As with any prescribing, the legal obligations and the responsibility for the treatment of the patient lies with the prescribing practitioner. Most cannabis medicines are not registered on the Australian Register of Therapeutic Goods (ARTG), which means they have not been evaluated to ensure they meet strict standards of safety, quality and effectiveness. For this reason, it is expected that prescribers will have considered all clinically appropriate treatment options that are included in the ARTG before applying to access an unregistered cannabis medicine.
For further information please visit the TGA Medicinal cannabis hub. NSW Ministry of Health guidance can be found at Clinical guidance for cannabis medicine prescribers and Access and approvals for cannabis medicines.
A NSW approval is required when prescribing or supplying a Schedule 8 medicine:
An approval from NSW Health is not needed to prescribe a Schedule 4 cannabis medicine.
More information is available at Access and approvals for cannabis medicines and Application forms for approval to prescribe or supply.
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No accreditation is required to dispense cannabis medicines. Any registered pharmacist in NSW can dispense a cannabis medicine that is unregistered (non-ARTG). For more information see Prescriptions, dispensing, storage and record keeping of cannabis medicines and the TGA Medicinal cannabis hub
If the cannabis medicine is not available in Australia, the prescriber will need to inform you of the importation arrangements.
All compounded Schedule 8 cannabis medicines require the prescriber to hold prior written approval issued by the NSW Ministry of Health. The approval number must be included on the prescription. It is illegal to prescribe or dispense compounded cannabis medicines without such approval.
except those cannabidiol-only products as defined in Schedule 4 of the Poisons Standard.
All cannabis products not classified as Schedule 8 or Schedule 4 default to their classification as prohibited drugs under the Drug Misuse and Trafficking Act 1985, whose possession is illegal, unless authorised for the purpose of scientific research, instruction, analysis or study.
There are legal provisions allowing possession and supply of the following non-therapeutic products:
And if approved for supply under the FSANZ Food Standards Code:
You can, only if the raw material ingredient is included in the Poisons Standard (SUSMP) and:
has been imported, or cultivated and produced, with the approval of the Commonwealth Office of Drug Control and/or Therapeutic Goods Administration, in accordance with the Commonwealth’s Narcotic Drugs Act 1967, and/orTherapeutic Goods Act 1989, and
if it accords with the Medicinal Cannabis Standard (TGO 93), and is included in Schedule 8 of the Poisons List.
No, the prescription is valid for dispensing only as prescribed, including the exact strength/s of active ingredient/s prescribed, and the brand-named product if specified by the prescriber. Substitution of products is not allowed.
Dispensing a different medicine would require a new prescription for that medicine.
No, not until you receive the actual prescription unless it is a registered medicine on the ARTG. Currently, the only ARTG Schedule 8 cannabis medicine is Sativex® brand nabiximols oromucosal spray 80mg/mL for treatment of spasticity due to multiple sclerosis.
You can when the following conditions are met:
There is no provision in NSW legislation for recognising interstate issued authorities or approvals to prescribe Schedule 8 cannabis medicines.
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Yes, if the following conditions are met:
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Yes, if the prescription is valid for dispensing in NSW . See Can I dispense a Schedule 4 cannabidiol medicine on a prescription from a medical practitioner practising in another State or Territory? and Can I dispense an unregistered Schedule 8 cannabis medicine on a prescription from a prescriber practising in another State or Territory?
Where the patient has a paper prescription for a Schedule 8 inform the patient before dispensing that you will need to retain the prescription (including any repeats), as patients from interstate may not be familiar with this NSW requirement. For an electronic prescription with a repeat, you will need to issue a token for the repeat and the next dispensing pharmacist will need to determine if the prescription is valid for dispensing in that State or Territory.
It should not be assumed that an unregistered Schedule 8 medicine lawfully prescribed and dispensed in NSW can be sent to or transit through another State or Territory. Before dispensing the medicine, confirm from the medicines regulator in the other jurisdictions that it is legal for a carrier to possess the medicine in that State or Territory, and legal for the patient to possess and use the medicine in that State or Territory.
Requirements for cannabis medicines are the same or similar to those for other Schedule 8 medicines and for other unregistered medicines. Unregistered medicines have not been assessed by the Therapeutic Goods Administration (TGA) for safety, quality, or effectiveness.
In addition, unless it is lawfully prescribed as a medicine, cannabis is a prohibited drug under NSW law, and classified as a narcotic drug, as well as a prohibited import, under Commonwealth law.
The arrangements in place for access to cannabis medicines are only for human therapeutic use. Cannabis for any other use is prohibited under the NSW Drug Misuse and Trafficking Act 1985. Cannabis medicines may only be used in animals in the context of scientific research or analysis. A NSW Ministry of Health approval is required.
Cannabis medicines are only for the purpose of human therapeutic use and when approved to be prescribed by a registered medical or nurse practitioner. Possession, supply, manufacture, production and cultivation of cannabis for any other purpose, including for recreational use, remain prohibited under the NSW Drug Misuse and Trafficking Act 1985.
Refer to the Therapeutic Goods Administration (TGA) published Advertising guidance for businesses involved with medicinal cannabis products for information on how to comply with therapeutic goods advertising restrictions.
NSW law does not apply in other states and territories. The medicines regulator of the state or territory you are travelling to can provide this information. See the TGA's website for details.
You will need to check the requirements of the country you are travelling to. In some countries import, export or possession of any cannabis product, even if obtained legally for medical use in Australia, may be subject to heavy penalties including imprisonment. Further advice can be obtained on the TGA's website.
Some cruise ship companies may prohibit the possession of cannabis medicines. You will need to contact the relevant company for further advice.
The Commonwealth's Customs laws also limit the type and quantity of medicines with which a traveller may leave and re-enter Australia.
Possession of cannabis which has not been obtained legally under NSW law is an offence, however enforcing compliance with this is at the discretion of police. A small quantity of a cannabis medicine prescribed and dispensed legally for you in another state or territory (that is, with approval/authority from the TGA and the state or territory regulator if necessary) would likely be allowed. We recommend you carry a prescription or letter from your doctor describing the cannabis medicine you are taking and how much you are bringing with you. Keep the medicine in the packaging and labelling as dispensed by the pharmacist.
*An approval has the same meaning as an authority under the Poisons and Therapeutic Goods Act 1966.
