Section 15 of TGO 93 outlines key information that must be included on the label to ensure the safe use of the medicinal cannabis product.
All products
Section 15 sets out the information that must be included on the labels of all medicinal cannabis products that are covered by TGO 93. These requirements are designed to provide prescribers and consumers sufficient information to properly identify the goods and know how to use and store them safely. This information also supports efficient recall processes if a recall is necessary.
Labels should clearly differentiate between medicinal cannabis products that are based on plant material, broad spectrum extracts, full spectrum extracts and isolates (of the active ingredient). Different information is required in each case - more information is required for active ingredients that are not present as isolates. These requirements are set out in section 15 of TGO 93.
Isolates
Where the active ingredient has been refined from the plant preparations to a single cannabinoid only minimal information is required. The name of the cannabinoid and its quantity must be stated on the label.
Plant materials
The cannabinoids that are active ingredients in some medicinal cannabis products are present in plant material that has not undergone any refinement. This does not include physical processing such as cutting or grinding.
The labels of these products must include the following additional information to accurately identify the plant material, see 15(2)(a)-(f) of TGO 93:
- the minimum dry weight or minimum fresh weight of plant material (including the word 'minimum')
- the plant species
- the plant part.
Example: "Cannabis sativa flower dry 500 mg minimum, containing tetrahydrocannabinol 30 mg".
Plant preparations
The cannabinoids that are active ingredients in some medicinal cannabis products are present in plant preparations. These are plant materials that have undergone refinement but not those where the outcome is a single cannabinoid. Plant preparations do include broad and full spectrum extracts, oils, decoctions, and suspensions.
The labels of these products must include the following additional information to accurately identify the plant preparation, see 15(2)(g) of TGO 93:
- the weight of the plant preparation and the minimum dry weight or fresh weight of the plant material from which it was prepared, except if the plant preparation is an essential oil
- the plant species
- the plant part
- the preparation type.
Example: "Cannabis sativa leaf extract 5 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing tetrahydrocannabinol 30 mg".
Mixtures/blends
Where the finished medicinal cannabis product is a blend of two plant preparations, each component needs to be identified accurately.
Example 1: an extract prepared from cannabis leaf containing a high concentration of THC, blended with a second extract prepared from cannabis flowers containing a high concentration of CBD. The labels on this product would state:
- Cannabis sativa leaf extract 50 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing tetrahydrocannabinol 30 mg
- Cannabis sativa flower extract 50mg, derived from Cannabis sativa flower dry 600mg minimum, containing cannabidiol 10mg
Example 2: CBD isolate extracted from Cannabis sativa leaves, blended with leaf resin with stated content of THC. The labels on this product would state:
- Cannabidiol 10 mg and Cannabis sativa leaf extract 50 mg, derived from Cannabis sativa leaf dry 500 mg minimum, containing tetrahydrocannabinol 3 mg.