Medicinal Cannabis: Category Determination
To identify the appropriate category please input the CBD and THC concentration desired below:
Concentration CBD: 300
Concentration THC: 20
Resulting category: Category 2
Categories: Range:
Category 1 CBD ≥ 98
Category 260 ≤ CBD < 98
Category 340 ≤ CBD < 60
Category 4 2 ≤ CBD < 40
Category 5 CBD < 2
tegory Determination
ut the CBD and THC concentration desired below:
Overall CBD Percentage: 93.75 %
Overall THC Percentage: 6.25 %
Category 2
Definition:
CBD medicinal cannabis product (CBD ≥98%)
CBD dominant medicinal cannabis product (CBD ≥60% and <98%)
Balanced medicinal cannabis product (CBD <60% and ≥40%)
THC dominant medicinal cannabis product (THC 60-98%)
THC medicinal cannabis product (THC >98%)
Medicinal Cannabis Cate
The following categories are defined and categorised by the TGA
From 22 November 2021, SAS and Authorised Prescriber submissions for unapproved medicinal cannabis products are
rather than by brand (trade) name. Please see below for a detailed summary of the relevant categories:
For additional information please access: https://www.tga.gov.au/medicinal-cannabis-information-health-professionals
SCHEDULE 4: Category 1 - CBD medicinal cannabis product (CBD ≥98%)
CBD content is 98% or greater
A medicinal cannabis product is category 1 when all of the following apply:
- Schedule 4 Prescription Only medicines as per the Poisons Standard; and
- cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and
- any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in c
of the medicine
- the medicine contains no other active ingredients.
SCHEDULE 8: Category 2 - CBD dominant medicinal cannabis product (CBD ≥60% and <
CBD content is at least 60% but less than 98%
A medicinal cannabis product is category 2 when all of the following apply:
- Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total ca
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the re
- the medicine contains no other active ingredients.
SCHEDULE 8: Category 3 - Balanced medicinal cannabis product (CBD <60% and ≥40%)
CBD content is at least 40% but less than 60%
A medicinal cannabis product is category 2 when all of the following apply:
- Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total ca
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the re
- the medicine contains no other active ingredients.
SCHEDULE 8: Category 4 - THC dominant medicinal cannabis product (THC 60-98%)
CBD content is at least 2% but less than 40%
A medicinal cannabis product is category 2 when all of the following apply:
- Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total ca
- other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the re
- the medicine contains no other active ingredients.
SCHEDULE 8: Category 5 - THC medicinal cannabis product (THC >98%)
CBD content is less than 2%
A medicinal cannabis product is category 2 when all of the following apply:
- Schedule 8 Controlled Drugs as per the Poisons Standard; and
- cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cann
content of the medicine; and
- cannabidiol comprises less than 2% less of the total cannabinoid content of the medicine
- the medicine contains no other active ingredients.
abis Categorisation:
egorised by the TGA in relation to medicinal cannabis.
nal cannabis products are made by active ingredient under a category based on cannabinoid content,
ategories:
ion-health-professionals
8%)
y:
nd
the medicine; and
e naturally found in cannabis and comprise 2% or less of the total cannabinoid content
t (CBD ≥60% and <98%)
y:
n 98% of the total cannabinoid content of the medicine; and
abis comprise the remaining cannabinoid content of the medicine
D <60% and ≥40%)
y:
n 60% of the total cannabinoid content of the medicine; and
abis comprise the remaining cannabinoid content of the medicine
t (THC 60-98%)
y:
n 98% of the total cannabinoid content of the medicine; and
abis comprise the remaining cannabinoid content of the medicine
8%)
y:
turally found in cannabis and comprise more than 98% of the total cannabinoid
t of the medicine
