Authorised psychiatrists can prescribe products containing 3,4‑methylenedioxy‑methamphetamine (MDMA) or psilocybin for specific mental health conditions from 1 July 2023.
MDMA may be used for the treatment of post-traumatic stress disorder.
Psilocybin may be used for treatment-resistant depression.
Prescribe MDMA or psilocybin
To prescribe products containing MDMA or psilocybin, you must be a registered psychiatrist. You must have completed a Fellowship with the Royal Australian and New Zealand College of Psychiatrists (RANZCP).
You must also be an Authorised Prescriber for each product you want to prescribe.
If authorised, you can prescribe:
- MDMA for post-traumatic stress disorder (PTSD)
- psilocybin for treatment-resistant depression (TRD)
Before you apply to become an Authorised Prescriber, consider the treatment options included in the Australian Register of Therapeutic Goods.
Become an Authorised Prescriber
To become an Authorised Prescriber of products containing MDMA or psilocybin, you will need human research ethics committee (HREC) approval.
When you apply, use the standard pathway. You can't use the established history of use pathway for MDMA or psilocybin.
Read how to become an Authorised Prescriber.
- GuidanceAccess to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic purposes – information for psychiatrist prescribersThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybin from 1 July 2023.
- GuidanceAuthorised Prescriber SchemeGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors
- GuidanceAuthorised Prescriber Scheme online system guidanceThe Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications
Frequently asked questions (FAQ)
- PageRe-scheduling of psilocybin and MDMA in the Poisons Standard: questions and answersQuestions and answers about the changes in the scheduling of psilocybin and MDMA in the Poisons Standard
- PresentationsWebinar presentation: Change to classification of MDMA and psilocybin to enable prescribing by authorised psychiatristsThis webinar will address the recent announcement by the TGA that medicines containing psilocybin and MDMA will be conditionally classified as Schedule 8 (controlled drug) in the Poisons Standard.
- Media releasesChange to classification of psilocybin and MDMA to enable prescribing by authorised psychiatristsFrom 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.
- Scheduling decisions (final)Notice of final decision to amend (or not amend) the current Poisons Standard - June 2022 ACMS #38 - Psilocybine and MDMAPublic notice of final decisions to amend (or not amend) the Poisons Standard - ACMS, June 2022