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Access to medicinal cannabis products: using access schemes
Determine your state/territory regulatory requirements
In most states and territories in Australia, approval or permission is required by a medical practitioner in order to prescribe medicinal cannabis products to their patient(s).
Additionally, particular medicinal cannabis products may be scheduled differently under the Schedule of Medicines and Poisons (SUSMP or 'Poisons Standard'). The adoption of the SUSMP may vary between different states and territories.
The medical practitioner should check for any relevant state/territory approvals to prescribe a particular medicinal cannabis product for the particular patient, noting that these may vary depending on the scheduling and between jurisdictions.
Contact the relevant state or territory medicinal cannabis area in your state or territory health department for further information.
|ACT||02 6205 email@example.com||ACT Health|
|NSW||02 9391 9944 (medical practitioners only)||firstname.lastname@example.org||
General information: Centre for Medicinal Cannabis Research and Innovation
|Northern Territory||08 8999 2633||chiefhealthofficer.DoH@nt.gov.au|
Phone: 07 3708 5283
Fax: 07 3708 5431
|South Australia||1300 652 584 (medical practitioners only)||HealthDrugsofDependenceUnit@sa.gov.au||SA Health|
|Tasmania||03 6166 email@example.com||Department of Health and Human Services|
|Victoria||03 9096 firstname.lastname@example.org||Health.vic|
|Western Australia||08 9222 6883||MPRB@health.wa.gov.au||
Overview: Government of Western Australia
Medicines and Poisons Regulation Branch: Government of Western Australia
Submit an application or notification under the Special Access Scheme or an application under the Authorised Prescriber Scheme
Medical practitioners applying to access medicinal cannabis products for their patients should review Special Access Scheme (SAS) and Authorised Prescriber web pages to assist in the application/notification processes.
As of 30 July 2018 an online system was introduced to enable the lodgement of SAS applications and notifications through an online system. The TGA has been working in collaboration with the State and Territory Health Departments to streamline the application processes pertaining to the prescription of and subsequent access to unapproved medicinal cannabis products in Australia.
The SAS online system will allow prescribers in certain States and Territories to submit an application to both the TGA and the relevant State/Territory Health Department simultaneously. Prior to the introduction of this system, prescribers of unapproved medicinal cannabis products were required to complete and submit papers forms to the TGA and relevant State Health Department separately.
Further information on the SAS online system and details on the submission of medicinal cannabis applications can be found at: Special Access Scheme (SAS).
Medical practitioners notifying the TGA through SAS (Category A) or applying to the TGA to access medicinal cannabis products for their patients under the SAS (Category B) or the Authorised Prescriber Scheme must provide information to satisfy the criteria around the patient, product and prescriber. This is consistent with the principles described in the guidelines Access to unapproved therapeutic goods via the Special Access Scheme and Access to unapproved therapeutic goods: Authorised prescribers, respectively.
Devices to administer certain medicinal cannabis products
For products to be administered via inhalation through a vaporising device, medical practitioners should note that there are currently no vaporising devices included on the ARTG to be used for medicinal cannabis.
A vaporising device can be obtained through the unapproved medical device access pathways, which also include the Authorised Prescriber Scheme, SAS and the Personal Importation Scheme.
It should be noted that if a medicinal cannabis product for inhalation is approved or authorised under the SAS Category B or the Authorised Prescriber Scheme, this approval would be conditional on use with an appropriate medical device.
Apply for a licence and permission to import, if necessary
Cannabis, cannabis resin, extracts, oils and tinctures of cannabis, and cannabinoids (including cannabidiol and tetrahydrocannabinols) are captured under the Customs (Prohibited Imports) Regulations 1956. A licence and permission to import is required prior to importing any product containing these substances.
The Office of Drug Control (ODC) hosts a list of manufacturers and suppliers of medicinal cannabis products on its website. Some suppliers may have stock available in Australia removing the need for the medical practitioner, or pharmacist acting on behalf of the medical practitioner to arrange for import. Please see the ODC website for more information.
If a medicinal cannabis product has not already been imported by the sponsor, a medical practitioner, or pharmacist acting on behalf of the medical practitioner, can apply for a licence and permission to import.
Licence and permit application forms and guidance are available on the ODC website.