Regulations and approvals

Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods.

The TGA makes sure that all therapeutic goods sold in Australia are safe. This includes medications, medical devices and other health-related products. In addition, the TGA controls how those products are manufactured and advertised.

If you would like to know more about the TGA, you can visit their website.

TGA regulations

Medical cannabis falls under the category of "unapproved therapeutic goods" in Australia. This means it has not been evaluated by the TGA and can only be accessed in certain circumstances. Health practitioners can prescribe unapproved therapeutic goods to patients through the Special Access Scheme (SAS) or the Authorised Prescriber (AP) scheme.

Many of our doctors are registered as Authorised Prescribers (AP) which means they have approval to prescribe certain products to you without having to notify the TGA each time. This greatly reduces the waiting time and ensures you receive your medication sooner.     

We actively look to assist our doctors in obtaining AP status to speed up approval times, where appropriate. 

The Special Access Scheme (SAS) requires the doctor to apply to the TGA to prescribe certain products to you on a case-by-case basis. You will then need to wait for the SAS approval before our partners at uMeds can process your first order.

SAS approval

When your Alternaleaf doctor creates your prescription, a SAS application is automatically submitted to the TGA if needed. The TGA handles all SAS approvals, and depending on demand, they can take anywhere from 5 to 7 business days to process. Unfortunately, we cannot expedite this.

You can still place an order through our partner uMeds, but it won't begin processing until we receive the SAS approval. Once approved, your order will process automatically, and no further action is required from you.

This affects only your first order from a prescription, and any future repeat orders will process as normal. Please note that SAS approval requirements may vary with different doctors, so if you've received a prescription before without needing SAS approval, that could change with a new doctor.

Discounts

Our partners at uMeds don’t offer discounts on medication, with the exception of eligible concession card holders. Similar to other prescribed medications, there are limitations in place around when and how discounts can be applied.

This means that neither we nor our partners at uMeds are able to offer discounts on medication as compensation for any issues that may arise. Other forms of compensation may be an option, but this is decided by our internal escalations team on a case-by-case basis.

Vaping devices

Due to recent legislative changes, only TGA-registered devices that are listed on the Australian Register of Therapeutic Goods (ARTG) are available for sale. All other devices, including batteries for vape carts are no longer available and have been removed from the ordering portal.

Currently only the Storz & Bickel Mighty Medic is available to purchase through our partners at uMeds in your patient portal.

Unfortunately, we are unable to give you specific information on where you can buy these devices. We suggest you have a discussion with your pharmacist around how to get the right device for your medication.

Products

Unfortunately, we are unable to provide pricing or information on brands that are not specifically prescribed to you.

Your prescribed products are shown with plain packaging in your patient portal, which is standard for prescription medications. The medications will still arrive with proper labelling and packaging.    

If you would like to know more about alternative medications or formulations, please discuss your options with your Alternaleaf doctor at your next follow-up consultation. They will work with you to create an appropriate treatment plan.

Quality

All medical cannabis products, whether they are manufactured in Australia or imported into Australia, must meet the quality standards that the Therapeutics Goods Administration (TGA) has set. 

Medical cannabis products in Australia must comply with the __[TGO 93](https://www.legislation.gov.au/Details/F2022C01204)__ and __[TGO 100](https://www.legislation.gov.au/Details/F2022C00360)__ standards. These standards specify the minimum quality requirements for medical cannabis and the microbiological standards for medicines.