G/TBT/N/AUS/151/Add.2  
 
26 April 2024  
(24-3430) Page: 1/3 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  26 April 2024, 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:   
[X] Notified measure adopted - date: 14 December 2023  
[ ] Notified measure published - date:  
[X] Notified measure enters into force - date: 1 January 2024  
[X] Text of final measure available from1:  
Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023, available at: 
https://www.legislation.gov.au/F2023L01667/latest/text  
Customs Legislation Amendment (Vaping Goods) Regulations 2023, available at: 
https://www.legislation.gov.au/F2023L01666/latest/text  
Therapeutic Goods (Excluded Goods) Amendment (Vaping) Determination 2023, 
available at: https://www.legislation.gov.au/F2023L01684/latest/text  
Therapeutic Goods (Articles that are Not Medical Devices) Amendment (Vaping) 
Declaration2023, available at: https://www.legislation.gov.au/F2023L01682/latest/text  
Therapeutic Goods (Medical Devices —Specified Articles) Amendment (Vaping) 
Instrument 2 023, available at: https://www.legislation.gov.au/F2023L01681/latest/text  
Therapeutic Goods (Standard for Nicotine Vaping Products) (TGO 110 ) Amendment 
(Vaping) Order 2023, available at: 
https://www.legislation.gov.au/F2023L01680/latest/text  
Therapeutic Goods (Medical Device Stan dard—Therapeutic Vaping Devices) Order 2023, 
available at: https://www.legislation.gov.au/F2023L01686/latest/text  
Therapeutic Goods (Informa tion Specification —Therapeutic Vaping Goods and Vaping 
Devices) Instrument 2023, available at: 
https://www.legislation.gov.au/F2023L01685/latest/text  
Customs (Prohibited Imports) (Vaping Goods) Approval 2023, available at: 
https://www.legislation.gov.au/F2023L01743/latest/text  
 
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.2  
 
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  Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Bill 2024, 
available at: 
https://www.aph.gov.au/Parliamentary_B usiness/Bills_Legislation/Bills_Search_Results
/Result?bId=r7169  
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[ ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  Proposed reforms to the regulation of Electronic Nicotine Delivery systems (ENDs) and 
Electronic Non -Nicotine Delivery systems (ENNDs) notified in G/TBT/N/AUS/151 and 
G/TBT/N/AUS/151.add1 are being implemented in 2024.  
Adopted reforms include  implementing changes to Australia's borders to restrict the importation of 
vapes. From 1 January 2024, the importation of all single use disposable vapes is prohibited, subject 
to very limited exceptions.  
Additionally, from 1 March 2024:  
• importation of al l vapes without an import licence and permit from the Office of Drug Control 
is prohibited, subject to limited exceptions.  
• to obtain an import permit, importers are required to notify the Therapeutic Goods 
Administration (TGA) that a vape is:  
o only for smok ing cessation or the management of nicotine dependence, and that the 
vape complies with relevant product standards (Australian manufacturers must also 
make a notification to that effect before first releasing vapes for supply); or  
o a vaping device that is o nly for use with medicinal cannabis, and the device complies 
with the essential principles in the Therapeutic Goods (Medical Devices) Regulations 
2002 (the pre -existing requirement to obtain an import permit for vaping substances 
containing cannabis has no t changed).  
• the standard that previously only applied to nicotine vapes applies to all therapeutic vapes 
for smoking cessation and the management of nicotine dependence, irrespective of nicotine 
content. New flavour restrictions have also been added to thi s standard.  
• vaping devices that are not exclusively for the administration of a medicine are no longer 
excluded from the therapeutic goods regulatory framework. A new medical device standard 
applies to these devices as an alternative to essential principle s that ordinarily apply to 
medical devices.  
• individuals are no longer able to access the personal importation scheme to import 
therapeutic vapes for personal use, apart from a limited exemption for travellers to Australia 
under which modest quantities are permitted.  
The updated minimum quality and safety standard, which applies to both ENDS and ENNDS for 
smoking cessation or the management of nicotine dependence, includes requirements for:  
• product labelling (including an over sticker or in an information sheet provided with the 
product)  
• child resistant packaging  
• requirement for the product label to list all active ingredients and state the nicotine 
concentration of the vape  
• prohibited ingredients  
• limited flavours permitted (mint, menthol and to bacco only)  
• quality management system requirements for vaping devices and vaping device accessories 
that do not comply with the essential principles that ordinarily apply to medical devices  G/TBT/N/AUS/151/Add.2  
 
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  • documentation that needs to be kept by the Australian sponsor of t he product demonstrating 
compliance with the requirements of the minimum quality and safety standards.  
The new medical device standard provides minimum certification requirements for therapeutic 
vaping devices and therapeutic vaping device accessories that  were excluded goods as 1 January 
2024.  
Other proposed measures that have been previously notified in G/TBT/N/AUS/151 and 
G/TBT/N/AUS/151.add1 are also being pursued. On 21 March 2024, the Australian Government 
introduced the Therapeutic Goods and Other Le gislation Amendment (Vaping Reforms) Bill 2024 into 
the Parliament of Australia. The Bill proposes strict domestic controls on all vaping goods. It proposes 
prohibiting the importation, domestic manufacture, supply, commercial possession, and 
advertisement  of single use disposable vapes and non -therapeutic vaping goods. Therapeutic vaping 
goods will continue to be available and subject to regulation under the Therapeutic Goods Act 1989,  
in line with other medicines and therapeutic goods.  
Further details abo ut the reforms is available at: Vaping hub | Therapeutic Goods Administration 
(TGA)  
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