If you are manufacturing, importing or supplying MDMA and psilocybine products for therapeutic use in Australia, there are rules you must follow.
As MDMA and psilocybine are unapproved therapeutic goods, they can be legally supplied through clinical trials or by an authorised psychiatrist under the Authorised Prescriber Scheme.
You are responsible for ensuring that an exemption or authorisation is in place before supplying these products.
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.
Supply
Understand your obligations to manage the ongoing supply of products.
-
GuidanceThis guidance is to assist sponsors understand their requirements when supplying ‘unapproved’ therapeutic goods under the Special Access Scheme and Authorised Prescriber Pathway.
-
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.
-
LegislationThe Therapeutic Goods (Standard for Psilocybine) (TGO 113) Order 2024 establishes new quality standards for psilocybine products in Australia.
Import and export
Access requirements for import and export of therapeutic goods.
-
FormsImport/export of unapproved therapeutic goods for experimental purposes
-
PageInformation for Australian sponsors on manufacturing, supplying and importing MDMA and psilocybine.