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An overview of MDMA and psilocybine

Information about MDMA and psilocybine and your obligations under the supply pathways.  

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.

Ingredients and scheduling

Get information about ingredient approvals and scheduling requirements.

Legislation, Acts and Orders

Review the laws and legal orders that regulate therapeutic goods.

Standards and requirements

Understand product obligations for safety, quality and efficacy.

Product types