Although the scheduling of MDMA and psilocybine in the Poisons Standard has changed, except for prescription for Authorised Prescribers, these substances remain as Schedule 9 (prohibited drugs).
The import, manufacture, possession and supply of these goods are prohibited under the Commonwealth Criminal Code, unless authorised under a law of the Commonwealth or a State or Territory.
This means that, in relation to goods containing MDMA or psilocybine, additional authorisation by law is required before engaging in any of these activities. Some of these activities are authorised under Commonwealth laws in certain circumstances (e.g. manufacturing on a site covered by a GMP licence from the TGA). In other cases, unless the activity is authorised under the relevant state or territory law, it will be unlawful.
In addition to compliance with Commonwealth laws, those involved in manufacture, possession and supply of goods containing MDMA and psilocybine must also comply with state and territory legislation that applies to these goods.
Role of the sponsor
A sponsor is a person or company who does one or more of the following:
- exports therapeutic goods from Australia
- imports therapeutic goods into Australia
- manufactures therapeutic goods for supply in Australia or elsewhere
- arranges for another party to import, export or manufacture therapeutic goods.
The person or company in Australia who provides a MDMA or psilocybine product to the Authorised Prescriber (in this case, the psychiatrist) is generally considered the 'sponsor' of that product.
In cases where the MDMA or psilocybine product is sourced from overseas by the Authorised Prescriber, the Authorised Prescriber may also be the sponsor of the medicine.
For more information read about the role of the sponsor.
Importing MDMA and psilocybine products
Goods containing MDMA or psilocybine may be imported directly by an Authorised Prescriber, or by another person (such as a pharmacist), only if:
- the possession and supply of the goods by the importer is authorised under a law of the relevant state or territory; and
- the Office of Drug Control issues a licence and permit to import- external site under the Customs (Prohibited Imports) Regulations 1956 to the importer in relation to the goods.
The Office of Drug Control will not issue a permit unless evidence is provided demonstrating that the possession and supply is authorised under a law of the relevant state or territory authority. Evidence must also be provided that the goods are:
- for supply under a clinical trial that is authorised or exempt under the Therapeutic Goods Act 1989; or
- for supply under an Authorised Prescriber authority that is in force at the time of the importation; or
- approved for a scientific purpose and exempt under the Therapeutic Goods Act 1989.
Authorisation to supply the goods under a law of the relevant state or territory is also necessary to ensure that offences under the Commonwealth Criminal Code relating to the supply of controlled drugs do not apply. A licence and permit to import under the Customs (Prohibited Imports) Regulations 1956 does not displace offences under the Commonwealth Criminal Code relating to the supply of controlled drugs.
Goods containing MDMA or psilocybine can only be supplied by an importer to:
- a sponsor of a clinical trial that is authorised or exempt under the Therapeutic Goods Act 1989; or
- an Authorised Prescriber who holds an authority to supply those substances, that is in force at the time of supply; or
- a person that has an arrangement with an Authorised Prescriber to supply the goods to the Authorised Prescriber for the purpose of subsequent supply by the Authorised Prescriber to a patient (this could include a pharmacist).
Read more about importing therapeutic goods.
Manufacturing MDMA and psilocybine as therapeutic goods
Manufacture of MDMA and psilocybine as an active pharmaceutical ingredient (API) or finished product for human therapeutic use requires a Good Manufacturing Practice (GMP) licence from the TGA. A GMP licensed manufacturer must also ensure that the manufacture of goods containing MDMA and psilocybine (as Schedule 8 or Schedule 9 substances) is permitted by the law of the state or territory.
The TGA GMP licence held by an existing manufacturer, who applies to manufacture MDMA or psilocybine, will be conditioned to require reporting on the quantity of goods held and supplied. This reporting is necessary under Australia’s international obligations.
Any site applying for a new TGA GMP licence will require specific authorisations under that licence to manufacture MDMA or psilocybine medicines and similarly have conditions to report on the quantity of goods held and supplied.
A manufacturer of goods containing MDMA or psilocybine must also ensure that an exemption, approval, or authority under the Therapeutic Goods Act 1989 applies to the goods. As the only exemptions and authorities that are currently applicable to MDMA and psilocybine relate to clinical trials and Authorised Prescribers, the goods may only be manufactured for and supplied to:
- a sponsor of a clinical trial that is authorised or exempt under the Therapeutic Goods Act 1989; or
- an Authorised Prescriber who holds an authority to supply the goods that is in force at the time the goods are supplied by the manufacturer; or
- a person that has an arrangement with the Authorised Prescriber to supply the goods to the Authorised Prescriber for the purpose of subsequent supply by the Authorised Prescriber to a patient. This could include supply to a pharmacist or compounding pharmacy that has an arrangement to supply the goods to an Authorised Prescriber.
Manufacturers of MDMA or psilocybine medicines must also ensure they are authorised to supply the goods under a law of the relevant state or territory. This is necessary to ensure that offences under the Commonwealth Criminal Code relating to the supply of controlled drugs do not apply. A GMP licence under the Therapeutic Goods Act 1989 does not displace offences under the Commonwealth Criminal Code relating to the supply of controlled drugs.
Note: For psilocybine obtained from Psilocybe cubensis, manufacturing commences after the cultivation and drying of the mushroom. The cultivation of mushrooms containing psilocybine is not regarded as part of manufacture under the Therapeutic Goods Act 1989 and is not regulated by the TGA or the ODC. A cultivation licence must be issued by the relevant state or territory authority before cultivation occur.
Information for intermediate suppliers
The wholesaling of finished goods containing MDMA or psilocybine is not permitted under the Therapeutic Goods Act 1989 unless the goods are entered on the Australian Register of Therapeutic Goods (ARTG) or supplied under an exemption, approval or authority. As the only exemptions and authorities that are currently applicable to MDMA and psilocybine relate to clinical trials and Authorised Prescribers, the goods may only be supplied to:
- a sponsor of a clinical trial that is authorised or exempt under the Therapeutic Goods Act 1989; or
- an Authorised Prescriber that holds an authority in relation to the goods that is in force at the time of supply; or
- a third party (including a pharmacist) that has an arrangement/s with an Authorised Prescriber, or a sponsor of a clinical trial that is covered by a clinical trial authorisation or exemption, to hold the goods on behalf of or supply the goods to the Authorised Prescriber or clinical trial sponsor.
A third party that possesses or supplies MDMA or psilocybine medicines must also ensure they are authorised to do so under a law of the relevant state or territory. This is necessary to ensure that offences under the Commonwealth Criminal Code do not apply. The exemptions under the Therapeutic Goods Act 1989 that displace offences under that Act, relating to the supply of unapproved goods in this context, do not displace offences under the Commonwealth Criminal Code relating to possession and supply of controlled drugs.
Quality standards for MDMA and psilocybine products
Sponsors of MDMA and psilocybine products are legally responsible for ensuring their products comply with therapeutic goods orders (TGOs) and all other relevant standards.
Therapeutic Goods (Standard for MDMA) (TGO 112) Order 2024 is the standard that specifies the minimum quality requirements for MDMA active pharmaceutical ingredient (API) and finished product.
Therapeutic Goods (Standard for psilocybine) (TGO 113) Order 2024 is the standard that specifies the minimum quality requirements for psilocybine API and finished product.
From 6 January 2025 all MDMA and psilocybine API and finished product supplied in Australia must comply with TGO 112 and TGO 113 respectively. Sponsors and manufacturers are reminded there may be other relevant standards their products must comply with prior to 6 January 2025. There are civil and criminal penalties under sections 14 and 14A of the Therapeutic Goods Act 1989 for the import, export and supply of medicines that do not comply with a standard.
Other regulatory obligations
Read about your regulatory obligations if you supply an unapproved therapeutic good (sponsors).
Further help
- You should seek the services of a regulatory affairs consultant for specific advice and assistance in relation to product development and regulatory requirements.
- Enquiries related to the import of MDMA and psilocybine products, should be directed to the Office of Drug Control.
- For questions relating to manufacturing and quality of MDMA and psilocybine please contact gmp@health.gov.au
- SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), start-ups and researchers who are developing new medicines and medical devices understand their regulatory and legislative obligations.