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About MDMA and psilocybine
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 products require 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.
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 unapproved therapeutic goods and all products.
