How to apply to prescribe or supply Schedule 8 and unregistered 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

Applying to prescribe or supply 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 (by medical practitioners 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 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.

Applying to the TGA

The TGA has an online system to apply for authorisation to prescribe or supply unregistered cannabis medicines under the Special Access Scheme (SAS). This online system is available on the TGA.

Prescribers 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:

1. 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.]
2. prescribing or supplying for a clinical trial (if it is an unregistered cannabis medicine), or
3. 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 a medical practitioner by application to NSW Health.]

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.

A medical practitioner must submit an application directly to NSW Health:

• to prescribe or supply 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 or supply a registered cannabis medicine for a drug dependent patient or a patient under 16 years of age.

The form Application for Authority to Prescribe or Supply a Schedule 8 Cannabis Medicine for Human Therapeutic Use is to be used in these circumstances.

A NSW Authority is not required 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 or nurse 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 or Supply a Substance for the Purpose of Human Research is to be used.

Information about clinical trials is available on National Health and Medical Research Council - Australian clinical trials.

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.

Pathways for prescribing or supplying Schedule 8 cannabis medicines

Pathways for registered and unregistered Schedule 8 cannabis medicines under the Special Access Scheme (SAS)

Alternative text: Pathways for registered and unregistered Schedule 8 cannabis medicines under the Special Access Scheme.

Authorised Prescriber and Clinical Trial pathways for Schedule 8 cannabis medicines

Alternative text: Authorised Prescriber and Clinical Trial pathways for Schedule 8 cannabis medicines.

More information

For more information, visit prescribing compounded medicines.

Resources

Fact sheet for medical practitioners - Legal access to cannabis based medicines.