Unapproved medicinal cannabis products imported into and supplied/manufactured in Australia must conform with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 (TGO 93). TGO 93 is a standard that specifies minimum quality requirements for medicinal cannabis products.
The Guidance on quality requirements for medicinal cannabis products, Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 - including 2022 Amendments, is for manufacturers and sponsors, to assist in ensuring medicinal cannabis products conform with TGO 93.
Responsibility for products conforming with TGO 93 rests with the sponsor. It is an offence under the Therapeutic Goods Act 1989, to import, export, or supply therapeutic goods that do not conform to an applicable standard.
Please note that although the cannabis plant used in the manufacture of the medicinal cannabis product must meet the requirements of Schedule 1 of TGO 93, reduced or rotational testing of the cannabis plant used in the manufacture of the product can be carried out provided that this is justified on good manufacturing practice (GMP) grounds. For example, a manufacturer may be able to justify reducing or not conducting pesticide testing if no pesticides are used in the cultivation of the cannabis plant. Medicinal cannabis products, like any therapeutic good may be subject to testing by the TGA at any time to ensure compliance with relevant standards.
CORRECTION TO THEREAPUTIC GOODS (STANDARD FOR MEDICINAL CANNABIS) (TGO 93) Order 2017, Schedule 1
It has come to the attention of the TGA that the ‘Table of specified tests’ in Schedule 1(2) of the current version of Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017 contains a transposition error.
In Item 3, the Test Method listed in Column 3 (Ph Eur 2.4.8) is incorrect. The method should read: Ph 2.4.27.
The corrected row of the table reads as follows:
| Column 1 Item | Column 2 Parameter Column | Column 3 Test Method | Column 4 Limits |
|---|---|---|---|
| 3 | Heavy Metals | Ph 2.4.27 | Not more than 3.0 mg/kg of arsenic Not more than 0.5 mg/kg of cadmium Not more than 5.0 mg/kg of lead Not more than 0.5 mg/kg of mercury |
We will amend TGO 93 to correct this error as soon as possible. In the meantime, you should follow the correct test method Ph 2.4.27.