If you have been prescribed medicinal cannabis in Australia, you may receive a TGA approval letter. Many patients are unsure what this letter means and how it relates to their prescription.
This guide explains how to understand your TGA approval letter, what information it contains, and how it supports the legal dispensing of medicinal cannabis through Dispense Direct.
What Is a TGA Approval Letter for Medicinal Cannabis?
In Australia, most medicinal cannabis products are classified as unapproved medicines, meaning they are not listed on the Australian Register of Therapeutic Goods (ARTG).
To prescribe these products legally, doctors must apply through the Therapeutic Goods Administration (TGA) using either:
- the Special Access Scheme (SAS), or
- the Authorised Prescriber (AP) Scheme
A TGA approval letter confirms that your doctor is authorised to prescribe a specific medicinal cannabis product (or product category) for you under Australian law.
Why Do Patients Need TGA Approval for Medicinal Cannabis?
TGA approval is required to ensure:
- patient safety
- appropriate clinical oversight
- legal prescribing and dispensing
- compliance with Australian regulations
This approval does not mean the TGA has endorsed medicinal cannabis as a standard treatment for your condition. It means access has been permitted on an individual patient basis.
Key Sections of a TGA Approval Letter Explained
The approval letter usually includes:
- patient initials or identifier (full names are often excluded for privacy reasons)
- age range
- prescriber details
- approved medicinal cannabis product
The approved product will list:
- product name or category
- THC and/or CBD classification
- dosage form (oil, capsule, flower)
- route of administration (oral, inhaled)
Pharmacies can only dispense medicinal cannabis that matches both the TGA approval and the prescription.
The TGA letter will also include an expiry date of the approval.
After expiry:
- a new approval may be required
- your prescriber will advise on renewal if treatment continues
How Dispense Direct Uses Your TGA Approval
At Dispense Direct, we verify that:
- your prescription matches your TGA approval
- the product supplied is compliant with regulations
- dispensing occurs legally and safely
If clarification is needed, we work directly with your prescriber to avoid delays.
Do Patients Need a Copy of Their TGA Approval Letter?
Not always. In many cases the prescriber or clinic holds the approval and sends it directly to the pharmacy.
If required, Dispense Direct may contact your clinic to confirm approval details.
Need Help Understanding Your Medicinal Cannabis Approval?
Medicinal cannabis regulations in Australia can be complex. If you have questions about:
- your TGA approval
- prescription limitations
- dispensing requirements
Our team at Dispense Direct can explain the process and guide you back to your prescriber when needed. Give us a call at 1300 420 965 or send us an email at hello@dispensedirect.com.au to discuss.