MDMA and psilocybine are unapproved medicines. This means they have not been evaluated by the TGA for quality, safety and efficacy and included in the Australian Register of Therapeutic Goods (ARTG).
The following checklists summarise the key obligations for psychiatrists applying to access MDMA and psilocybine as unapproved medicines.
Checklist for prescribing psychiatrists of MDMA and psilocybine
Become an Authorised Prescriber
To access products containing MDMA or psilocybine for psychedelic-assisted psychotherapy you must:
- Be registered as a specialist psychiatrist with the Medical Board of Australia.
- Develop a clinical treatment protocol aligned with published studies and the TGA checklist (including patient information and consent forms).
- Submit an application with the clinical treatment protocol (including patient information and consent forms) to a registered HREC and receive approval).
- Apply to the TGA to become an Authorised Prescriber for each product you want to access through the Special Access Scheme (SAS) and Authorised Prescriber (AP) Online System. You must register an account to do so. You will need to attach:
- The HREC approval letter
- Clinical treatment protocol, patient information and consent forms
- Other supporting documents (such as a curriculum vitae).
Become an Authorised Prescriber
If authorised, you can access:
- MDMA for post-traumatic stress disorder (PTSD)
- psilocybine for treatment-resistant depression (TRD)
Before you apply to prescribe an unapproved MDMA or psilocybine product, you should:
- consider approved products included in the ARTG for your patient's medical condition
- consider risks of treatment
- obtain informed consent
- adhere to relevant standards of good medical practice
- check state and territory requirements
- check the product is available and affordable for the patient.
Read more about the SAS and AP Online System.
Guidance documents
The following TGA guidance documents may be useful when applying to become an Authorised Prescriber.
Clinical resources
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) established a Psychedelic-Assisted Therapy Steering Group to assist psychiatrists with clinical guidance. This includes a clinical memorandum on the therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression.
RANZCP have also published a training framework for psychiatrists which sets out the minimum training expectations for psychiatrists who wish to become an Authorised Prescriber of MDMA and psilocybine.
State and territory requirements
For advice on the interpretation of the Poisons Standard or the legal requirements for the supply, prescribing and storage of MDMA and psilocybine-containing products prior to submission of an application under the Authorised Prescriber scheme, contact your state or territory.
See the list of contacts for state/territory medicines and poisons regulation units.
You may also need to apply for approval or permission from the relevant state or territory health department to prescribe scheduled medicines.
Obtaining MDMA and psilocybine containing products
As the Authorised Prescriber, it is your responsibility to source the product.
You will be able to either import MDMA or psilocybine directly or obtain them from an Australian manufacturer or an importer.
You may also engage another party (such as a pharmacist) to source the product on your behalf.
The importation of MDMA and psilocybine is prohibited unless the importer holds a licence and permit issued by the Office of Drug Control. Read about importing and regulation of MDMA and psilocybine.
Read more about how to supply, manufacture or import MDMA or psilocybine (sponsors and manufacturers).
Reporting requirements
As an Authorised Prescriber, you must report the number of patients you have treated with each unapproved product.
You must submit a report every 6 months for each AP authorisation you hold.
Read how about your reporting requirements when you prescribe unapproved products for multiple patients (Authorised Prescriber).
Follow the AP six‑monthly reporting user guide when completing and submitting AP reports.
To submit your Authorised Prescriber six monthly reports, go to the SAS and AP Online System.
Read more about the SAS and AP Online System.
Reporting side effects
You are responsible for reporting adverse events or defects from the use of unapproved therapeutic goods you’ve prescribed.
Read how to report a problem or side effect.
Advertising requirements
All advertising of therapeutic goods in Australia is subject to the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code.
Medicines containing substances included in Schedule 8 to the Poisons Standard, including those containing MDMA and psilocybine, are prohibited from being advertised to the public.
You must not promote, either expressly or by implication, the use or supply of MDMA or psilocybine in any content available to members of the public. This means that it is illegal for prescribers or healthcare facilities to indicate that they can prescribe and/or supply MDMA and/or psilocybine. Substantial penalties apply.
MDMA and psilocybine may be advertised exclusively to health professionals, including psychiatrists and pharmacists. The TGA has published guidance on exclusively advertising to health professionals.
Clinical trials
To see a list of clinical trials being undertaken in Australia, New Zealand and elsewhere use the Australian New Zealand Clinical Trial Registry (ANZCTR).
Note that some trials undertaken in Australia may be registered with registries other than the ANZCTR. You can search the International Clinical Trials Registry Platform (ICTRP).