G/TBT/N/AUS/165  
18 December 2023  
(23-8664) 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 and Aged Care  
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:   
Australian WTO TBT Enquiry Point  
Office of Global Trade Negotiations  
Department of Foreign Affairs and Trade  
Canberra ACT 0221 tbt.enquiry@dfat.gov.au  
+61 2 6261 1111  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN  where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medicines  
5. Title, number of pages and language(s) of the notified document:  Consultation 
paper – Proposed quality standards for MDMA and ps ilocybin; (36 page(s), in English)  
6. Description of content:  The Therapeutic Goods Administration (TGA) administers 
Australia's national system of controls for the quality, safety, efficacy and timely 
availability of therapeutic goods in Australia.  
There are provisions under the Therapeutic Goods Act 1989  to establish quality standards 
for therapeutic goods. These standards, known as TGOs, can specify things such as 
procedures to be carried out in the manufacture of the goods, labelling, or other 
requirements. Once approved, TGOs are registered as legislative instruments on the 
Federal Register of Legislation in Australia.  
The TGA has developed two new quality standards that will be registered as legislative 
instruments on the Federal Register of Legi slation in Australia as Therapeutic Goods 
Orders (TGOs):  
• Standard for MDMA hydrochloride, and  
• Standard for Psilocybin  
The TGA is undertaking a public consultation between Friday 8 December 2023 to 
Wednesday 31 January 2024 to seek feedback on the appropria teness of the requirements 
in the TGOs.  G/TBT/N/AUS/165  
 
- 2 - 
 
  Until 1 July 2023 Australian patients only had access to therapy with 
,4-methylenedioxy -N-methylamphetamine hydrochloride (MDMA) and psilocybin as part 
of clinical trials.  
Effective from 1 July 2023, the TGA amended the Poisons Standard to add MDMA and 
psilocybin to Schedule 8 (S8), permitting their use as Controlled Drugs only for the 
treatment of post -traumatic stress disorder (PTSD) and treatment resistant depression 
(TRD), respectively. Only authorised med ical practitioners are permitted to prescribe S8 
MDMA and psilocybin.  
There are no quality standards such as pharmacopoeial monographs or TGOs for MDMA 
or psilocybin. The TGA has developed manufacturing and testing requirements that will 
form the basis of proposed new TGOs for each of these medicines.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The proposed TGOs have been developed in consultation with manufacturers 
making MDMA and psilocybin for clinical trials an d are based on the current methodologies 
and testing limits used by these manufacturers, for both the active pharmaceutical 
ingredient (API) and finished product.  
The TGOs will provide medical practitioners and the Australian public confidence that 
these g oods meet quality expectations for safety and efficacy.  
The public consultation on the draft TGOs  allows manufacturers, medical practitioners, 
patients and other interested stakeholders the opportunity to comment on the proposed 
quality requirements.  
The TGA expect to finalise the TGOs in February 2024 and register them on the Federal 
Register of Legi slation in March 2024. The TGA propose to implement the requirements 
from the date of commencement of the TGOs.; Protection of human health or safety  
8. Relevant documents:   
The consultation paper is available at https://consultations.tga.gov.au/tga/proposed -
quality -standards -for-mdma -and-psilocybin  
9. Proposed date of adoption:  Aiming for February 2024, with consideration to be made 
based on the number of comments and submissions received.  
Proposed date of entry into force:  March 2024  
10. Final date for comments:  31 January 2024  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
TGA website: https://ww w.tga.gov.au/resources/consultation/consultation -proposed -
quality -standards -mdma -and-psilocybin  
Consultation hub: https://consultations.tga.gov.au/tga/proposed -quality -standards -for-
mdma -and-psilocybin  
https://co nsultations.tga.gov.au/tga/proposed -quality -standards -for-mdma -and-
psilocybin