In February 2017, the Australian government relaxed regulations relating to the import and warehousing of Medicinal Cannabis, allowing suppliers to bring product into the country for warehousing, prescription and dispensing to pharmacies.
These products don’t have AustL/AustR numbers – they are are all ‘unregistered products’, meaning that they have not gone through detailed clinical trials, So how do doctors know that the products they are prescribing are of suitable quality?
The answer is a new regulation from the TGA – Therapeutic Goods Order No. 93 (TGO 93), the Standard for Medicinal Cannabis.
The main focus of TGO93 is to measure and characterise the contents of the active ingredients in the medicinal cannabis product. For most products the active ingredient is one or more of the various cannabinoid molecules. Cannabinoids need to be measured if they have a concentration of greater than or equal to 2.0% w/w or w/v of the product, or in the case of the unknown psychoactive cannabinoid THC, any concentration greater than 1% must be characterized.
TGO93 also specifies a range of tests of other more harmful compounds that a medicinal cannabis product must meet. These tests include analysis of aflatoxins, foreign matter, heavy metals (arsenic, cadmium, lead and mercury), ochratoxin A, pesticides and total ash.
Currently, manufacturers and importers are only required to declare in writing that their products meet TGO93 although CannabisAccess understands that random testing will be carried out in future by State and Federal agencies, and failure to meet the standard will result in a product recall and other consequences for suppliers.
Products listed on CannabisAccess.com are clearly documented as either having TGO93 certificate, or not (some pipeline products listed are in the process of being TGO93 certified). Healthcare professionals should be aware that products without a TGO93 declaration will not be approved for prescription by TGA or State health departments.
If you are a Healthcare professional, please log onto the CannabisAccess portal for more information.