Mind Medicine Australia Final Update On How To Submit To TGA On Psilocybin & MDMA Medicinal Use & Re-Scheduling

This 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 depression, PTSD 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. The changes proposed by Mind Medicine Australia will not affect existing legal controls on illicit use or supply.

With only a short time left, we are inviting you to support our applications for the rescheduling of these two medicines by lodging your ownsupporting submissions with the TGA no later than Monday 28 September 2021. The rescheduling of these medicines would be a historic moment for all of us!

Why is Rescheduling so Important?

1. To Expand the Medical Treatment Paradigm in Australia in a Major Way. Rescheduling will enable psychiatrists and specialist addiction physicians to more easily access these medicines for patients suffering from key mental illnesses. It relieves a significant part of the regulatory burden associated with undertaking trials with these medicines in Australia.
2. To Educate Australians. To educate all key stakeholders in our medical system (e.g. medical practitioners, other health workers, politicians, regulators, people suffering from mental illness and other members of the general public) that these substances can be used positively and safely in a medically controlled environment to broaden the treatment paradigm for mental illnesses in Australia and substantially reduce the incidence of mental illness in our community.
3. To Remove Stigma. To help the general community understand that the prohibition of psychedelics was politically motivated by a disgraced President of the United States (President Nixon), was not based on any scientific or medical rationale, and that the failure of our system to recognise that these substances can be used effectively as medicines in a medically controlled environment is detrimental to the health and welfare of a huge number of Australians.

Key Dates:

• Monday 28 September 2020 – The final date for making a submission. Our rescheduling applications and the public submissions will then be reviewed by the TGA’s expert committee.
• Wednesday 3 February 2021 – The Expert Committee’s interim decision on our rescheduling applications is published. There will then be a further period open for public submissions.
• Thursday 4 March 2021 – Closing date of second round submissions limited to people/organisations that lodged submissions during the earlier period.
• Thursday 22 April 2021 – Publication of Final Decision.

How to Write a Submission?

How to Lodge a Submission?