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Conforming with Therapeutic Goods (Standard for Medicinal Cannabis) (TGO 93) Order 2017
Version 1.2, May 2019
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.
This guidance is for manufacturers and sponsors, to assist in ensuring medicinal cannabis products conform with TGO 93. A Compliance checklist for sponsors is also available which outlines the specific criteria and paperwork required for submission to the TGA.
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.
The TGA has developed a declaration form that must be completed for unapproved medicinal cannabis products to declare that the product(s) conform to TGO 93. This should be completed by the medicinal cannabis product manufacturer.
This form should be completed prior to the supply of any new unapproved medicinal cannabis products in Australia, and also following any material change to medicinal cannabis products (including cannabis plants used in their manufacture) that were the subject of a previous declaration of conformity provided to the TGA where that change could have affected the quality of the products.
The reason for requesting that the medicinal cannabis product manufacturer complete the declaration form is that the person importing or supplying the unapproved medicinal cannabis product(s) in Australia may not be the commercial sponsor of the good (for example, a medical practitioner). The highly technical nature of TGO 93 means that this person may not be in a position to declare that the product conforms to the standard. The manufacturer of the medicinal cannabis product that has responsibility for quality control testing of the finished product is best placed to declare that the medicinal cannabis product conforms to this standard.
The manufacturer of the medicinal cannabis product(s) should submit the completed form to the person applying to access the medicinal cannabis product(s) through the available access pathways.
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.
For unapproved medicinal cannabis products to be accessed via:
- SAS and Authorised Prescriber: The medical practitioner is required to submit this form as supportive documentation to the TGA with their notification or application, unless the sponsor has already submitted the form to the TGA on the applicant's behalf
- Clinical trials - CTN/CTX: The Australian clinical trial sponsor should complete the section at the end of the form to include the name of the medicinal cannabis product(s) used in the clinical trial as well as the TGA clinical trial application number and protocol number. The clinical trial sponsor is then required to submit this form as supportive documentation to the TGA with their application or notification, as applicable. In the case of a CTN involving the use of a medicinal cannabis product, the clinical trial sponsor should submit this form via email to firstname.lastname@example.org. In the case of a CTX involving the use of a medicinal cannabis product, the clinical trial sponsor should submit this form as part of the CTX application made to the TGA.