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 in navigating the Authorised Prescriber - Established History of Use pathway.

SAGED offers doctors the opportunity to book a 1-1 online session with a prescriber support specialist to assist them in navigating the Authorised Prescriber–Established History of Use pathway.

The session is 1 hour long and delivered in an online video meeting format.

Guided by our prescriber support specialist, you’ll receive step-by-step assistance in applying for a minimum of four (4) Authorised Prescriber (AP) approvals, equipping you to prescribe medical cannabis to patients with qualifying needs.

You will have the option to apply for AP approvals for specific, clinically-supported conditions, including:

• Refractory chronic pain in adult patients
• Refractory anxiety in adult patients
• Refractory sleep disorders in adult patients
• Refractory cancer pain in adult patients
• Refractory autism spectrum disorder in adult patients

Upon completion of your online session, you will:

• Successfully submit applications for a minimum of four (up to ten) Authorised Prescriber (AP) approvals with the TGA
• Receive the outcome of your TGA applications within approximately 10 business days after submission*
• Be able to prescribe medical cannabis^

*Approval is subject to TGA decision, and successful applications are not guaranteed.

^Within Australia, every medical cannabis prescription must be accompanied by the prescriber’s TGA outcome letter which enables the specific medical cannabis product to be ordered and dispensed by the relevant pharmacy.

The Established History of Use pathway allows doctors to prescribe categories of medical cannabis products that contain lower proportions of THC, under controlled dosage forms and for adult patients with specific & tried medical conditions.

This pathway limits the prescription of medical cannabis to products within Categories 1, 2, & 3, which have been categorised based on the proportion of cannabidiol (CBD) relative to the total cannabinoid content.

Permitted categories under the Established History of Use pathway:

• Category 1: CBD medicinal cannabis product (CBD ≥ 98%)
• Category 2: CBD dominant medicinal cannabis product (CBD ≥ 60% and < 98%)
• Category 3: Balanced medicinal cannabis product (CBD <60% and ≥ 40%)

Note: Categories 4 and 5 (THC dominant products with THC 60-98% and THC >98%) are not available under this pathway.

Eligible conditions for prescription under this pathway include:

• Refractory chronic pain in adult patients
• Refractory anxiety in adult patients
• Refractory sleep disorders in adult patients
• Refractory cancer pain in adult patients
• Refractory autism spectrum disorder in adult patients

Permitted dosage forms:

• Oral liquids/oils
• Capsules

• SAGED online sessions do NOT offer medical prescribing advice to healthcare practitioners.
• SAGED will NOT complete applications on behalf of any healthcare practitioners.
• The Authorised Prescriber - Online Application Support session is designed to support practitioners throughout their TGA Authorised Prescriber 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 Authorised Prescribers.

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 and affordable for the patient

For any questions, please contact hello@saged.com.au(opens in a new tab).

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 and consider your preferred AP approvals before your session

Under the TGA’s Established History of Use - Authorised Prescriber scheme, prescribers can choose from the following indications, categories and dosage forms for their prescriptions.

Each AP approval requires a selection from each of the following:

Step 1: Select from 5 clinical indications available to prescribe.

• Refractory chronic pain in adult patients
• Refractory anxiety in adult patients
• Refractory sleep disorders in adult patients
• Treatment of autism spectrum disorder in adult patients
• Refractory cancer pain in adult patients

Step 2: Select from medical cannabis categories available.

• Category 1 CBD medicinal cannabis product (CBD ≥98%)
• Category 2 CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
• Category 3 Balanced medicinal cannabis product (CBD <60% and ≥40%)

Step 3: Select the dosage form suited to your patients.

• Oil (oral liquid)
• Capsule

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.