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How To Apply To Prescribe or Supply Schedule 8 and Unregistered Cannabis Medicines Cannabis Medicines
How To Apply To Prescribe or Supply Schedule 8 and Unregistered Cannabis Medicines Cannabis Medicines
How To Apply To Prescribe or Supply Schedule 8 and Unregistered Cannabis Medicines Cannabis Medicines
On this page
1. Applying to prescribe or supply Schedule 8 cannabis medicines
2. Applying to the TGA
3. Applying to NSW Health
4. Pathways for prescribing or supplying Schedule 8 cannabis medicines
obtain informed consent from the patient, or carer, for the use of a product that has not been
assessed for quality, safety and efficacy, if the product is unregistered or the use is not an
approved indication
establish whether the patient is being prescribed or supplied any other Schedule 8 medicine by
other prescribers, and if so, manage as clinically appropriate. The prescriber must determine if
the patient is drug dependent involving either dependence to Schedule 8 medicines or other
prohibited drugs (including but not limited to heroin, methylamphetamine or cocaine) and make
application to NSW Health.
Prescribers are encouraged to use the TGA’s online system for SAS applications.
The Poisons and Therapeutic Goods Act 1966 sets the controls on the prescribing and supply of
Schedule 8 cannabis medicines in NSW. To prescribe or supply a Schedule 8 cannabis medicine, an
application to NSW Health is required in certain circumstances. These are where:
Prescribers are encouraged to use the TGA’s online system for SAS applications to NSW to prescribe
or supply unregistered Schedule 8 cannabis medicines as this provides a streamlined application
pathway. This online system is available on the TGA’s website [https://www.tga.gov.au/special-
access-scheme-and-authorised-prescriber-online-system] .
The form Application for Authority to Prescribe or Supply a Schedule 8 Cannabis Medicine for
Human Therapeutic Use [https://www.health.nsw.gov.au/pharmaceutical/Documents/cannabis-
appln.pdf] is to be used in these circumstances.
to continue treatment with a Schedule 8 cannabis medicine for a patient in hospital, if the patient
was subject of an authority immediately prior to hospital admission
to continue treatment with a Schedule 8 cannabis medicine for a patient in community, if the
patient is subject of an authority, and the medical or nurse practitioner is practising at the same
https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/how-to-apply.aspx 2/4
premises that the holder of the authority was practising at when the authority was issued.
6/20/23, 12:22 AM How to apply to prescribe or supply Schedule 8 and unregistered cannabis medicines - Cannabis medicines
A NSW Authority to prescribe or supply an unregistered cannabis medicine for the purpose of a
clinical trial is required in all circumstances.
To apply for a NSW Authority to prescribe or supply an unregistered Schedule 8 cannabis medicine
for the purpose of a clinical trial, the form Application for Authority to Prescribe or Supply a
Substance for the Purpose of Human Research
[https://www.health.nsw.gov.au/pharmaceutical/Documents/human-research.pdf] is to be used.
Information about clinical trials is available on National Health and Medical Research Council -
Australian clinical trials [https://www.australianclinicaltrials.gov.au/] .
[https://www.health.nsw.gov.au/pharmaceutical/Documents/pathway-reg-sas-s8cannabis.pdf]
Alternative text: Pathways for registered and unregistered Schedule 8 cannabis medicines under
the Special Access Scheme
[https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/pathway-reg-sas-
https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/how-to-apply.aspx 3/4
s8cannabis-alt.aspx] .
6/20/23, 12:22 AM How to apply to prescribe or supply Schedule 8 and unregistered cannabis medicines - Cannabis medicines
[https://www.health.nsw.gov.au/pharmaceutical/Documents/pathway-ap-trial-s8cannabis.pdf]
Alternative text: Authorised Prescriber and Clinical Trial pathways for Schedule 8 cannabis
medicines [https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/pathway-ap-
trial-s8cannabis-alt.aspx] .
More information
Resources
Fact sheet for medical practitioners - Legal access to cannabis based medicines
[https://www.health.nsw.gov.au/pharmaceutical/Factsheets/cannabis.pdf] .
Related Links
Approvals for authority to prescribe or supply Schedule 8 cannabis medicines
[https://www.health.nsw.gov.au/pharmaceutical/Pages/authority-cannabis.aspx]
https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/how-to-apply.aspx 4/4