circulated at the request of the 
delegation of Australia . 
 
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Title:  Potential reforms to the regulation of nicotine vaping products - consultation paper  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[ ] Notified measure published - date:  
[ ] Notified measure enters into force - date:  
[ ] Text of final measure available from1:  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[X] Content or scope of notified measure changed  and text available from1:  
https://www.health.gov.au/ministers/the -hon-mark-butler -mp/media/taking -action -
on-smoking -and-vaping?language=en  
New deadline for comments (if applicable):  60 days from notification  
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  In notification G/TBT/N/AUS/151, it was advised that Australia is considering potential 
reforms primarily to the regulation of Electronic Nicotine Delivery Systems (ENDs). The scope of the 
proposed reforms has expanded to cover all vapes, including electronic non -nicotine delivery 
systems (ENNDs).  
The proposed reforms to ENDs previously notified are still being pursued. However, subject to further 
consultation, it is now intended that all vapes (both e -liquids a nd devices used to produce vapour) 
will be prohibited unless they are therapeutic products to be used for smoking cessation or to treat 
nicotine addiction in accordance with Australia's therapeutic goods legislation. It is also intended to 
prohibit all sin gle use disposable vapes.  
It is proposed that this would involve:  
• Making changes to Australia's border controls to:  
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/AUS/151/Add.1  
 
- 2 - 
 
  o Prohibit the importation of all single use disposable vapes;  
o Prohibit the importation of all other vapes without an import permit. Permits would 
only be granted for therapeutic vapes (mainly ENDs) that comply with Therapeutic 
Goods Administration (TGA) requirements, including new pre -market requirements 
and a strengthened product standard regarding minimum quality and safety 
standards ; and  
o Restrict individuals from importing therapeutic vapes for personal use under the 
Personal Importation Scheme.  
• Implementing equivalent restrictions on the manufacture and supply of vapes within 
Australia. It would only be permissible to manufacture an d supply therapeutic vapes that 
comply with TGA requirements.  
• Ensuring therapeutic vapes are only available for the purpose of smoking cessation or to 
treat nicotine addiction with a doctor's prescription (which is largely the current position).  
The object ives of, and rationale for, the proposal outlined in G/TBT/N/AUS/151 also apply to the 
broader proposal. Due to the health risks of vapes and the escalating use of vapes by young people, 
it is considered necessary to strictly control access to circumstance s where a medical professional 
has assessed the need for the product (mainly for smoking cessation but also possibly to treat 
nicotine addiction if clinically appropriate). It is also considered necessary to impose quality 
standards to mitigate the health risks for lawful users and reduce the attractiveness of vapes to 
children and adolescents.  
The original consultation paper is available at the following link: 
https://consultations.tga.gov.au/medicines -regulation -division/proposed -reforms -to-the-
regulation -of-nicotine -vap/. A further consultation paper will be available before 11 September 2023 
at: https://consultations.tga.gov.au/medicines -regulation -division/df36e4a0 .  
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