Applying to prescribe Schedule 8 cannabis medicines
To prescribe or supply a Schedule 8 cannabis medicine in NSW, the prescriber must:
- be a registered practitioner who may lawfully prescribe the medicine
- be approved by the Australian Government to import and/or supply that particular product, if it is unregistered, under the Commonwealth’s:
- Special Access Scheme Category (for a particular patient)
- Authorised Prescriber scheme (for a particular group of patients)
- Clinical Trial schemes (for a particular group of patients)
- 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 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.
Applying to the TGA
The TGA has an online system to apply for authorisation to prescribe unregistered cannabis medicines under the Special Access Scheme (SAS). This online system is available on the TGA’s website.
Medical practitioners are encouraged to use the TGA’s online system for SAS applications.
Applying to NSW Health
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:
- prescribing or supplying is for a drug dependent person, or
[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 is a drug dependent person.]
- prescribing or supplying for a clinical trial (if it is an unregistered cannabis medicine), or
- prescribing or supplying is for a child aged under 16 years
[Treatment involving the administration of a Schedule 8 cannabis medicine to a child aged under 16 years requires an exemption under the Children and Young Persons (Care and Protection) Act 1998. This exemption is sought by application to NSW Health.]
Medical practitioners 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.
A medical practitioner must submit an application directly to NSW Health:
- to prescribe an unregistered cannabis medicine for a drug dependent patient or a patient under 16 years of age if they are an Authorised Prescriber
- to prescribe a registered cannabis medicine for a drug dependent patient or a patient under 16 years of age.
The form Application for Authority to Prescribe and Supply a Schedule 8 Cannabis Medicine for Human Therapeutic Use is to be used in these circumstances.
A medical practitioner does not need a NSW Authority in the following 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 practitioner is practising at the same premises that the holder of the authority was practising at when the authority was issued.
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 and Supply a Substance for the Purpose of Human Research
is to be used.
Information about clinical trials is available on the National Health and Medical Research Council’s Australian clinical trials website
For further information on prescribing or supplying cannabis medicines, please contact Pharmaceutical Regulatory Unit by email at MOH-PharmaceuticalServices@health.nsw.gov.au
or on (02) 9391 9944.
Information about prescribing or supplying extemporaneously compounded Schedule 8 medicines or unregistered Schedule 8 medicines other than cannabis medicines is available.
Fact sheet for medical practitioners - Legal access to cannabis based medicines.