Schedule 8 MDMA and Schedule 8 psilocybine

MDMA and psilocybine FAQ for psychiatrists and other medical practitioners

• I am a psychiatrist with TGA Authorised Prescriber approval to prescribe MDMA for PTSD. What do I need to do in Victoria?

  You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering MDMA for PTSD to your patient. The notification is substance specific, doctor specific and patient specific. This means, for every patient that you intend on prescribing MDMA for PTSD, you are required to submit a notification in respect of that patient.

  The notification form can be found here.

  Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health.

  If you have reason to believe your patient to be drug-dependent, you must apply and hold a Schedule 8 permit for MDMA prior to prescribing or administering MDMA, in addition to making the above notification.

  The notification form should only be completed by psychiatrists with TGA Authorised Prescriber approval for MDMA.

• I am a psychiatrist with TGA Authorised Prescriber approval to prescribe psilocybine for treatment-resistant depression. What do I need to do in Victoria?

  You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering psilocybine for treatment-resistant depression to your patient. The notification is substance specific, doctor specific and patient specific. This means, for every patient that you intend on prescribing psilocybine for treatment-resistant depression, you are required to submit a notification in respect of that patient.

  The notification form can be found here.

  Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health.

  If you have reason to believe your patient to be drug-dependent, you must apply and hold a Schedule 8 permit for psilocybine prior to prescribing or administering psilocybine, in addition to making the above notification.

  The notification form should only be completed by psychiatrists with TGA Authorised Prescriber approval for psilocybine.

• I am a medical practitioner engaged in a clinical trial for MDMA for PTSD. What do I need to do in Victoria?

  You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering MDMA for PTSD to the trial participant. The notification is substance specific, doctor specific and participant specific. This means, for every patient that you intend on prescribing MDMA for PTSD, you are required to submit a notification in respect of that participant.

  The notification form can be found here.

  Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health.

  If you have reason to believe your participant to be drug-dependent, you must apply and hold a Schedule 8 permit for MDMA prior to prescribing or administering MDMA, in addition to making the above notification.

  The notification form should only be completed by medical practitioners engaged in clinical trials for MDMA for PTSD.

• I am a medical practitioner engaged in a clinical trial for psilocybine for treatment-resistant depression. What do I need to do in Victoria?

  You need to notify the Victorian Department of Health at least 7 days prior to prescribing or administering psilocybine for treatment-resistant depression to the trial participant. The notification is substance specific, doctor specific and participant specific. This means, for every patient that you intend on prescribing psilocybine for treatment-resistant depression, you are required to submit a notification in respect of that participant.

  The notification form can be found here.

  Once you have completed and submitted the notification form, you do not need to wait for permission or acknowledgement from the Victorian Department of Health.

  If you have reason to believe your participant to be drug-dependent, you must apply and hold a Schedule 8 permit for psilocybine prior to prescribing or administering psilocybine, in addition to making the above notification.

  The notification form should only be completed by medical practitioners engaged in clinical trials for psilocybine for treatment-resistant depression.

• I have submitted a notification form for one of my patients but details associated with that notification have now changed. I have not yet prescribed for or administered to my patient. Is there anything I need to do?

  If you have already submitted a notification form for your patient but details associated with this notification have changed or are no longer correct, you are required to submit a new notification with the updated details. These changes could include a change of drug supplier, dose, or anticipated administration date/s, and all require a new notification form to be submitted.

• How long is my notification valid for? How frequently do I need to notify the Department of Health?

  If you have submitted a notification form, you are not required to submit another notification if details of the notification form have not changed. The notification only applies to the period of treatment as indicated on the notification form. If your patient requires additional dosing sessions, you need to submit another notification.

  For example, if your initial notification states that you intend to prescribe for and dose a patient on 1 August 2023 only, but after the 1 August 2023 you then decide your patient requires another dose after this date, you need to submit a new notification with the second dose date at least seven days before this date.

• What does Local Australian Supplier details mean on the notification form?

  This means the Australian entity from which you are obtaining MDMA or psilocybine. This could be an Australian wholesaler, a community pharmacy, a hospital pharmacy or an Australian manufacturer. If you are importing MDMA or psilocybine directly from an overseas supplier yourself and storing it onsite at your practice/clinic, the local Australian Supplier is your own practice/clinic.

• Who should complete the notification form if there are multiple medical practitioners involved in a clinical trial (not TGA Authorised Prescriber)?

  The notification form is prescriber and participant specific. The medical practitioner who is allocated to prescribe MDMA or psilocybine for a specific participant within a clinical trial should complete and submit the notification form. However, the notifying medical practitioner may authorise:

  Another medical practitioner engaged in the clinical trial to administer MDMA or psilocybine.

  Another nurse or nurse practitioner engaged in the clinical trial to administer MDMA or psilocybine.

  This does not apply to psychiatrists with TGA Authorised Prescriber approval who are prescribing or administering MDMA or psilocybine to patients outside clinical trials. Approved TGA Authorised Prescribers must only administer MDMA or psilocybine directly to specified patients under their immediate care and must not supply to other practitioners to prescribe or administer, as stipulated by the TGA Authorised Prescriber approval requirements.

• I am a psychiatrist and do not have TGA Authorised Prescriber approval to prescribe psilocybine or MDMA. Can I still prescribe psilocybine or MDMA for my patients?

  No, you cannot prescribe psilocybine or MDMA if you do not have TGA Authorised Prescriber approval to do so.

  If you are engaged in a clinical trial of psilocybine for treatment-resistant depression or a clinical trial of MDMA for PTSD and the clinical trial has human research ethics approval and is approved by or notified to the TGA, you can prescribe psilocybine for treatment-resistant depression or MDMA for PTSD for the clinical trial participants – provided you notify the department at least seven days prior to prescribing or administering.

  If you are prescribing psilocybine for an indication other than treatment-resistant depression or prescribing MDMA for an indication other than PTSD, you must apply and hold a Schedule 9 permit prior to prescribing or administering psilocybine or MDMA. Schedule 9 permits are only issued for clinical trials which have been approved by a human research ethics committee.

• I am a clinical trial coordinator for a psilocybine clinical trial. What do I need to do?

  Please see Schedule 9 permits for clinical trials for the process to obtain Schedule 9 permits for clinical trials.

  If the clinical trial is psilocybine for treatment-resistant depression, medical practitioners do not need to apply and hold a Schedule 9 permit. The medical practitioners must submit a notification at least seven days prior to prescribing or administering psilocybine and where there is reason to believe the participant is a drug-dependent person, medical practitioners must also hold a Schedule 8 permit prior to prescribing or administering psilocybine.

• I am a clinical trial coordinator for a MDMA clinical trial. What do I need to do?

  Please see Schedule 9 permits for clinical trials for the process to obtain Schedule 9 permits for clinical trials.

  If the clinical trial is MDMA for PTSD, medical practitioners do not need to apply and hold a Schedule 9 permit. The medical practitioners must submit a notification at least seven days prior to prescribing or administering MDMA and where there is reason to believe the participant is a drug-dependent person, medical practitioners must also hold a Schedule 8 permit prior to prescribing or administering MDMA.

• I am a psychiatrist with TGA Authorised Prescriber approval for both MDMA and psilocybine. What are the requirements for storing MDMA and psilocybine at my medical practice?

  MDMA and psilocybine must be stored and records retained in accordance with the Drugs, Poisons and Controlled Substances Regulations 2017.

  You need to ensure that MDMA and psilocybine products are appropriately stored in secure facilities (i.e. a drug safe) prior to its administration. You are required to maintain appropriate records (i.e. a drug register) in relation to handling of MDMA and psilocybine. Please see further information on storage and recording requirements.