Access and approvals for cannabis medicines

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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.

Unregistered cannabis medicines

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:

  1. Practice within their scope of practice and be competent to assess evidence to use unapproved medicines.
  2. Consider all clinically appropriate treatment options that are registered medicines under the Australian Register of Therapeutic Goods (ARTG) before applying to access unapproved cannabis medicines.
  3. Obtain informed consent from the patient or patient’s carer for the use of an unregistered product. See also   Prescribing cannabis medicines to adult patients who lack capacity to consent. 
  4. Accept responsibility for any adverse consequences of treatment.
  5. Establish whether the patient is being prescribed or supplied any other Schedule 8 medicine by other prescribers, and if so, manage as clinically appropriate. SafeScript NSW ​​can be accessed by prescribers for real-time information on a patient’s prescription and dispensing  history for certain high-risk medicines.
  6. Ensure required approvals, as described below, are obtained to prescribe or supply the unregistered cannabis medicine.
  7. Ensure the purpose and dosage of the medicine prescribed or supplied is in accordance with therapeutic standards.
  8. ​Ensure the quantity of the cannabis medicine prescribed or supplied is in accordance with the dose and directions prescribed.
  9. Practice under their profession’s code of conduct and provide treatment options that are based on the best available information and are not influenced by financial gain or incentives.

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)​​​​​.

Approval requirements for unregistered Schedule 8 cannabis medicines

To prescribe or supply an unregistered Schedule 8 cannabis medicine an approval from the TGA is required via the Special Access Scheme (SAS) or Authorised Prescriber (AP) pathway. To apply for approval see Prescribe an unapproved therapeutic good (health practitioners)​​​. 
 
In NSW, additional approval is required when prescribing or supplying any unregistered Schedule 8 cannabis medicine that is: 
  • for a drug dependent person, or
  • extemporaneously compounded, or 
  • unregistered and for a clinical trial
Applications to prescribe and supply in these situations can be found at Application forms for approval to prescribe or supply. 
 

E​xtemporaneously compounded Schedule 8 cannabis medicines

​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:

  1. TGA SAS​​​​​​​​ or AP​​​ pathway, and 
  2. NSW Ministry of Health.

​​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.

Exceptions from NSW Ministry of Health approvals

A NSW Ministry of Health approval is not required when continuing treatment with a Schedule 8 cannabis medicine for:

  • an inpatient in hospital, if the patient was issued a valid approval before the hospital admission
  • a patient in the community, if the patient has valid approval from a prescriber practicing at the same premises as the prescriber wishing to prescribe or supply this medicine.

More information

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.

Current as at: Thursday 20 June 2024
Contact page owner: Pharmaceutical Services