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New streamlined process for medicinal cannabis applications

The Therapeutic Goods Administration (TGA) is making some important changes to the access framework and application processes for ‘unapproved’ medicinal cannabis products from 22 November 2021. The changes reduce administrative burden for prescribers and industry and further improve patient access to medicinal cannabis.


Medicinal cannabis product sponsors will no longer need to submit a declaration of compliance with the quality standard (Therapeutic Goods Order, TGO 93) to the TGA. However the TGA regularly conducts random and targeted monitoring and laboratory testing of medicinal cannabis products to check for compliance.


Sponsors continue to be legally responsible for ensuring that their products comply with TGO 93, and all other relevant orders as breaches are subject to compliance actions, including civil and criminal penalties. Sponsors are still legally required to submit six monthly reports on unapproved product usage, and to simplify this requirement a sponsor six monthly report form is now available.


The TGA will also now accept SAS and Authorised Prescriber submissions for medicinal cannabis products by active ingredient, rather than by trade name. Products will be categorised by cannabinoid content as follows:

  • Category 1 CBD medicinal cannabis product (CBD ≥98%)

  • Category 2 CBD dominant medicinal cannabis product (CBD ≥60% and <98%)

  • Category 3 Balanced medicinal cannabis product (CBD <60% and ≥40%)

  • Category 4 THC dominant medicinal cannabis product (THC 60-98%)

  • Category 5 THC medicinal cannabis product (THC >98%)

Lower risk category 1, 2 and 3 medicinal cannabis medicines have been included in the Authorised Prescriber ‘Established history of use’ pathway, by reference to active ingredient categories, dosage forms and indications. For these medicines, approval from a Human Research Ethics Committee or medical specialist college endorsement will no longer be required before applying to the TGA to become an Authorised Prescriber. Authorised Prescribers can prescribe the unapproved medicine to patients under their direct care without the need for separate approvals for individual patients.


As for any other prescription, the prescriber can either write the ‘generic’ medicine name or include the product’s trade name if it is clinically necessary. Pharmacist decisions regarding substituting brands, or whether a new prescription is required, should be made in accordance with normal dispensing practice.


To support health care professionals in prescribing and supplying medicinal cannabis products we will soon publish a list of available medicinal cannabis products and sponsor details under each of these categories.


The TGA is hosting webinars for health care professionals on 22 and 23 November and a webinar for industry on 22 November to provide further details on the changes.


For further information, visit the Medicinal cannabis hub.

Originally published here: https://www.tga.gov.au/media-release/new-streamlined-process-medicinal-cannabis-applications

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