  
  
G/TBT/N/AUS/136  
22 December 2021  
(21-9574) 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:  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):  Medicinal 
cannabis products (being therapeutic goods that contain, or are manufactured from, any 
part of the cannabis plant) and any ingre dients used in the manufacture of those products 
(including, but not limited to, the cannabis plant). For the purposes of this notification, 
'cannabis plant' means any plant, or part of a plant, of the genus Cannabis, including, but 
not limited to, the flo wers, fruiting tops, seeds, stems and leaves of the plant.; 
PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and language(s) of the notified document:  Reforms to 
medicinal cannabis manufacturing, labelling and packaging requirements.  
6. Descript ion of content:  The Therapeutic Goods Administration (TGA) is seeking 
comment on a package of reforms in relation to the manufacturing, labelling and 
packaging requirements for Medicinal Cannabis Products made available in Australia or 
supplied to Australi ans. 
Background  
In recent years, Australian Governments at Commonwealth, State and Territory levels 
have implemented legislative and policy changes to allow the cultivation, manufacture 
and supply of medicinal cannabis for patients in Australia.  
The TGA administers Australia's national system of controls for the quality, safety, efficacy 
and timely availability of therapeutic goods in Australia. Typically, therapeutic goods must 
be included in the Australian Register of Therapeutic Goods (ARTG). If they a re not 
included in the ARTG, these goods can only be lawfully supplied in, imported into, or 
exported from Australia if they are subject to an exemption, approval or authority. 
Therapeutic goods not on the ARTG are referred to as 'unapproved products'. Cur rently, 
most medicinal cannabis products are unapproved products.  
Unapproved medicinal cannabis products can be accessed via the Authorised Prescriber 
Scheme (AP), Special Access Scheme (SAS) or clinical trials.  G/TBT/N/AUS/136  
 
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  The TGA requires certain standards for medic inal cannabis products accessed in Australia, 
as set out principally in TGO 93. At present, Australian manufacturers must comply with 
Good Manufacturing Practice (GMP) standards, whereas a similar requirement does not 
apply to product imported into Austral ia. 
Reform proposal  
There has been a significant increase in the supply and use of medicinal cannabis products 
in Australia. In light of this, the TGA recently undertook a review of the regulation of 
medicinal cannabis products manufacturing, labelling and  packaging, which included a 
public consultation held between December 2020 and January 2021. The TGA has 
subsequently developed a package of reforms, described below.  
TGO 93 and the Regulations are proposed to be amended to require the following:  
• Imported  medicinal cannabis products will be required to be manufactured on 
sites with acceptable GMP standards. Sponsors (the companies importing the 
goods) must maintain evidence to show compliance for each batch of medicinal 
cannabis products. The TGA will prov ide sponsors with clear guidance on the 
GMP practices and evidence required, which will be in accordance with existing 
recognised global standards and/or accreditation. This measure provides greater 
certainty on the quality and safety of products available  to Australian patients. 
It extends broadly the same standards to offshore manufacturers currently 
required of Australian manufacturers.  For the avoidance of doubt, the TGA will 
not be requiring sponsors of offshore manufacturers to comply with a unique 
Australian manufacturing standard. Sponsors will be able to rely on a 
manufacturer's adherence to an internationally accepted GMP standard (of a 
type acceptable to the TGA) that may be specific to that manufacturer's 
country.  
• Extemporaneous compounding by me dical practitioners and pharmacists will 
require approval from the TGA under the Special Access Scheme (SAS). 
Medicinal cannabis manufactured outside of Australia can still be used in 
extemporaneous compounding.  
• TGO 93 will be amended to include requiremen ts for (a) a child resistant closure 
on high risk goods, which is normal practice for medicines that present a 
poisoning risk (b) labelling that better identifies the active ingredients and (c) 
clarity on microbiological testing requirements. Clear guidanc e on the 
requirements – and a reasonable transition period – will be provided.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the package of reforms are to:  
• Provide assistance to patients and medicinal practitioners to identify equivalent 
products within the large range of products available. This will be achieved by 
requiring more information on product label s. 
• Provide greater certainty to Australian patients and medical practitioners around 
quality and safety by ensuring that both Australian and international medicinal 
cannabis manufacturers are subject to similar manufacturing standards.  
• Provide clarity for sponsors and manufacturers operating in multiple jurisdictions 
as to the minimum safety and quality requirements in Australia.  
• Improve regulatory oversight of extemporaneous compounding of medicinal 
cannabis products by medicinal practitioners and pharmaci sts. 
Consumer information, labelling; Protection of human health or safety; Quality 
requirements  
8. Relevant documents:   
Proposed reforms which will be implemented through updates to:  
(a) the existing Standard for Medicinal Cannabis Therapeutic Goods (Standard for 
Medicinal Cannabis) (TGO93) Order 2017;  G/TBT/N/AUS/136  
 
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  (b) the Therapeutic Goods Regulations 1989; and  
(c) the Narcotic Drugs Regulations 2016.  
(together, the Regulations)  
The proposal for comment is the suite of reforms, in principle. The updated TGO and 
Regulations are currently being drafted and are intended to reflect the reform proposal 
described in this notification.  
An initial consultation was held between December 2020 and January 2021. The 
consultation paper and a sub sequent statement are online at 
http://www.tga.gov.au/consultation/consultation -potential -reforms -medicinal -cannabis -
manufacturing -labelling -and-packing -requirement  
9. Proposed date of adoption:  The proposed amendments to TGO 93 and to the 
Regulations are proposed to be finalised and published in March 2022.  
The TGA intends to provide a reasonable transition period.  
Proposed date of entry into force:  This period will be determined in consultation with 
industry and is likely be up to 12 months.  
10. Final date for comments:  20 February 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
 