SAS-B Application

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SAS-B application

Most medicinal cannabis products in Australia are not on the ARTG and therefore require TGA approval to be prescribed. The two primary pathways for doctors to gain TGA approval are through the Special Access Scheme (SAS) under category B, or the Authorised Prescriber Scheme (APS).
SAS-B applications require clinical justification for prescribing medicinal cannabis. This will include information about prior treatments, the patient’s response and why medicinal cannabis would be more appropriate, as well as an outline of the expected benefits for the patient compared with the potential risks.

The APS allows a doctor to prescribe medicinal cannabis to patients with a particular condition. When a doctor has approval as an Authorised Prescriber, they don’t need to submit individual SAS applications for any patients of theirs who has the conditions outlined in their TGA approval. This makes the process of prescribing medicinal cannabis more straightforward and can get medicine into patients’ hands faster.

SAS-B applications require clinical justification for prescribing medicinal cannabis.

cannatrek plus

SAS Applications with Cannatrek Plus

The TGA has an online portal to make SAS-B applications easy to complete. However, Cannatrek is developing an alternative portal, Cannatrek Plus, which will greatly simplify the SAS-B applications process. Once fully operational, Cannatrek Plus will provide doctors a number of benefits:
  1. Patient information and medical history will be pre-supplied and filled to expedite the application process.
  2. Prescriptions, approvals, and medical history for medicinal cannabis patients will all be manageable within the portal.
  3. The toolkit will make product recommendations and supply detail based on the patient’s conditions and indications to assist doctors in prescribing effective treatments.

The entire process of prescribing medicinal cannabis will be radically streamlined with Cannatrek Plus. The SAS-B process can be somewhat onerous using the regular channels and application forms; with Cannatrek Plus, it will be a great deal easier for both doctors and patients. The full toolkit of Cannatrek Plus is still in development, but you can sign up today to keep informed on when it comes online.

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How to submit a SAS category B application

As Cannatrek Plus is currently under development, doctors will need to rely on the TGA’s portal in the meantime. The steps involved in the process are outlined below:
Step 1: Make an account

Go to the SAS portal and click register. You will be asked to enter your details, including a username, email address, password. To complete the registration process you will also need to provide your name, health practitioner type, contact details, and AHPRA number. If users already have online accounts with other TGA systems, they should use those login details instead of registering a new account.


Step 2: Submit application

The application process begins by clicking ‘New SAS Submission’. You will be asked to confirm you are the prescriber and to approve your professional details that will show up based on your profile.

You will then need to search for “Cannatrek” to find the particular medicine you wish to prescribe. You will also need to select or enter the relevant dosage form, and the indication for which you are prescribing the medicine.

You will have option here to submit your application concurrently to the relevant state or territory authority.

Next you will have to enter the dosage and frequency considerations, and patient details which includes the clinical diagnosis relevant to the submission, the clinical justification, and the intended monitoring. If you are not the regular GP of the patient, you will need to contact them to get their opinion on medicinal cannabis as a treatment for the patient. They don’t have to agree with the prescription, but it is a requirement to get their views. A specialist opinion on why medicinal cannabis is a worthwhile therapy may help your application succeed but it is not required. You will still need to provide your own clinical justification for seeking medicinal cannabis as treatment.

If the product you are prescribing is a Schedule 8 medicine, a further state approval form will appear.

A final summary page will allow you to check the details you have entered. If they are correct, you can submit the application.


Step 3: Application evaluated by TGA and state or territory

Once you have submitted your application it will be evaluated by the TGA as well as the relevant state or territory authorities. As the prescriber, you may be contacted by the TGA or the local authority for more information about the application.


Step 4: Notification

You will receive a single email from the TGA that contains the outcome of both the TGA and the state or territory’s decision. Provided each party has all the necessary information, this decision should come within two business days. You will need to provide a copy of the TGA and local authority approval document to the patient alongside their prescription for the pharmacist to dispense their medication.