G/TBT/N/AUS/127  
6 January 2021  
(21-0196) 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):  Medicines; 
PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  Proposed update 
to the sta ndard - Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 
2017 
6. Description of content:  The Therapeutic Goods Administration (TGA) is proposing to 
update the regulation of medicinal cannabis labelling and packaging. The proposal reform 
seeks to:  
• provide clarity to the stated content of active ingredients and establish new 
labelling requirements  
• introduce a requirement for child -resistant closures in the interest of public 
safety  
The update to the standard is not intended to impose significant regulatory burden or 
create barriers to supply cannabis goods in Australia.  
A public consultation on the draft changes to the standard is currently open and closed 
on 29th January 2021. The consultation documents are available via the link prov ided 
below.  
The TGA will review all the submissions received and will make changes to the draft 
standard and associated guidance in consideration of this feedback. It is planned that 
there will be a transition period to allow sufficient time for suppliers of medicinal cannabis 
products to comply with any updates to the standard.  G/TBT/N/AUS/127  
 
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  7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of the proposed reforms is to provide greater assurance for 
medical practitioner s and patients regarding the quality and safety of medicinal cannabis 
products that are imported and supplied in Australia. Key to this is the need for a 
consistent approach to how cannabis ingredients are named, accurately described and 
differentiated. Th is will improve consistency across medicine labels, reduce confusion and 
avoid dosing errors.; Consumer information, labelling; Protection of human health or 
safety; Quality requirements  
8. Relevant documents:   
The proposed standard and consultation documents are available here. The proposed 
standard will be updated  in consideration of the consultation feedback, before it is 
implemented.  
9. Proposed date of adoption:  30 April 2021 ; An updated version of the standard is likely 
to be implemented in Q2 2021 with a transition period.  
Proposed date of entry into force:  29 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:   
https://www.tga.gov.au/consultation/consultation -potential -reforms -medicinal -
cannabis -manufacturing -labellin g-and-packing -requirement