​​​​An approval from the ºÚÁϳԹÏÍø Ministry of Health is required to prescribe or supply intranasal esketamine or injectable ketamine for treatment resistant depression (TRD) to:
Note: an 'approval' is a reference to an authority under the Poisons and Therapeutic Goods Act 1966. An approval issued to a prescriber by the ºÚÁϳԹÏÍø Ministry of Health is separate to the authority required from Services Australia for a patient to receive a Commonwealth PBS subsidised medicine.
Esketamine and ketamine medicines are to be administered under direct medical supervision, in a healthcare setting which has established administration and patient monitoring procedures and protocols. This setting must be equipped to manage any behavioural and/or medical emergencies.
Only Ahpra registered psychiatrists can apply to prescribe or supply intranasal esketamine or injectable ketamine for TRD​ .
Medical practitioners who are not Ahpra registered psychiatrists must refer the patient to a psychiatrist for prescribing and supply of esketamine or ketamine for TRD.
From 01 April 2025, Ahpra registered psychiatrists are authorised under a class authority to prescribe or supply the Australian Register of Therapeutic Goods (ARTG) registered esketamine (Spravato®) nasal spray for the treatment of TRD in a non-drug dependent person over the age of 18 years. The clas​s authority can be used to prescribe up to a maximum daily dose of 84mg.
This means that psychiatrists will not need to apply to the ºÚÁϳԹÏÍø Ministry of Health for an approval for an individual patient in these circumstances.
Psychiatrists must still apply for an individual patient approval to prescribe or supply intranasal esketamine, where required, in all other circumstances.
Ahpra registered psychiatrists must submit an application for an individual patient approval, where required, to prescribe or supply injectable ketamine for the treatment of TRD.
Applications for an approval to prescribe or supply esketamine or ketamine should be submitted by an Ahpra registered psychiatrist via the SafeScript ºÚÁϳԹÏÍø portal.
Applications via SafeScript ºÚÁϳԹÏÍø will provide real-time approval in many cases or a no​tification if the application needs to be reviewed by the ºÚÁϳԹÏÍø Ministry of Health.
Alternatively, an Application for Approval to Prescribe or Supply a Schedule 8 Medicine – Esketamine or Ketamine for Treatment Resistant Depression may be submitted to Pharmaceutical Services​