To access products containing MDMA or psilocybine, 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 access.
You must prescribe the products in accordance with the relevant legislative requirements in your state or territory.
If authorised, you can access:
- MDMA for post-traumatic stress disorder (PTSD)
- psilocybine 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
Before you apply to prescribe an unapproved MDMA or psilocybine product, you should:
- consider approved products 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.
To become an Authorised Prescriber of products containing MDMA or psilocybine, you will need human research ethics committee (HREC) approval.
The approval process from the HREC consists of a submission and approval of an appropriate clinical protocol for the delivery of psychedelic-assisted psychotherapy.
When you apply to the TGA, use the standard pathway. You can't use the established history of use pathway for MDMA or psilocybine. You will need to provide both your HREC approval and clinical protocol as part of your application.
To become an Authorised Prescriber you must use the Special Access Scheme (SAS) and Authorised Prescriber (AP) Online System. You must register an account to do so.
Guidance documents
You can access resources including a checklist with key obligations for psychiatrists applying to prescribe and access MDMA and psilocybine.
Clinical resources
The Royal Australian and New Zealand College of Psychiatrists (RANZCP) has established a Psychedelic-Assisted Therapy Steering Group to assist psychiatrists with clinical guidance. This includes a detailed clinical memorandum on the therapeutic use of MDMA for PTSD and psilocybin for treatment resistant depression.
Read the RANZCP information about psychedelics.
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 psilocybin-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 certain scheduled medicines.
Obtaining MDMA and psilocybin containing products
As the Authorised Prescriber, it is your responsibility to source the product.
You will be able to either import MDMA or psilocybin 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 psilocybin 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 psilocybin.
Read more about how to supply, manufacture or import MDMA or psilocybin (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 report this every 6 months you are authorised to prescribe.
Read how about your reporting requirements when you prescribe unapproved products for multiple patients (Authorised Prescriber).
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 must report any suspected adverse events or defects within 15 days of learning of them.
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 psilocybin, are prohibited from being advertised to the public.
You must not promote, either expressly or by implication, the use or supply of MDMA or psilocybin 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 psilocybin. Substantial penalties apply.
MDMA and psilocybin 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).