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Authorised Prescribers: MDMA for PTSD and Psilocybin for Treatment Resistant Depression

HomeResearchAuthorised Prescribers: MDMA for PTSD and Psilocybin for Treatment Resistant Depression

Authorised Prescribers: MDMA for PTSD and Psilocybin for Treatment Resistant Depression

On this page:

  • Overview
  • Eligibility
  • Application Process
  • Six Monthly Reporting Process
  • Authorised Prescriber Approval Renewal
  • Forms
  • TGA and HREC Adverse Event Reporting (MDMA & Psilocybin)
  • Further Information and Guidance Documents

OVERVIEW

On 1 July 2023, the Therapeutic Goods Administration (TGA) amended the Poisons Standard in relation to MDMA and psilocybin, adding them to Schedule 8 and permitting their use as Controlled Drugs only for the treatment of PTSD (MDMA) and treatment-resistant depression (psilocybin). For all other indications, MDMA and PTSD remain on Schedule 9 of the Poisons Standard. Since MDMA and psilocybin are not medicines registered on the Australian Register of Therapeutic Goods (ARTG), that is they are unapproved therapeutic goods, they may only be prescribed by Authorised Prescribers to specified patients with a particular medical condition under their immediate care. Such Authorised Prescribers must be authorised under the TGA’s Authorised Prescriber Scheme.

In order to become an authorised prescriber of MDMA for PTSD and/or psilocybin for treatment-resistant depression, eligible practitioners must:

  1. Obtain approval of a Human Research Ethics Committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC), AND THEN
  2. Obtain authorisation by the TGA under the TGA’s Authorised Prescriber Scheme to prescribe MDMA for PTSD and/or psilocybin for treatment-resistant depression

ELIGIBILITY
Who is Eligible to Become an Authorised Prescriber of MDMA for PTSD and Psilocybin for Treatment Resistant Depression?

Under the changes to the scheduling of psilocybin and MDMA, only psychiatrists who are: 1) registered with the Australian Health Practitioner Regulation Agency (AHPRA) AND 2) Fellows of the Royal Australian and New Zealand College of Psychiatry (RANZCP) are eligible to apply to become Authorised Prescribers of MDMA for PTST and psilocybin for treatment-resistant depression under the TGA’s Authorised Prescriber Scheme.

APPLICATION PROCESS

NIIM has a Policy and Procedures (below) that set out the principles and processes for applications by registered psychiatrists to become Authorised Prescribers of MDMA for PTSD and/or psilocybin for treatment-resistant depression under the TGA’s Authorised Prescriber Scheme.

Application Form

Applicants must complete and submit the appropriate application form(s), including required attachments (Treatment Protocol, Informed Consent Form):

There are separate forms (and payments) for MDMA and psilocybin. Note that applicants must ensure that they complete the Application Checklist and have appended all required documents when they submit their application. Any incomplete applications will be returned to the applicant for completion prior to being assessed by the HREC.

Where Do I Send My Application?
Applications should be emailed to:
Email: aps@niim.com.au

The NIIM HREC meets every two (2) months. You need to ensure that you lodge your APS PAT application form 4 weeks prior to the HREC meeting date.

NIIM HREC Meeting Dates 2024

Date of Meeting:                          Deadline for lodgement of APS PAT applications: 
13/02/2024                                       16/01/2024
02/04/2024                                       05/03/2024
04/06/2024                                       07/05/2024
06/08/2024                                       09/07/2024
01/10/2024                                        03/09/2024
26/11/2024                                        29/10/2024

What Happens Next?
Applications are assessed by the NIIM HREC in accordance with the NIIM HREC Authorised Prescriber Scheme (Psychedelic Medicines) Application Approval Policy and Procedures. On submission of your application form, you will be emailed an invoice for the Application Fee (see below).
If you are successful, you will be emailed a HREC approval letter that will form part of your final step in applying for Authorised Prescriber approval- your application to the TGA. Note that approval letters will not be issued until payment of the application fee is received.

Application Fee
The application fee for assessment of a new application is $1,500 and for a renewal or amendment $750. An invoice will be raised when the application is received. Approval letters will not be issued where payment has not been received.

Final Approval: Apply to the TGA
Once you have received your HREC approval letter, you must then apply to the TGA for final approval to be an Authorised Prescriber through the standard pathway. The TGA grants final approval of Authorised Prescriber status (not the HREC). To apply, submit the TGA application form via the online system: www.compliance.health.gov.au/sas/

What If I’m Not Successful?
Should your application not be successful, you will have the opportunity to resubmit your application, addressing any of the concerns of the HREC.
You also have the right to appeal the HREC decision. See the NIIM HREC Authorised Prescriber Scheme (Psychedelic Medicines) Application Approval Procedures for further information.

SIX MONTHLY REPORTING REQUIREMENTS
TGA 6 monthly reports

As required by the TGA, it is a condition of the Authorised Prescriber Scheme that authorised prescribers complete 6 monthly reports for the periods of 1 January to 30 June and 1 July to 31 December each year. See the TGA website for reporting requirements. Reports can be submitted through the SAS & Authorised Prescriber Online System.

NIIM HREC 6 monthly reports

The NIIM HREC also requires completion of a 6 monthly report using the NIIM 6 monthly reporting template. In addition, as for any drug, adverse reactions associated with the unapproved good(s) must be reported to the TGA with a copy submitted to the NIIM HREC. Email these to: aps@niim.com.au

AUTHORISED PRESCRIBER APPROVAL RENEWALS

HREC approval for MDMA and psilocybin is for 12 months only. Applicants who have gained approval from the NIIM HREC must reapply for Authorised Prescriber approval, including submitting evidence of completion of continuing professional development (CPE) in relation to the unapproved good. See NIIM HREC Authorised Prescriber Scheme (Psychedelic Medicines) Application Approval Procedures for further information.

FORMS

 

TGA AND HREC ADVERSE EVENT REPORTING (MDMA AND PSILOCYBIN)

As required by the TGA, authorised prescribers must submit reports of any adverse events to the TGA within specified time periods. See the TGA website: Home – Adverse event reporting (tga.gov.au)
A copy of the adverse event report should also be submitted to the NIIM HREC.

FURTHER INFORMATION AND GUIDANCE DOCUMENTS

Therapeutic Goods Administration

  •  TGA Website providing guidance on prescribing of MDMA and psilocybin: www.tga.gov.au/products/unapproved-therapeutic-goods/mdma-and-psilocybin
  • TGA Access to MDMA (3,4-methylenedioxy-methamphetamine) and psilocybin for therapeutic purposes-information for psychiatrist prescribers Available at URL: www.tga.gov.au/resources/resource/guidance/access-mdma-34-methylenedioxy-methamphetamine-and-psilocybin-therapeutic-purposes-information-psychiatrist-prescribers
  • TGA Reporting of Adverse Events: www.aems.tga.gov.au

Royal Australian and New Zealand College of Psychiatrists

  • RANZCP Psychedelics Webpage/Hub Available at URL: www.ranzcp.org/clinical-guidelines-publications/in-focus-topics/psychedelics
  • Clinical Memorandum: Therapeutic Use of MDMA For PTSD and Psilocybin for Treatment Resistant Depression Available at URL: www.ranzcp.org/clinical-guidelines-publications/clinical-guidelines-publications-library/therapeutic-use-of-mdma-for-ptsd-and-psilocybin-for-treatment-resistant-depression