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TGA Rescheduling Submissions

Mind Medicine Australia has submitted Australia’s first applications to Australia’s Therapeutic Goods Administration (TGA) to reschedule psilocybin and MDMA so that they can be more easily used as clinical therapies for the treatment of mental illnesses. The rescheduling would move these medicines from Schedule 9 of the Uniform Scheduling of Medicines and Poisons (which deals with Prohibited Substances) to Schedule 8 (which deals with Controlled Medicines). The changes proposed by Mind Medicine Australia will not affect existing legal controls on illicit use or supply.

The rescheduling will enable psychiatrists and specialist addiction physicians to more easily access these medicines to augment therapy for patients suffering from key mental illnesses such as depressionPTSD and for the depression and anxiety often associated with a terminal illness diagnosis (and hopefully in the future for substance abuse, OCD, anorexia and early stage dementia). It will also relieve a significant part of the regulatory burden associated with undertaking trials with these medicines in Australia.

We are inviting you to support our applications for the rescheduling of these two medicines by lodging your own supporting submissions with the TGA. The rescheduling of these medicines would be a historic moment for all of us!

Key Dates:

  • Wednesday 26th August 2020 – TGA publishes notices seeking submissions on the proposed rescheduling by Friday 25 September.
  • Monday the 28th of September 2020 – The final date for making a submission closing at 5 pm AEST. Following the submission of public comments, the submission will be reviewed by an expert committee.
  • Wednesday the 3rd of February 2021 – An interim decision will be published by the TGA inviting comments from those who made a public submission in the first round.  Therefore, it is important to make a comment in the first round if you would like to comment on the interim decision.
  • Thursday the 4th of March  Submissions for comments on the TGA’s interim decisions close at 5pm AEST.
  • Thursday 22 April 2021 – Publication of notice of the final decision.

How to write a submission?

Please see our simple how-to guide below for making a submission to the TGA.

How to Lodge a Submission?

For your submission to be considered by the expert panel it must be sent to the TGA (through the TGA’s Consultation Portal) by no later than 5pm on Monday the 28th of SeptemberSubmissions lodged after this time will not be considered. If you do not lodge a submission to the TGA during this period, you will not be able to comment on the interim decision on our applications that will be made in November.

Important Resources:

Mind Medicine Australia Submission Guide

Mind Medicine Australia's overview and instruction on how to make your submission to the TGA.

Medicinal Psilocybin Rescheduling Application

Mind Medicine Australia's application to reschedule Psilocybine from Schedule 9 to Schedule 8 of the Poisons Standard 14 July 2020.

Medicinal MDMA Rescheduling Application

Mind Medicine Australia's application to reschedule N, α-DIMETHYL 3,4(METHYLENEDIOXY) PHENYLETHYLAME (MDMA) from Schedule 9 to Schedule 8 of the Poisons Standard 15 July 2020.

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