From 1 July 2023, certain psychiatrists can prescribe medicines containing MDMA or psilocybin for specific patients under strict regulatory controls.
The Office of Drug Control (ODC) regulates the import, export and manufacture of these substances, while the Therapeutic Goods Administration (TGA) regulates their therapeutic use.
This page explains the regulatory framework for MDMA and psilocybin and provides links to further guidance.
Key information
- MDMA and psilocybin remain controlled substances.
- Their use is limited to specific therapeutic purposes under Australian regulatory controls.
- Only authorised prescribers may prescribe these substances for eligible patients.
- ODC licences and permits are still required for import, export and manufacture activities.
Manufacture of MDMA and Psilocybine
With the change to the scheduling of MDMA and psilocybine there is increased interest in domestic manufacture.
It should be noted however that the scheduling change applies to final preparations, so the raw material or active pharmaceutical ingredient (API) remains classified as Schedule 9 (Prohibited Drugs) in the Poisons Standard. Subject to each state and territory, the controls over manufacture and supply of these drugs (not in the final preparation form) may vary between jurisdictions and could be prohibited in some cases.
Under Commonwealth law, we do not have the power to grant permission to manufacture (synthesise) MDMA, cultivate psilocybine-containing mushrooms, or manufacture (synthesise) psilocybine in Australia.
Regulation of manufacture may be the responsibility of states and territories, however since most of the manufacturing and supply chain is classified as schedule 9 (Prohibited Drugs) the jurisdiction may only have limited powers in specific circumstances (e.g. research).
The TGA does have powers to licence the manufacture of MDMA and psilocybine as therapeutic goods under a GMP (Good Manufacturing Practice) Licence.
We will endeavour to assist in responding to enquiries on manufacture; however you should check with your state or territory Health Department for advice on whether they have the legal powers to grant permission to manufacture in your jurisdiction.
The regulation of MDMA and psilocybine may change in the future so you should monitor for any updates on our website.
To learn more about our role see our About us page.
Access to MDMA or Psilocybine
How to obtain MDMA or psilocybine for use in a clinical trial or for prescription by an Authorised Prescriber
MDMA and psilocybine may be used in Australia for research and restricted medical purposes. Therapeutic goods supplied in clinical trials conducted in Australia are regulated by the TGA. Clinical trials are also subject to various regulatory controls including the Good Clinical Practice (GCP) Inspection Program to ensure the safety of participants. For more information regarding what is needed to undergo a clinical trial see the Clinical trials page on the TGA website.
All psychiatrists who wish to prescribe MDMA for the treatment of post-traumatic stress disorder or psilocybine for treatment-resistant depression must be approved under the Authorised Prescriber (AP) Scheme by the TGA following the approval of a human research ethics committee. This allows for the prescription of these psychotropic substances under strict controls that ensure the safety of patients whilst allowing those in need to have access to essential medications.
For more information, see the Access to MDMA and psilocybin for therapeutic purposes page on the TGA website.
Importation
The importation of MDMA and psilocybine is prohibited unless the importer holds a licence and permit issued by the ODC. A permit to import is required for each specific consignment of goods entering Australia and cannot be used for multiple shipments.
Authorised Prescribers can apply to import MDMA and psilocybine directly, by completing the Special Access Scheme/AP import application available on our website.
We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.
Pharmacists
Depending on state and territory requirements, pharmacies may be able to import MDMA or psilocybine on behalf of Authorised Prescribers by completing the Special Access Scheme/AP import application available on our website.
Pharmacists must provide details of the AP who will be prescribing the imported goods. We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.
Wholesalers
Depending on state and territory requirements, wholesalers may be able to import MDMA or psilocybine on behalf of AP’s through a licence and permit application.
Wholesalers must provide details of the AP who will be prescribing the imported goods and confirm where the drugs will be held until dispensed. Wholesalers of MDMA and psilocybine in these circumstances can only supply the drugs in relation to the AP’s provided in their applications.
We will verify with the TGA that the AP is approved to prescribe the drugs to be imported.
Licence application
Apply for a licence to import narcotic and psychotropic drugs and precursor substances
Permit application
Apply for a permit to import narcotic and psychotropic substances to Australia
Import licence applications must be accompanied by the requisite Schedule 8 and Schedule 9 (if applicable) approval from the state/territory Health Department in the relevant jurisdiction.
Clinical Trials involving MDMA and psilocybine require a separate import licence and permit.
Licence application
Apply for a licence to import narcotic and psychotropic drugs and precursor substances
Permit application
Apply for a permit to import narcotic and psychotropic substances to Australia
Import licence applications must be accompanied by the requisite Schedule 8 and and Schedule 9 (if applicable) approval from the state/territory Health Department in your jurisdiction.
Reporting
The ODC, on behalf of Australia, is responsible for ensuring Australia meets all international reporting obligations under the three international drug conventions: the Single Convention on Narcotic Drugs of 1961; the Convention on Psychotropic Substances of 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988.
As part of this, we are required to provide information to the International Narcotics Control Board (INCB) regarding the manufacture, cultivation, and production of internationally controlled substances, including MDMA and psilocybine.
Contact us at ncs@health.gov.au for guidance on reporting obligations.
Other information
For further information see the following links:
Change to classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists
Independent Expert Panel on MDMA and psilocybin
Notice of final decision to amend (or not amend) the current Poisons Standard
The Poisons Standard (the SUSMP)
Re-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answers