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The requirements for Medicinal Cannabis can be found at Accessing medicinal cannabis for a patient.
The requirements for MDMA and psilocybine can be found at Prescribe MDMA or psilocybine (psychiatrists).Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG).
This must be done before they can be legally supplied, imported to or exported from Australia.
Products not included in the ARTG are referred to as unapproved therapeutic goods.
If conditions are met, you can apply to access unapproved therapeutic goods.
How to apply
This will depend on whether you want access to an unapproved therapeutic good for:
- an individual patient on a case-by-case basis
- multiple patients with the same condition.
To apply for an individual patient, use the Special Access Scheme (SAS).
For multiple patients with the same condition, use the Authorised Prescriber (AP) Scheme.
If you need help to decide what pathway is right for you, try the accessing unapproved therapeutic goods tool.
- Access for individual patients (Special Access Scheme)
- Access for multiple patients (Authorised Prescriber)
Who can apply
You must be registered by the Australian Health Practitioner Regulation Agency (AHPRA) to be listed as the prescriber.
Use the searchable table to determine if you are eligible to access an unapproved good using the SAS and AP pathways.
These requirements relate to the prescriber details in submissions. In some cases, another health practitioner may be able to submit the form on behalf of the prescriber.
| Practitioner Type | Registration Type | SAS A | SAS B | SAS C | Submit SAS on behalf | AP Established History of Use | AP Standard | Key notes |
|---|---|---|---|---|---|---|---|---|
| Medical Practitioner | General and Limited | Yes | Yes | Yes | Yes | Yes | Yes | SAS B medicinal cannabis - Medical practitioner can access medicinal cannabis for under 18's with a letter of endorsement from a paediatrician or other relevant specialist. SAS C – Only where medical practitioner is listed on SAS Category C list. AP - Not eligible to access medical device products. |
| Medical Practitioner | Specialist | Yes | Yes | Yes | Yes | Yes | Yes | SAS C – Only where medical practitioner is listed on SAS Category C list. AP - Only Psychiatrists can apply to access psychedelics. AP medicinal cannabis - Only a paediatrician or other relevant specialists can access medicinal cannabis Category 2-5 for under 18's |
| Medical Practitioner | Provisional | Yes | Yes | Yes | Yes | No | No | SAS C – Only where medical practitioner is listed on SAS Category C list. AP - Not eligible. |
| Nurse Practitioner | General | No | Yes | Yes | Yes | No | No | SAS B medicinal cannabis - Only can access medicinal cannabis if evidence can be provided that it's within their scope of practice. SAS C – Only where nurse practitioner is listed on the SAS Category C list. |
| Dental Practitioner | General, Specialist | No | Yes | Yes | Yes | No | No | SAS C – Only where dental practitioner is listed on the SAS Category C list |
| Optometrist | General | No | Yes | No | Yes | No | No | SAS B - May apply to access topical schedule 2,3 and 4 medicines from the Board approved scheduled medicines list for endorsed optometrists. |
| Pharmacist | General, Provisional | No | Yes | Yes | Yes | No | No | SAS B - May apply to access schedule 2 and schedule 3 medicines. SAS C – Only where pharmacist is listed on the SAS Category C list. SAS and AP – Unable to access medicinal cannabis. |
| Practitioners (All other practitioners e.g., Nurse, Midwife, Medical Radiation Practitioner, etc.) | General, Provisional | No | No | No | Yes | No | No | Practitioners in this category are not eligible to be listed as the prescriber. However, you may submit SAS notifications or applications on behalf of the prescribing practitioner. |
Student and non-practising registration types are not eligible to access an unapproved therapeutic good.
Conditions on any registration type may affect eligibility to access an unapproved therapeutic good.
Medical practitioners
As a registered medical practitioner, you can apply to access unapproved therapeutic goods for:
- individual patients on a case-by-case basis through the Special Access Scheme
- multiple patients with the same condition as an Authorised Prescriber.
Other health practitioners
- You may be able to use the SAS pathways to submit on behalf of a medical practitioner or
- apply to access unapproved therapeutic goods for individual patients as a registered health practitioner.
You can’t become an Authorised Prescriber. This is only available to medical practitioners.
You must be the named practitioner on the TGA notification or approval letter to be authorised to access the unapproved therapeutic good.
Due to an agreement with the States and Territory Health Departments, SAS submissions for medicinal cannabis products, should be made by the prescribing health practitioner.
Read how to access unapproved products for individual patients (Special Access Scheme).
Who can't apply
You can’t apply to access unapproved therapeutic goods if you:
- have conditions on AHPRA registration limiting authority to prescribe the specific unapproved therapeutic good
- hold non-practising registration
- hold student registration
- are not an AHPRA registered health practitioner
- are a non-health practitioner, sponsor or patient.
What you can access
As a practitioner, you are best placed to determine the needs of your patient.
This includes treatment with an unapproved therapeutic good.
You can apply to access any unapproved therapeutic good within your scope of practice that will benefit your patient. This includes:
You can’t apply to access therapeutic goods in Schedule 10. Please speak with your State or Territory Health Authorities before making an application to access any product in Schedule 9.
Before you apply
Before you apply to access an unapproved therapeutic good, you should:
- consider approved therapeutic goods for your patient's medical condition
- consider risks of treatment
- obtain informed consent
- adhere to relevant standards of good medical practice
- check state and territory requirements
- check the unapproved therapeutic good is available and affordable for the patient.
Consider approved therapeutic goods for your patient's medical condition
Before you apply to access an unapproved therapeutic good, you must consider treatment options included in the Australian Register of Therapeutic Goods.
You can apply to access unapproved therapeutic goods to patients who are not responding to standard approved treatments.
You must have appropriate knowledge of:
- the condition being treated
- the unapproved therapeutic good.
The intended use of the unapproved therapeutic good must be within your scope of practice.
Consider risks of treatment
You must consider the risks of using an unapproved therapeutic good before prescribing it.
We haven’t evaluated unapproved therapeutic goods for:
- quality
- safety
- efficacy
- performance.
You can refuse to prescribe if you believe there is insufficient clinical justification or evidence to support the use of an unapproved therapeutic good.
You are responsible for the use of an unapproved therapeutic good and all outcomes. This includes adverse reactions.
Obtain informed consent
You must obtain the informed consent of your patient or their legal guardian before prescribing unapproved therapeutic goods.
You should record your patient’s consent in their medical record or patient file.
You don't need to send proof of your patient's consent to us.
Read more about informed consent.
Adhere to relevant standards of good medical practice
You are expected to adhere to relevant standards of good medical practice in the treatment of patients.
Medical practitioners
You must operate in accordance with principles outlined by the Medical Board of Australia.
Read good medical practice: a code of conduct for doctors in Australia.
Other health practitioners
Refer to your appropriate governing body for guidance.
Check state and territory requirements
You may also need to meet state and territory requirements to prescribe unapproved therapeutic goods.
To find out more contact your state or territory drug and poisons regulation unit.
Check the unapproved therapeutic good is available and affordable for the patient
You should check with the supplier to ensure they can supply the unapproved therapeutic good.
The price of an unapproved therapeutic good is determined by the supplier.
Unapproved therapeutic goods are not subsidised through the Pharmaceutical Benefits Scheme (PBS).