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While MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine are listed as Schedule 9 substances in the Poisons Standard, from 1 July 2023 these substances will also be listed under Schedule 8 of the Poisons Standard for use in the treatment of certain mental health conditions. This change will allow specifically authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybine for treatment-resistant depression from 1 July 2023.
The decision, to reschedule MDMA and psilocybine, acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses and comes following applications made to the Therapeutic Goods Administration (TGA) to reclassify the substances within the Poisons Standard, extensive public consultation and a report from an independent expert panel which evaluated the therapeutic value, benefits, and risks of both MDMA and psilocybine for the treatment of mental, behavioural or developmental disorders.
Within Australia the Office of Drug Control (ODC) regulates the import and export of psychotropic substances under the Convention on Psychotropic Substances of 1971. State and territory governments also regulate psychotropic substances, such as MDMA and psilocybine, under their poisons legislation.
The ODC also reports on quantities of MDMA and psilocybine manufactured, sold, used and stock levels, to meet Australia’s obligations under the international drug conventions.
Manufacture of MDMA and Psilocybine
Until recently MDMA and psilocybine were prohibited drugs, as classified in the Poisons Standard. With the upcoming change to the scheduling of MDMA and psilocybine there is increased interest in domestic manufacture.
However, the ODC does not have the power to grant permission to manufacture MDMA or psilocybine in Australia. Manufacture regulation may be the responsibility of states and territories, however in relation MDMA and psilocybine, states and territories may only have limited powers for specific circumstances (e.g. research). Domestic manufacturers of any therapeutic good, including ingredients used in therapeutic goods, may also be required to be licenced by the TGA.
The regulation of MDMA and psilocybine may change in the future so you should monitor for any updates on our website.
The ODC 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.
To learn more about the role of the ODC see About us | Office of Drug Control (ODC)
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 please see Clinical trials | Therapeutic Goods Administration (TGA)
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 regarding access to MDMA or psilocybine, please see Access to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic purposes – information for psychiatrist prescribers | Therapeutic Goods Administration (TGA)
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 following Special Access Scheme/AP import application: https://www.odc.gov.au/about-us/licences-and-permits/apply-permit-import-special-access-scheme-sas-only
Authorised Prescribers must first obtain approval from the TGA, and then provide a copy of the approval letter that was issued to them when submitting their import application.
Pharmacists
Depending on state and territory requirements, pharmacies may be able to import MDMA or psilocybine on behalf of Authorised Prescribers by completing the following Special Access Scheme/AP import application: https://www.odc.gov.au/about-us/licences-and-permits/apply-permit-import-special-access-scheme-sas-only
Pharmacists must provide the reference number issued by the TGA to the Authorised Prescriber when submitting the import application.
Wholesalers
Depending on state and territory requirements, wholesalers may be able to import MDMA or psilocybin on behalf of Authorised Prescribers through a licence and permit application.
Licence application
Permit application
Import licence applications must be accompanied by the requisite Schedule 8 approval from the state/territory Health Department in your jurisdiction.
Wholesalers must provide the reference number issued by the TGA to the Authorised Prescriber when submitting the import application.
Clinical Trials involving MDMA and psilocybine require a separate import licence and permit.
Licence application
Permit application
Import licence applications must be accompanied by the requisite Schedule 8 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, the ODC is 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.
Please contact the ODC for instructions on reporting obligations at ncs@health.gov.au
Other Information
For further information please see the following links:
General information regarding the down-scheduling of MDMA and psilocybine
Independent expert panel
Independent Expert Panel on MDMA and psilocybin | Therapeutic Goods Administration (TGA)
Notice of Final Decision - June 2022
Further information regarding the Poisons Standard
The Poisons Standard (the SUSMP) | Therapeutic Goods Administration (TGA)
MDMA and Psilocybine questions and answers