If you're planning to supply MDMA or psilocybine for therapeutic use in Australia, this is your starting point.
Before you can supply MDMA or psilocybine, you must understand your responsibilities under an access pathway.
Being well prepared helps ensure lawful supply and avoids regulatory delays,
Start by reviewing your responsibilities and understanding the access pathways.
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.
General information
Learn about how products are regulated.
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PageFind out how we regulate clinical trials in Australia and ensure compliance with Good Clinical Practice.
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PageClinical resources and guidance on accessing MDMA and psilocybine under the Authorised Prescriber scheme.
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PageInformation for Australian sponsors on manufacturing, supplying and importing MDMA and psilocybine.
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GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
Ingredients and scheduling
Get information about ingredient approvals and scheduling requirements.
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PageSummary of a report to the Therapeutic Goods Administration.
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PageQuestions and answers about the changes in the scheduling of psilocybin and MDMA in the Poisons Standard
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PageLinks to and information on scheduling and the Poisons Standard including public notices, state and territory information, the scheduling advisory committees and proposed committee meeting dates and decision timeframes.
Legislation, Acts and Orders
Review the laws and legal orders that regulate therapeutic goods.
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PageFind information about legislation, acts and regulations, legislative instruments and other legislative information.
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LegislationThe TGO 112 Order 2024 sets forth the quality standards for MDMA (3,4-methylenedioxymethamphetamine) products, which must comply with specific requirements to ensure safety and efficacy.
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LegislationThe Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 establishes new quality standards for psilocybine products in Australia.
Standards and requirements
Understand product obligations for safety, quality and efficacy.
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GuidanceGuidance on how to comply with the quality standards for MDMA (TGO 112) and psilocybine (TGO 113).