  
  
G/TBT/N/AUS/125  
19 October 2020  
(20-7199) Page: 1/3 
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:  Department of Health (Therapeutic Goods Administration)  
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  different from above:   
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 other than specified nicotine replacement therapies and nicotine 
prepared and packed for smoking.  
5. Title, number of pages and language(s) of the not ified document:  Notice of an 
interim decision to amend the current Poisons Standard (20 page(s), in English)  
6. Description of content:  The document available at the first link at 8. explains the 
Delegate's interim decision (nicotine (other than in specif ied products) for all human use 
is included in the instrument which regulates poisons in Australia, the Poisons Standard, 
as a schedule 4 substance so that it may only lawfully be supplied in accordance with a 
medical practitioner's prescription) and the r easons for it addressing the requirements 
imposed on the Delegate by the Therapeutic Goods Act 1989 (Cth). The interim decision 
is open for public consultation before the Delegate makes a final decision, taking account 
of all submissions received from the public on or before the closing date, 6 November 
2020.  
By way of short background, the regulation of nicotine containing e -cigarettes is a shared 
responsibility between the Commonwealth and state and territory governments:   
• The Poisons Standard regulates substances including nicotine; it is a legislative 
instrument made in accordance with the recommendation of a senior medical 
officer acting as the delegate of the Secretary of the Department of Health. Each 
decision is must b e made in accordance with the requirements of the 
Therapeutic Goods Act 1989  including the Scheduling Policy Framework for 
Medicines an d Chemicals  endorsed by the Australian Health Ministers Advisory 
Council.  
• The Poisons Standard consists of decisions regarding the classification of 
medicines and poisons into Schedules for inclusion in the relevant legislation of 
the States and Territorie s; the Poisons Standard has no effect under the law of 
the Commonwealth. The Poisons Standard also includes model provisions about 
containers and labels, a list of products recommended to be exempt from these 
provisions, and recommendations about other con trols on drugs and poisons. G/TBT/N/AUS/125  
 
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  The Poisons Standard is the legal title of the Standard for the Uniform 
Scheduling of Medicines and Poisons (SUSMP).  
The documents available at the second link at 8. explain the implications of the Delegate's 
interim decision if  it were to be made final. There is information for consumers, medical 
practitioners and pharmacists. There are flow diagrams demonstrating the impact on the 
supply chain if the interim decision is made final.  
In sum, the interim decision would have the ef fect that nicotine containing e -cigarettes 
along with other nicotine containing products not expressly excluded from the decision 
(nicotine replacement therapies and in tobacco prepared and packed for smoking) would 
be a medicine which would only be availa ble on prescription from a medical practitioner. 
That is, commercially  imported e -cigarettes containing nicotine and other affected 
products could only be supplied following importation if there is a medical practitioner's 
prescription. Because there is pr esently no e -cigarette containing nicotine entered on the 
Australian Register of Therapeutic Goods (established and maintained under the 
Therapeutic Goods Act) the goods are lawfully imported:  
• commercially  if they are stored in a warehouse 'under lock and key' before 
being distributed under a state or territory licence and in accordance with an 
approval or an authority given under the Therapeutic Goods Act and in 
accordance with a medical practitioner's prescription  
• by individuals  for their own or their imm ediate families use in accordance with a 
medical practitioner's prescription up to a maximum three months' supply at 
any one time and 15 months' supply over a 12 month period.  
The Delegate is specifically inviting submissions on whether to include a requir ement for 
child resistant closures for liquid nicotine products.  
The Delegate's reasons set out how the proposed measure addresses the objectives 
specified at no. 7.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
1. The objectives of the Delegate's interim decision are to:  
1. arrest the recent rapid increase in use of nicotine containing e -cigarettes 
by adolescents and young adults;  
2. provide to patients who want to stop smoking efficacious support, not 
already available (such as the Quit program) - likely in the form of 
medical practitioner support, including considering whether to prescribe 
nicotine containing cigarettes  
3. reduce the likelihood of child poisoning by accidental consumption of 
nicotine;  
Protection of human health or safety  
8. Relevant documents:   
The Delegate's interim decision to clarify that nicotine for all human use (other than in 
specified nicotine replacement therapies and in tobacco prepared and packed for smoking) 
is included in Schedule 4 of the Poisons Standard is available here: 
https://www.tga.gov.au/scheduling -decision -interim/notice -interim -decision -amend -
current -poisons -standard -relation -nicotine . 
More information is available here: https://www.tga.gov.au/nicotine -scheduling  
9. Proposed date of adoption:  The Delegate's interim decision was published on 23 
September 2020 with a final decisi on expected in December 2020.  
Proposed date of entry into force:  1 June 2021 ; The Delegate is likely to consider 
entry into force on either 1 April 2020 or 1 June 2020.  G/TBT/N/AUS/125  
 
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  10. Final date for comments:  60 days from notification; The Delegate is anticipated to 
make a decision by December.  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
All information is available here: https://www.tga.gov.au/nicotine -scheduling . 
https://www.tga.gov.au/nicotine -scheduling  
 