Accessing MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine as a psychiatrist

Generally, medicines used in Australia must be included in the Australian Register of Therapeutic Goods (ARTG). Products containing MDMA or psilocybine are not included in the ARTG. They are referred to as ‘unapproved’ therapeutic goods. 

The TGA provides pathways that allow access to unapproved psychedelics, through the Authorised Prescriber (AP) scheme and clinical trials. 

Scheduling

MDMA for the treatment of post-traumatic stress disorder and psilocybine for treatment-resistant depression are classified under Schedule 8 in the Poisons Standard (the SUSMP). 

This means they can be accessed outside clinical trials, but only under strict conditions.

Appendix D of the Poisons Standard restricts access to the substances under Schedule 8 under the following conditions:

• MDMA or psilocybine must be prescribed by specialist psychiatrists registered with the Medical Board of Australia; and
• the psychiatrist must have approval from a Human Research Ethics Committee (HREC), and be specifically authorised by the TGA under the Authorised Prescriber (AP) scheme; and

• possession of these substances without appropriate regulatory authority or a valid prescription is illegal 

Protocols that allow patients to take these medicines home are not accepted under the AP scheme.

For all other indications MDMA and psilocybine are still prohibited substances in Schedule 9 of the Poisons Standard, limiting their use to medical and scientific research, such as clinical trials.

For further information visit Re-scheduling of psilocybine and MDMA in the Poisons Standard: questions and answers.

The AP scheme allows the TGA to grant a medical practitioner authority to prescribe a specified unapproved therapeutic product for particular indications to a class of patients in their immediate care.

The steps and checklist below outline the requirements for psychiatrists seeking access to prescribe MDMA or psilocybine, as unapproved medicines for psychedelic-assisted psychotherapy: 

1. Hold specialist registration as a psychiatrist with the Medical Board of Australia.
2. Develop a clinical treatment protocol aligned with published studies and the TGA’s Checklists for prescribing psychiatrists of MDMA or psilocybine (including patient information and consent forms).
3. Apply to a registered HREC with the clinical treatment protocol and receive approval.
4. Apply to the TGA to become an Authorised Prescriber for each product you want to access using the Special Access Scheme and Authorised Prescriber Online System. You must register an account to do so. You will need to attach:
5. The HREC approval letter
6. Clinical treatment protocol, patient information and consent forms
7. Other supporting documents (such as a curriculum vitae)

Once you hold an AP authority, you do not need to notify the TGA each time you prescribe the unapproved product. 

As an AP you must report the number of patients you have treated with each unapproved product. You must submit a report every 6 months for each AP authorisation you hold. 

Read how about your reporting requirements when you prescribe unapproved products for multiple patients (Authorised Prescriber).

Follow the AP six‑monthly reporting user guide when completing and submitting AP reports.

To submit your Authorised Prescriber six monthly reports, go to the SAS and AP Online System.

Read more about the SAS and AP Online System.  

For further information visit the Authorised Prescriber Scheme guidance document.

There is no application fee.

The scheduling of MDMA and psilocybine restricts the prescribing of these medicines to psychiatrists registered with the Medical Board of Australia as a specialist psychiatrist. 

You will need to provide your Australian Health Practitioner Regulation Agency (Ahpra) registration number to the TGA as part of your application.

Part 2: Develop a clinical treatment protocol

You are required to provide a clinical treatment protocol as part of your HREC application and your AP application to the TGA. The requirements for this clinical treatment protocol must include, but are not limited to the information found in the TGA’s Checklists for prescribing psychiatrists of MDMA or psilocybine.

The TGA administers access to MDMA and psilocybine containing products through the AP scheme however does not provide clinical practice guidance. 

The Royal Australian and New Zealand College of Psychiatrists (RANZCP) established a RANZCP Psychedelic-Assisted Therapy Steering Group to assist psychiatrists with clinical guidance including a Clinical Memorandum. It is recommended that advice by the RANZCP is followed when developing a clinical treatment protocol. Information is available on the RANZCP Psychedelics hub.

Your clinical treatment protocol should be consistent with approaches used in recent Australian and international clinical trials of MDMA (for PTSD) and psilocybine (for TRD) for use in psychedelic-assisted psychotherapy. 

Specific criteria for MDMA and psilocybine applications are outlined below.

A: Medical practitioner training and experience

The psychiatrist must provide evidence of experience in psychedelic-assisted psychotherapy through involvement in clinical trials.

OR

The psychiatrist must provide evidence that they have received or are currently receiving supervision in psychedelic-assisted psychotherapy from an experienced Authorised Prescriber.

Psychiatrists should refer to appropriate guidance from RANZCP regarding specific supervision and supervisor experience criteria.

B: Treatment site

The TGA expects that the minimum requirements for a treatment site are a medically supervised facility with robust emergency management protocols and compliant Schedule 8 medicine handling procedures that adhere to all state and territory requirements.

You must provide details of the treatment site to demonstrate it is a suitable medically supervised environment. The AP is responsible for ensuring their selected site meets the following requirements:

• the site is medically supervised and equipped for clinical care, monitoring, medical or behavioural emergencies and emergency resuscitation

• the site has secure storage and record keeping for Schedule 8 medicines as per jurisdictional regulations

• the site has the ability to address treatment-emergent adverse events, with immediate access to rescue medications

• the site is located near (within 15 minutes of) an accredited healthcare facility with an emergency department

• the site has clearly documented treatment plans, consent, and adverse events

• the site adheres to all applicable states and territories requirements

States and territories site requirements

States and territories may have additional site-specific requirements depending on the type of facility and other factors. 

The AP psychiatrist remains responsible for ensuring compliance with all applicable state and territory laws, conditions and approval processes, which may change over time.

See the list of contacts for state/territory medicines and poisons regulation units

C: Clinical justification and evidence for use of the unapproved product

Clinical Treatment Protocols should include:

• demonstrate how all reasonable approved treatment options will be trialled or considered before proposing the use of MDMA or psilocybine. 
• confirm that treatment will only be offered to patients who have unsuccessfully trialled products included in the ARTG for the relevant indication
• provide a declaration that you will discuss the suitability of medical treatment options that are included in the ARTG with the patient before seeking to prescribe psilocybine or MDMA under the AP scheme. 
• a version number to ensure each revision is clearly distinguishable

Provide evidence supporting the use of the MDMA or psilocybine for the intended indication. Include a list of recent peer‑reviewed, published randomised controlled trials demonstrating the efficacy and safety of MDMA and/or psilocybine in the context of psychedelic‑assisted psychotherapy.

D: Product details

You may need to contact the product sponsor, supplier or manufacturer to confirm details of the product you intend to prescribe. List the following specific details of the product:

• active ingredient
• strength (as stated on the product label, not the prescribed dose)
• dosage form (e.g. capsule)
• trade name; and
• manufacturer and sponsor details.

Where available, include product information provided by the sponsor.

Logistics arrangements

To ensure that risks of diversion are identified and mitigated, this section should clearly demonstrate that the full logistics pathway from importation to administration has safeguards in place that meet all regulatory obligations.

Describe how the product will be securely sourced, supplied, stored, and administered. Your description should include:

• importation arrangements (such as, the Australian sponsor importing stock to a compliant warehouse).
• pharmacy supply processes, including: 
  • name of the supplying pharmacy
  • location and proximity to the treatment site
  • dispensing and delivery arrangements (such as, medicine ordered by the pharmacy and delivered directly to the AP psychiatrist).
• storage arrangements, such as secure storage in accordance with states and territories Schedule 8 requirements.
• handling and administration process, including confirmation that the product will be administered only by the AP or other authorised health practitioner, under the supervision of the AP psychiatrist, as required by jurisdictional regulations.

Quality requirements

This section requires a declaration of quality requirements only. However, you should ensure that the sponsor can provide satisfactory evidence of these requirements upon request by the TGA.

• Declare that the product complies with the relevant Therapeutic Goods Order (TGO) 112 or 113, which outline the minimum quality standards for MDMA and psilocybine (see: Complying with the quality requirements for MDMA and psilocybine). 
  • You should be aware that the import, export and supply of medicines that do not comply with a relevant standard is an offence. These provisions apply to everyone in the supply chain, not just the sponsor. 
• Declare that the product is manufactured in accordance with the relevant principles of good manufacturing practice (GMP). GMP describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality. 
  • Australian based manufacturers of medicines and biologicals are required to hold a licence to manufacture. Otherwise, products manufactured at GMP licensed sites are strongly preferred. 

E: Use and monitoring

You must:

• clearly define the specific clinical indication for which the unapproved product will be used
• describe how concomitant medications will be managed, including contraindicated treatments and tapering or ‘washout’ plans required
• outline the full dosing approach, including:
  • the dose to be administered
  • the number of dosing sessions planned
  • any relevant timing or spacing between sessions
• describe the monitoring protocol during and after dosing sessions, including monitoring vital signs, anxiety and mental state 
• list rescue medications that will be kept on-site and the indication they will be used for (such as for anxiety, agitation, hypertension or psychotic symptoms)
• describe how efficacy will be assessed, including a list of outcome measures that will be used. RANZCP provides guidance with suggested assessment scales to use. If scales other than the RANZCP guidance are used, you will need to provide justification for their use
• describe how completion of therapy will be determined, how long-term follow-up will be managed (such as the interval between sessions and how many) and who will be responsible for this (such as the AP psychiatrist, the patient’s usual psychiatrist, delegation to a clinical registry with patient consent).

F: Efficacy and safety

Detail the product’s efficacy and expected benefits.

Include known or expected adverse effects and risks, and how these will be managed, including but not limited to management of patient anxiety and vulnerability, safety measures and related toxicology. 

G: Participant selection and withdrawal

Describe the screening process for eligibility and include a list of inclusion and exclusion criteria. You will also need to outline a clear withdrawal process for patients. 

The AP psychiatrist is responsible for conducting real-time patient screening. Where other screening options are proposed, advice from Ahpra should be included, given the vulnerability of this patient group.

H: Consent process

Provide a clear description of the informed consent process, noting that:

• The AP psychiatrist is solely responsible for obtaining initial and ongoing informed consent, through real time face to face consultation.
• Informed consent must not be delegated to other staff.
• The AP psychiatrist must be present for any dosing sessions.
• Patients should be offered regular support throughout the screening and consent process, preferably face to face. Where non-face-to-face support is proposed, this should be clearly justified.

Include a copy of the patient information and consent form, which must include, but is not limited to:

• Purpose of treatment and what participation involves
• Risks associated with the medicine and risks during dosing sessions
• A financial consent statement
• Details of consent regarding video‑recording, where applicable
• A clear declaration that the product is unapproved, for example: “The product is an unapproved therapeutic good and not included in the ARTG. I understand that the TGA has not assessed the quality, efficacy or safety of the product.”

The form must reflect transparent, patient‑centred communication and support fully informed decision‑making.

I: Psychotherapy and dosing sessions

Provide a detailed description of the preparation, medication administration (dosing), and integration sessions. This must include:

• A full schedule of sessions, including:
  • the number of preparation, dosing, and integration sessions
  • the intervals between each session
  • the format and structure of each session
• A clear explanation of how each session will be conducted, including therapeutic approach, setting, and required personnel.

Face‑to‑face sessions are the expected standard of care. If non-face-to-face sessions are proposed advice on the suggested approach should be discussed with Ahpra.

You must also clearly state that:

• Patients will not have access to MDMA or psilocybine at any time outside the supervised dosing sessions.
• All administration of the MDMA or psilocybine will occur under the direct supervision of the AP psychiatrist, in line with safety and regulatory requirements.

J: Supporting therapists and oversight

The psychedelic‑assisted psychotherapy team (the therapy team) must comprise at least 2 members. 

All members of the therapy team must:

• have psychedelic-assisted psychotherapy within their scope of practice; and
• demonstrate appropriate skills, training and competence relevant to the therapy

One member of the therapy team must hold registration with one of the following National Boards:

• Psychology Board with endorsement as a clinical psychologist 
• Medical Board with general registration
• Nursing and Midwifery Board with mental health experience
• Occupational Therapy Board 

National Boards (through Ahpra) provide legally enforceable standards, mandatory education, professional conduct requirements, CPD, and indemnity insurance. Ahpra can also investigate complaints, impose conditions, suspend or deregister practitioners. This regulatory structure provides strong clinical governance and protection for vulnerable patients.

The AP psychiatrist must ensure that the qualifications and experience of all members of the therapy team are appropriate.

Authorised Prescriber oversight

The AP psychiatrist must be present in-person during the administration of the psychedelic (this does not need to be the full dosing day). This ensures the AP psychiatrist can manage any immediate issues and severe adverse events that may occur. 

This aligns with state/territory Schedule 8 psychedelic handling requirements that prohibit direct dispensing of psychedelic medicines to patients or other therapists and require the prescriber to maintain custody and oversight of the medicine. Additionally, some jurisdictions do not allow administration of the psychedelic medicine to be delegated to another health practitioner. 

The TGA expects strict screening, monitoring, dose control and prevention of diversion due to the vulnerability of patients and until further data is available to demonstrate the safety risks.

The AP is responsible for all patient screening, including obtaining written informed consent, and must remain involved in the overall assessment and ongoing psychotherapeutic management of the patient.

Clinical Treatment Protocol changes

The AP psychiatrist must ensure that any amendments to an approved clinical treatment protocol are submitted to, and reviewed by, the HREC before they are submitted to the TGA.

The AP psychiatrist must explicitly name, and version all updated protocols, ensuring each revision is clearly distinguishable to facilitate efficient updates and document control.

While all changes to a protocol must be notified to the TGA, a new TGA approval is not generally required unless the amendment affects legislative requirements or details in the original approval letter. 

Examples of amendments that do not require a new TGA approval include:

• change of product supplier

• updates to supporting therapists

• adjustments to the psychotherapy schedule

• updates to the list of rescue medications

• addition or removal of a site location

The TGA delegate will review any amendments only for regulatory alignment with expectations; the TGA does not issue formal approval letters for clinical treatment protocol amendments. Once the TGA delegate confirms acceptance of the amendment, a confirmation email will be sent to the AP.

Additional sites

When adding a new site where treatment will occur:

• the site must be reviewed for suitability by TGA delegates, as would be done for a new application.
• if the new site is already approved by the same HREC and is located within the same state or territory, no new TGA approval is required.

Note: When a site change is submitted, the TGA will record the update internally, but only the original site will appear in the external online system.

If treatment is delivered across sites covered by different HRECs (e.g. one hospital HREC, one private HREC):

• separate HREC approvals are required for each site.
• APs must report patient numbers separately for each HREC approval.

Applications following expiry of a MDMA or psilocybine AP approval

AP psychiatrists are responsible for monitoring the expiry date of their TGA approval and should allow sufficient time to submit a new application prior to expiry. 

The TGA recommends that a subsequent application process commence at least 3 months prior to the expiry of the TGA authorisation. 

Subsequent applications must be entered into the SAS and AP online system as per the previous AP approval. The AP psychiatrist must align with the requirements outlined in the Checklists for prescribing psychiatrists of MDMA or psilocybine.

Subsequent applications must include:

• A complete clinical treatment protocol including a declaration summarising any changes to the previously approved protocol.
• All required supporting documentation as detailed in the checklist.
• A new HREC approval.

Detailed information on applying for HREC approval is available on our website at Authorised Prescriber Scheme Guidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors.

To prescribe MDMA and psilocybine, psychiatrists must have obtained approval to use the substances for treating these conditions from a HREC that is registered with the National Health and Medical Research Council (NHMRC).

A list of registered ethics committees is available on the NHMRC website.

The TGA does not specify a template for HREC applications as each committee has its own review processes. If required a suggested template for HREC approval letters is available at Providing approval or endorsement. 

The HREC approval must be current, valid, and not forward‑dated. HRECs may wish to consider in their approval that TGA AP authorisation letters are only valid for a period of 24 months from the date of HREC-approval after which time the AP will need to provide a new HREC approval to the TGA.

Part 4: Complete an authorised prescriber application

The TGA will only consider applications made under the AP Scheme for:

• MDMA for post-traumatic stress disorder, and 
• psilocybine for treatment-resistant depression 

Following approval from a HREC, submit an application to the TGA, through the AP standard pathway using the SAS and AP Online System. 

The clinical treatment protocol, patient information and consent form, and HREC approval are all required to be uploaded with the application.

TGA decision

A delegate of the Secretary of the Department of Health, Disability and Ageing - who is registered as a medical practitioner (a medical officer) – is responsible for reviewing Authorised Prescriber applications for MDMA and psilocybine.

Assessment process

• The TGA delegate assesses each application against all criteria outlined in the TGA’s Checklist for prescribing psychiatrists of MDMA or psilocybine.
• If the application is incomplete or deficient, the TGA will issue a request for information (RFI) letter to the applicant.
• All correspondence relating to the application is directed to the AP psychiatrist unless explicit permission is granted (via email to Authorised.Prescribers@health.gov.au) for correspondence with another party.

Approval

• An AP authority approval letter will be sent to the AP psychiatrist directly by email.
• AP authority approvals are typically granted for a duration of 24 months.
• The approval period generally aligns with 24 months from the date of HREC approval.

Conditions of approval 

• All AP authority approvals are subject to standard (general) conditions. 
• The TGA may impose additional, specific conditions on a case-by-case basis.
• The approving HREC may also set conditions to the approval.

Post-approval requirements

• Once approved, the AP psychiatrist may prescribe the unapproved good to a patient under their direct care.
• AP psychiatrists must comply will all approval conditions to maintain their authorisation.

Non-compliance

Failure to comply with conditions of authorisation may result in the revocation of the Authorised Prescriber's status.

The Poisons Standard is given legal effect through relevant State and Territory drugs, poisons and controlled substances legislation, which governs access to and supply of medicines and poisons within each jurisdiction.

Psychiatrists must prescribe MDMA and psilocybine in accordance with the legislative requirements of their State or Territory. Requirements may vary between jurisdictions and must be carefully followed.

Psychiatrist applicants are strongly advised to consult their State and Territory Health Departments prior to submitting an application under the AP scheme. This ensures:

• Correct interpretation of the Poisons Standard
• Compliance with legal requirements for the supply and prescribing of MDMA and psilocybine within their State or Territory. 
• Certain states and territories also have specific requirements regarding treatments sites which may include licensing and accreditation depending on the type of facility and treatment setting. 

Information sharing - personal information of the applicant (medical practitioner) and the outcome of the application, including the TGA decision letter may be disclosed to state and territory authorities with responsibility for therapeutic goods regulation and/or health practitioner registration.

Reporting requirements

Six monthly AP reporting

It is a condition of the AP scheme that medical practitioners provide supply reports on the number of patients treated for each of their AP authority approvals for the periods:

• 1 January to 30 June, and 
• 1 July to 31 December each year.

Reports must be submitted to the TGA as soon as practicable at the end of the reporting period and no later than 1 month after the reporting period closes.

There are two categories to report:

• Number of new patients commenced on treatment
• Number of total patients treated during this period.

To submit your authorised prescriber six monthly reports, go to the SAS and AP Online System.

Follow the AP six‑monthly reporting user guide when completing and submitting AP reports.

If no patients have been treated in the relevant period, this must also be reported. 

Information on using the online portal system to submit six monthly reports is found in the Authorised Prescriber online system.

Reporting adverse events and product defects

MDMA and psilocybine have not been evaluated for safety, quality and efficacy and could pose unknown risks. Authorised Prescribers are responsible for reporting adverse events or product defects.

Detailed instructions on reporting adverse events and product defects, are available on the TGA website under: Reporting adverse events.

Supply and handling requirements

Authorised Prescribers are responsible for organising supply of the product. This may be through an Australian sponsor or by sourcing the product from overseas. 

Read more about how to supply, manufacture or import MDMA or psilocybine (sponsors and manufacturers).

See the Office of Drug Control’s website, Access to MDMA or Psilocybine for requirements relating to importing MDMA and psilocybine for use by an Authorised Prescriber.

Ensuring legal supply

An AP psychiatrist is permitted to supply MDMA or psilocybine only to specified patients under their direct and immediate care. The AP psychiatrist must not supply MDMA or psilocybine to other practitioners for prescribing or administration.

The use of the MDMA or psilocybine must always be:

• Consistent with the authorisation granted, and
• In full compliance with any conditions specified in the authorisation.

AP psychiatrists must comply with all State and Territory regulations regarding:

• Storage
• Handling
• Supply of Schedule 8 psychedelic products.

Where necessary, arrangements may include:

• Engaging a pharmacy to securely hold the product on behalf of the AP psychiatrist
• Ensuring secure transfer to the AP psychiatrist when required for administration to the patient.

Schedule classification considerations

In some jurisdictions, MDMA and psilocybine may be classified as Schedule 9 (Prohibited Substances) at certain points in the supply chain.

This may trigger additional requirements including:

• Special licences

• Approvals from State or Territory health departments. 

Safety considerations

The TGA cannot provide an assurance regarding the quality, safety or efficacy of unapproved therapeutic goods. All parties involved in the supply of unapproved therapeutic goods must recognise that the practice may carry medico-legal risk, and, in the case of a company, there may be implications for the company's indemnity.

In prescribing an unapproved product containing MDMA or psilocybine for a patient, psychiatrists are responsible for considering the benefits and risks for the patient. AP psychiatrists should remain informed of changes to the benefits and risks as they arise.

Cost

MDMA and psilocybine are unapproved therapeutic goods and are not eligible for listing on the Pharmaceutical Benefits Scheme (PBS). 

Treatment costs must be met by the patient or a third party.

All advertising of therapeutic goods in Australia is regulated under the TG Act and the Therapeutic Goods Advertising Code (the Code).

Prohibition on public advertising

Prescription medicines and all unapproved therapeutic goods, including those containing MDMA and psilocybine, are prohibited from being advertised to the public.

AP psychiatrists must not promote, either expressly or implicitly: 

• The use, or
• The availability or supply
  of MDMA or psilocybine in any materials accessible to the public.

This includes: 

• Websites
• Social media
• Marketing materials

It is therefore unlawful for practitioners or healthcare facilities to indicate that they can prescribe or supply these substances.

Significant penalties apply for non-compliance.

Advertising to health professionals

MDMA and psilocybine may be advertised only to health professionals, such as: 

• Psychiatrists
• Pharmacists

Advertising must comply with TGA guidance on advertising exclusively to health professionals.

Exclusions from advertising rules

The following are not considered advertising:

• Information shared privately between a health practitioner and their patient during consultation or treatment
• Factual, balanced, and non-promotional information presented in: 
  • Scientific publications
  • Medical conferences
• However, if content could reasonably be interpreted by the public as promotional, it will be subject to advertising restrictions.

Refer to the Regulation of therapeutic advertising in Australia for further information.

Clinical Trials

Access to MDMA and psilocybine remains restricted for all indications other than:

• Post-traumatic stress disorder (PTSD) (for MDMA), and
• Treatment-resistant depression (TRD) (for psilocybine)

For all other indications, these substances remain classified as Schedule 9 (Prohibited Substances) under the Poisons Standard, limiting their use to medical and scientific research, including clinical trials.

Information about how TGA regulates clinical trials is on our website at Clinical trials.