G/TBT/N/AUS/128  
1 March 2021  
(21-1742) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Therapeutic Goods Administration, Department of Health  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if d ifferent from above:   
Department of Foreign Affairs and Trade  
Email: tbt.enquiry@dfat.gov.au  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  
Nicotine -containing products intended to be used in vaping devices such as e -cigarettes, 
e-cigars and other electronic nicotine delivery s ystems (ENDs).; TOBACCO AND 
MANUFACTURED TOBACCO SUBSTITUTES (HS 24); PHARMACEUTICAL PRODUCTS 
(HS 30) 
5. Title, number of pages and language(s) of the notified document:  Proposed new 
standard for unapproved vaporiser nicotine products - Therapeutic Goods (Standard for 
Vaporiser Nicotine) (TGO 110) Order 2021.  
6. Description of content:  The Therapeutic Goods Administration (TGA) is seeking 
comments on a proposed standard for vaporiser nicotine products.  
Vaporiser nicotine products are nicotine -containing p roducts intended to be used in vaping 
devices such as e -cigarettes, e -cigars and other electronic nicotine delivery systems 
(ENDs). This includes vape liquids, e -liquids and e -juices that contain nicotine and/or 
nicotine salts. This does not include other nicotine replacement therapies (NRTs) 
containing nicotine, such as patches, gum, lozenges, mouth spray and inhalators nor 
nicotine -containing products that are not intended for use in ENDs, such as chewing 
tobacco and snuff.  
The proposed standard relates only to unapproved goods – that is, medicines that have 
not been approved by the TGA and are not registered in the Australian Register of 
Therapeutic Goods (ARTG). While it is anticipated that a number of vaporiser nicotine 
products may seek approv al by the TGA as medicines in the coming years, it is also 
anticipated that there will be a significant number of prescriptions written for unapproved 
goods for smoking cessation.  
The proposed standard is in the form of a Therapeutic Goods Order (a TGO) an d would 
be TGO  110. TGOs are legal standards made under section 10 of the Therapeutic Goods 
Act 1989 (Act) which specify safety and quality rules for medicines imported into, 
exported from or supplied in Australia. TGOs can apply to approved or unapproved G/TBT/N/AUS/128  
 
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  products, or both, and may be limited to a certain type of medicine. TGOs cannot specify 
requirements for vaping devices.  
The public consultation on the Therapeutic Goods (Standard for Vaporiser Nicotine) 
(TGO 110) Order 2021 (draft TGO 110) is open until 31 March 2021, available via the link 
in section 8 below. We will review all feedback received and, if appropriate, revise the 
requirements in the draft TGO  110 before it is finalised.   
7. Objective and rationale, including the nature of urgent problems w here 
applicable:  The objectives of the new standard are to:  
• Assist in meeting the need for health practitioners and individuals to know what 
is in the product the person is inhaling for smoking cessation.  
• Minimise the risk of accidental exposure to and/or  ingestion of vaporiser nicotine 
products, particularly by young children.   
• Provide clarity for sponsors and manufacturers operating in multiple jurisdictions 
as to the minimum safety and quality requirements in Australia.  
Consumer information, labelling;  Protection of human health or safety; Quality 
requirements; Harmonization  
8. Relevant documents:   
• The proposed standard and consultation documents are available at : 
https://consultations.health.gov.au/tga/tgo110 -standard -for-vaporiser -
nicotine .  
9. Proposed date of adoption:  The standard is proposed to be finalised and published in 
April or May 2021 to allow enough time for stakeholders to become familiar with the 
requirements, and to organise procurement of compliant products, before the 
requirements come into effect on 1 October 2021.  
Proposed date of entry into force:  1 October 2021  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
The proposed standard and consultation documents are available at:  
https://consultations.health.gov.au/tga/tgo110 -standard -for-vaporiser -nicotine