MDMA and psilocybine are controlled substances regulated as therapeutic goods in Australia. These are unapproved therapeutic goods, meaning they are not included in the Australian Register of Therapeutic Goods (ARTG) and have not been assessed by us for safety, quality or effectiveness.
Access to MDMA and psilocybine requires authorisation via the Authorised Prescriber Scheme.
Access is restricted to psychiatrists who have been authorised under this pathway. Sponsors must ensure all supply complies with relevant legislative requirements.
MDMA and psilocybine can also be accessed through clinical trials. For further information on how to access MDMA and psilocybine through clinical trials, please refer to Clinical trials.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to unapproved therapeutic goods. You may also have to meet obligations that apply to all products.
Authorised Prescriber Scheme
Learn how prescribers can apply to the Authorised Prescriber Scheme.
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ServiceAs a medical practitioner, you can apply to access an unapproved therapeutic good for a class of patients with the same condition.
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GuidanceThis guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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PageInformation for pharmacists on dispensing, supplying and compounding MDMA and psilocybine.
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PageAuthorised psychiatrists can prescribe MDMA and psilocybine for specific mental health conditions from 1 July 2023.
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User guideA step-by-step guide to completing the form
Clinical trial schemes
Find how to access unapproved goods through clinical trials.
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PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.