The only cannabis medicines currently registered in Australia under the Australian Register of Therapeutic Goods (ARTG) are Epidyolex® (cannabidiol) and Sativex® (nabiximols). Cannabidiol is included under Schedule 4 (S4) and nabiximols under Schedule 8 (S8) of the Poisons Standard (SUSMP).
An approval* from NSW Ministry of Health is required to prescribe or supply any Schedule 8 medicine to a drug dependent** person. To apply for approval you must submit an Application for authority to prescribe or supply a Schedule 8 cannabis medicine for human therapeutic use.
Most cannabis medicines available in Australia are unregistered or unapproved medicines. Unapproved medicines have not been assessed by the Therapeutic Goods Administration (TGA) for safety, quality, or effectiveness.
To prescribe or supply unapproved Schedule 8 cannabis medicines a prescriber must:
For clinical guidance and prescribing advice see Clinical guidance for cannabis medicine prescribers.
For details on available unapproved medicinal cannabis products refer to the Therapeutics Goods administration (TGA) Medicinal cannabis products by active ingredients. Information about access pathways to medicinal cannabis can be found at the TGA Medicinal cannabis hub.
Products are available from manufacturers and wholesalers licensed by the Office of Drug Control. All cannabis medicines products used in Australia are required to comply with the Standard for Medicinal Cannabis (TGO 93).
In NSW only medical practitioners can prescribe Schedule 8 medicines that are extemporaneously compounded.
Due to the number of unapproved Schedule 8 cannabis medicine products available under the TGA Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway, a cannabis medicine that needs to be extemporaneously prepared should be rarely required. For a list of available medicinal cannabis products under these schemes refer to Medicinal cannabis products by active ingredients.
Schedule 8 cannabis medicines that are extemporaneously compounded for a particular person for therapeutic use for that person, require approval under the:
To apply for SAS or AP approval see the TGA Prescribe an unapproved therapeutic good (health practitioners).
To apply for NSW Ministry of Health approval you must submit an Application for Authority to Prescribe or Supply an Unregistered or (Pharmacy) Extemporaneously-Compounded Schedule 8 Product for Human Therapeutic Use.
For more information see Restrictions on unregistered Schedule 8 medicines including compounded medicines.
A NSW Ministry of Health approval is not required when continuing treatment with a Schedule 8 cannabis medicine for:
For queries on prescribing or supplying cannabis medicines, please contact the Pharmaceutical Services Unit by email at MOH-PharmaceuticalServices@health.nsw.gov.au.
*An approval has the same meaning as an authority under the Poisons and Therapeutic Goods Act 1966.
**A drug dependent person means a person who has acquired an overpowering desire for the continued administration of a drug of addiction (Schedule 8) or a prohibited drug (including but not limited to heroin, methylamphetamine, or cocaine) as a result of repeated administration of that drug. Any person who has been treated under the Opioid Treatment Program (OTP) is a drug dependent person.