Under TGA laws, there are four approved pathways for doctors to access unapproved medical cannabis products, provided it is clinically suitable for their patients.

1. Authorised Prescriber - Established History of Use pathway
2. Authorised Prescriber - Standard pathway
3. SAS Category A notification pathway
4. SAS Category B application pathway

This session is tailored to assist doctors and nurse practitioners in navigating the Special Access Scheme B (SAS-B) application pathway.

This session offers doctors and nurse practitioners the opportunity to book a 1-1 online discussion with a SAGED prescriber support specialist to assist them in navigating the SAS-B application pathway.

The session is 45 minutes long and delivered in an online video meeting format.

Guided by our prescriber support specialist, you will receive step-by-step assistance in applying for SAS-B approvals, equipping you to prescribe medical cannabis to patients with qualifying needs.

Upon completion of your online session, you will be able to:

1. Describe the available pathways for prescribing medical cannabis, tailored to your clinical role and your patient's needs
2. Set up and log into your account on the TGA’s SAS and AP Online System
3. Submit application/s for SAS-B approvals with the TGA
4. Prescribe medical cannabis in accordance with regulatory requirements for this pathway.*

*TGA approval is required for each application, and outcomes are not guaranteed. In Australia, all medical cannabis prescriptions must be supported by the prescriber’s TGA approval letter, which authorises the specified product to be ordered and dispensed by the relevant pharmacy.

Where certain conditions are met, eligible practitioners can apply to prescribe unapproved goods via 1 of 2 schemes. 

• Via the Special Access Scheme (SAS) practitioners can apply to access an unapproved product for individual patients on a case-by-case basis.¹
• Via the Authorised Prescriber scheme, practitioners can apply to access an unapproved product for multiple patients with the same condition²

SAS grants prescribers access to medical cannabis for 1 approved patient. But within the SAS, there are 3 separate pathways to choose from, each with different requirements and processes.

The SAS-B pathway allows eligible medical practitioners—or registered healthcare practitioners acting on their behalf—to apply for TGA approval to prescribe unapproved therapeutic goods, such as medical cannabis, for individual patients who do not meet the criteria for SAS-A or SAS-C.

Applications are assessed on a case-by-case basis and must include clinical justification for use. Practitioners must apply and receive an approval letter from the TGA before prescribing or supplying the product. The approval process typically takes 2 to 5 business days.

Practitioners must ensure the proposed treatment aligns with their scope of practice, qualifications, and relevant state or territory regulations. If the applicant lacks experience managing the patient's specific condition, a letter of support from an appropriate specialist must accompany the application.

Reference List:

1. Unapproved products for individual patients (Special Access Scheme)
2. Unapproved products for multiple patients (Authorised Prescriber)

• SAGED online sessions do NOT offer medical prescribing advice to healthcare practitioners.
• SAGED will NOT complete applications on behalf of any healthcare practitioners.
• The Special Access Scheme B (SAS-B) - Online Application Support session is designed to support practitioners throughout their SAS-B application process. 
• SAGED does NOT take responsibility for the prescribing habits or practices of any healthcare practitioners.
• SAGED does NOT take responsibility for the outcome/decision of the TGA in certifying SAS-B applications.

Before applying to access an unapproved product, all prescribers should:

• consider approved products 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 product is available in a format and dosage that is appropriate and accepted by the patient

For any questions, please contact hello@saged.com.au.

Book a session using the form above, and choose your preferred date and time.

Once booked, you will receive confirmation of your session via email which includes a link to join your session's video meeting.

You will receive two reminder emails 24 hours and 30 minutes before your session. Please check your junk/spam folder if you are unable to locate this email, or email hello@saged.com.au for support.

Log in or register on the TGA Special Access Portal

To ensure you get the most out of your 1-hour session with SAGED, please log in or register on the TGA Special Access Portal before your session.

Log in or register on the TGA Special Access Portal at this link:https://compliance.health.gov.au/sas/

Review TGA resources

We recommend reviewing the following resources prior to your session.

• TGA Medical Cannabis FAQs
• TGA Authorised Prescribers
• TGA Special Access Scheme
• TGA Applications and Reporting

Once you've completed your pre-session tasks, all that's left to do is to attend your session at the time and date booked in.

To make any changes to your session booking, please refer to your booking confirmation email or contact hello@saged.com.au.