NSW Cannabis Medicines Advisory ServiceRequirements on the prescriber Requirements on the product | Writing a prescription | Dispensing | Manufacture | Import | Wholesale supply | Storage | Patients | General | Contact details for further information

Applying for authority to prescribe Schedule 8 cannabis medicines

At present in Australia there is only one cannabis medicine registered with the Therapeutic Goods Administration (TGA) - nabiximols oromucosal spray (Sativex®).

While it is generally illegal to supply medicines that not are registered with the TGA, certain unregistered cannabis medicines can be prescribed and supplied if the prescriber and products meet certain requirements.

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.

Alternatively, medical practitioners can use SAS application forms (in PDF and Word format) that are also available on the TGA's website.

In this process, NSW Health relies on a single clinical assessment by the TGA and confines its review to checking the credentials of the prescribing doctor and the patient history, as with any other Schedule 8 drug authority.

Applying to NSW Health

In the following circumstances, a medical practitioner must submit an application directly to NSW Health:

  • prescribe a registered cannabis medicine
  • prescribe under the Authorised Prescriber Scheme
  • prescribe for a clinical trial

The form Application for Authority to Prescribe and Supply a Cannabis Product for Human Therapeutic Use is to be used in these circumstances.

When considering applications, NSW Health records are checked to determine if the prescriber’s authorities for prescribing scheduled medicines have been withdrawn by the Secretary under the Poisons and Therapeutic Goods legislation. Consideration will be given to any conditions placed on the prescriber’s registration as a medical practitioner (as may be published on the Australian Health Practitioner Regulation Agency’s Register of Practitioners).

Prescribers with a history of diversion of controlled substances or poor practice in managing patient/s’ diversion of such substances are unlikely to be granted an authority.

Where the patient is aged under 16 years, the prescriber may also need to meet other legal obligations, e.g. authorisation under s175 of the Children and Young Persons (Care and Protection) Act.

Medical Practitioners may contact Pharmaceutical Services on (02) 9391 9944 or email MOH-PharmaceuticalServices@health.nsw.gov.au for more information on NSW authorities to prescribe medicines.

The NSW Cannabis Medicines Advisory Service

The NSW Cannabis Medicines Advisory Service is available to assist medical practitioners in NSW with applying for authorisation to prescribe. Medical practitioners can contact the Service by email HNELHD-CMAS@hnehealth.nsw.gov.au or telephone (02) 4923 6200.

The Service can also provide medical practitioners with up-to-date information about managing the symptoms their patients are experiencing, and any clinical trials using cannabis medicines that might be relevant.

A TGA review of the current clinical evidence for cannabis medicines in paediatric and adult epilepsies, multiple sclerosis, nausea and vomiting resulting from chemotherapy and HIV/AIDS therapy, pain, and palliative care is available on the TGA website.

The NSW Cannabis Medicines Advisory Service will be closed from Monday 24 December 2018 to Friday 4 January 2019. NSW Health will continue to process applications to prescribe S8 cannabis medicines as usual on business days (excluding public holidays) during this period.

Requirements on the prescriber

To prescribe and supply a Schedule 8 cannabis medicine, the prescriber must:

  • be a registered medical practitioner who may lawfully prescribe scheduled medicines in NSW; and
  • be authorised by the Secretary, NSW Health, to prescribe that particular product for a particular patient (or a particular group of patients in case of an approved clinical trial); and
  • be approved by the Secretary, Commonwealth Department of Health to import and/or supply that particular product under the Commonwealth’s:
    • Special Access Scheme Category (for a particular patient), or
    • “Authorised Prescriber” scheme (for a particular group of patients), or
    • Clinical Trial schemes (for a particular group of patients)

The prescriber or pharmacist who will supply the product must either:

  • obtain a licence and a permit to import the unregistered product, issued under the Customs (Prohibited Imports) Regulation by the Commonwealth Office of Drug Control (ODC); or
  • obtain the product from an importer holding both a licence from NSW Ministry of Health (or the equivalent authority in its home State or Territory)  to supply the product by wholesale, and a licence and a permit to import the product issued by the ODC; or
  • obtain the product from a manufacturer licensed by the TGA, the ODC and the NSW Ministry of Health (or the equivalent authority in its home State or Territory) to manufacture the product.

The TGA publishes a flowchart that summarises the requirements for an Australian registered medical practitioner to access medicinal cannabis products.

Requirements on the product

The product applied for must have been lawfully manufactured or imported, i.e. under a Commonwealth licence or an approval. The application must include full details of the product including its form, composition, and administration. Some cannabis-based products have been formally assessed for quality, safety and efficacy by a medicines regulator in Australia or another country, including:

  • Nabiximols (Sativex®) for managing spasticity associated with multiple sclerosis
  • Dronabinol for anorexia in AIDS patients and chemotherapy-induced nausea and vomiting
  • Nabilone for chemotherapy-induced nausea and vomiting.

Applications to prescribe are not limited to such products. However the product applied for must be legally produced and manufactured to appropriate quality standards.

The Commonwealth can license cultivation, production, manufacture and supply of cannabis and its products for therapeutic use. A NSW based manufacturer must also hold a licence issued by NSW Health to manufacture a cannabis medicine and supply it by wholesale.

The cannabis medicine must be derived naturally from the cannabis plant, not synthesized (with the exception of the synthetic products dronabinol and nabilone which have been assessed by a foreign medicines regulator).

Products that might be accessed from unregulated sources, including oils, tinctures and plant material, are of unknown safety and efficacy and may include harmful substances and contaminants. These will not be authorised.

A cannabidiol preparation for therapeutic use, where cannabidiol comprises 98 per cent or more of the total cannabinoid content of the preparation, and which contains no more than 2% of other naturally-derived cannabinoids as impurities in the cannabidiol component, is a Schedule 4 medicine. Currently, there are no registered cannabidiol preparations in Australia. Whilst a NSW authority is not required to prescribe an unregistered Schedule 4 substance, the other requirements for unregistered cannabis medicines apply, e.g. Commonwealth licences to import/manufacture and TGA approval (under SAS Category B, Authorised Prescriber or Clinical Trial schemes) are still required.

Writing a prescription

The medical practitioner must specify on the prescription for a Schedule 8 cannabis medicine:

The medical practitioner must make a prescribing record as for any Schedule 8 prescription.

Dispensing

A pharmacist can dispense a prescription for a Schedule 8 cannabis medicine (other than Schedule 4 cannabidiol) only if the prescriber is authorised by NSW Health to prescribe it.

The prescription cannot be legally dispensed unless it bears the NSW authority number and other details described above written by the prescriber.

A pharmacist can dispense only on receipt of a hard copy written prescription. (Emergency supply provisions do not apply.) Hospital pharmacies may supply for inpatients on a copy of a medication chart order.

The other usual requirements as for Schedule 8 prescriptions apply, e.g. the pharmacist must verify the prescriber, must report any apparently forged or fraudulently altered prescriptions, and must retain the dispensed prescription, separately from other prescriptions.

Cannabis medicines supplied to a patient (by a pharmacy or medical practitioner) must be labelled with a dispensing label with the usual details for any dispensed medicine including name of the product, prescription number, patient name, directions for use, date of supply, name and address of supplier.

A pharmacy (or medical practitioner) cannot hold stocks of a cannabis medicine (other than Sativex®) in anticipation of an authority being issued to the medical practitioner to prescribe the product for supply from that pharmacy.

It should be noted that a pharmacy (or medical practitioner) cannot hold stock of any unregistered medicine unless it has been specially permitted by the Commonwealth as a substitute for a registered medicine.

All supplies and receipts of Schedule 8 cannabis medicines (whether dispensed on prescription or supplied directly by a medical practitioner) must be recorded in a drug register. If used in a clinical trial, a record of the NSW authority number must be made in the clinical trial records.

For further information see the Guide to Poisons and Therapeutic Goods Legislation for Pharmacists.

Any loss or theft of Schedule 8 cannabis medicines must be reported to the Secretary, NSW Health, on the Notification of Loss or Theft of Accountable Drugs (S8 and S4D substances) form as for all Schedule 8 drugs. Unwanted cannabis medicines may not be destroyed except by a person authorised to destroy Schedule 8 drugs.

Manufacture

Cultivation, production and manufacture of cannabis and its products require licences under the Commonwealth Narcotic Drugs Act and Therapeutic Goods Act. Detailed information on Commonwealth licences can be found on the TGA website. Manufacture of each cannabis medicine also requires a licence under the NSW Poisons and Therapeutic Goods Act. A NSW licence must be obtained first, using the Application for a Licence to Manufacture and Supply by Wholesale, Drugs of Addiction.

The TGA is responsible for the regulation of the quality aspects of cannabis medicines. The TGA's Therapeutic Goods Order No. 93 - Standard for Medicinal Cannabis (TGO 93) provides controls aiming to ensure acceptable quality of cannabis medicines and ingredients used in their manufacture.

Import

A company located in NSW may import unregistered cannabis medicines if licensed to supply by wholesale under the Poisons and Therapeutic Goods Regulation 2008 (NSW), and if compliant with Commonwealth law including the Therapeutic Goods Act 1989, Customs (Prohibited Imports) Regulation 1956, and/or the Narcotic Drugs Act 1967. Compliance to conditions of any licence is mandatory.

A medical practitioner or pharmacist may also import cannabis medicines where the supply is authorised under the Poisons and Therapeutic Goods Act 1966 and approved by the Commonwealth to access unregistered cannabis medicines.

For further information on Commonwealth requirements, visit the websites for the Therapeutic Goods Administration and  The Office of Drug Control.

 

Supply by wholesale of cannabis medicines

In NSW, to supply by wholesale a cannabis medicines in Schedule 4, or to manufacture and/or supply by wholesale a cannabis medicine in Schedule 8, for human therapeutic use, you must hold a licence under the Poisons and Therapeutic Goods Regulation 2008. Supply by wholesale is defined as supply for the purpose of re-supply to a third party, such as to a medical practitioner or a pharmacist.  
 
If you wish to supply by wholesale a cannabis medicine in Schedule 4, you must submit an  Application for a Licence to Supply by Wholesale Poisons and/or Restricted Substances and fill in the  cannabis supplementary pages.
 
If you wish to supply by wholesale a cannabis medicine in Schedule 8, you must submit an  Application for a Licence to Supply by Wholesale Drugs of Addiction and fill in the  cannabis supplementary pages.
 
If you wish to manufacture and supply by wholesale a cannabis medicine in Schedule 8, you must submit an  Application for a Licence to Manufacture or Supply by Wholesale Drugs of Addiction and fill in the  cannabis supplementary pages.
Supply by wholesale of cannabis medicines must comply with NSW Licence conditions, as well as Commonwealth Licence conditions under the Therapeutic Goods Act 1989, and/or the Customs (Prohibited Imports) Regulation 1956, and/or the Narcotic Drugs Act 1967.
For further information on Commonwealth requirements, visit the websites for the Therapeutic Goods Administration and The Office of Drug Control.
Companies with exsiting wholesale licences for Schedule 8 drugs need to apply to NSW Health for amendment of their licence in order to supply cannabis medicines, and must provide a revised procedure which may include refrigerated storage of Schedule 8 products, where required.
Note that it is not possible for the premises of a pharmacy (or medical practitioner’s place of practice) to also be the licensed premises of a wholesale Schedule 8/ Schedule 4 medicine supplier. Separate premises, capable of complying with the provisions of the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 are required.

Assessing the product

Before applying for a NSW Licence, an assessment of the product must be undertaken to ensure that obligations under State and Commonwealth laws are met. The Therapeutic Goods Administration (TGA) has published detailed information on access to unregistered medicinal cannabis products. The Office of Drug Control has also published detailed information on the importation, exportation, cultivation, production and manufacture of medicinal cannabis products. It is recommended that a Regulatory Affairs Consultant is engaged to assist in the process of applying for a licence, including assessing the product for eligibility for supply.
You must confirm that the product is a therapeutic good for human therapeutic use, and not a food or a cosmetic. The TGA has established SME Assist, an assessment tool to assist in assessing if a product is a therapeutic good for therapeutic use.
The product must be included in Schedule 4 or in Schedule 8 of the NSW Poisons List, i.e. the Poisons Standard. You will need to furnish a Certificate of Analysis that shows the total cannabinoid content of the product to be able to determine the schedule of the product. A cannabis medicine is in Schedule 4 if the cannabidiol content is >98% of total cannabinoid content. If the product is not for human therapeutic use, it is in Schedule 9 and prohibited under Schedule 1 of the NSW Drug Misuse and Trafficking Act and cannot be manufactured or supplied by wholesale under a NSW Licence.
The product must comply with TGO 93 – Standard for Medicinal Cannabis. The Therapeutic Goods Administration will require a certification of compliance to the Standard before the product can be supplied.
Some governments do not allow the export of cannabis products. Approval must be granted by the national governments of both the importing and exporting countries. Please refer to information published by the ODC to assist you in the import and export of the cannabis product.
If you hold a licence to cultivate, produce and/or manufacture under the Narcotic Drugs Act 1967, or a licence to manufacture in accordance with the Code of Good Manufacturing Practice (GMP) under the Therapeutic Goods Act 1989, or a Customs Licence to import, a copy of these licences must be provided with an application for a NSW Licence.
An application for a NSW Licence must be submitted with a full company extract obtained from the Australian Securities and Investment Commission, statutory declaration forms, fitness and probity check forms, and National Criminal Record Check certificates.
For further information on the application process see the website of the Regulation and Compliance Unit.

Drugs and Poisons Control Procedure

Upon receipt of a completed application form, a Drugs and Poisons Control Procedure template will be provided to the applicant for completion, to describe the proposed handling of the cannabis medicine in compliance with the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2,3,4 and 8(the Code) and the Poisons and Therapeutic Goods legislation. The Code requires that a Security Risk Assessment of the business premises be prepared by a licensed security service provider, and for a Risk Management Plan to be developed.
Standard requirements for handling Schedule 8 drugs include storage in a strongroom or safe with restricted access, maintenance of a drug register, tamper-evident packaging of products, procedures for signed orders by authorised persons, consignment and receipt procedures, and packaging of orders.
An inspection of any proposed premises by NSW Health is undertaken prior to a licence being issued. On receipt of all satisfactorily completed documents and the proposed premises are found to be suitable, NSW Health will generally issue a licence within 20 business days. Licences are subject to conditions. 

Approval process

The approval process will take up to four weeks from the date the NSW Ministry of Health receives the completed application. This includes the time taken for assessment, interviews and inspection if required. An application for a licence to manufacture or supply cannabis can be refused if the Secretary, NSW Health, is of the opinion that the applicant is not a fit and proper person to hold the licence or that the premises are not appropriate for the manufacture or supply of cannabis by wholesale.
Where an applicant submits an incomplete application or  has not provided any further documentation which has been requested, the approval process will be delayed. More information about the approval process including the timeframes for the different phases of the process can be found on the “Processing times” page of the website.

After submission of the completed form, the applicant will be provided with a written acknowledgement of the application. The acknowledgement will include a request for omitted or incomplete documents if required. Once all documents have been received, assessment of the application will take place and a recommendation will be made to either grant or refuse the application. If the recommendation is to approve the granting of the licence, the licence will be issued to the applicant. If the recommendation is to refuse the granting of the licence the reasons for the refusal will be provided to the applicant.

For further information on the application process see the website of the Regulation and Compliance Unit.

 

Storage

Cannabis medicines must be stored separately and securely, as is required of Schedule 8 drugs. Some products may require refrigeration and information on storage details is available.

Patients

Patients who believe a cannabis medicine may be helpful to their condition should consult their General Practitioner for advice. For further information patients may contact the Centre for Medicinal Cannabis Research and Innovation.

General

A patient or his/her carer may receive, possess and administer a cannabis medicine which has been legally imported/manufactured and prescribed for him/her.

Cannabis medicines supplied in or from NSW (other than when dispensed to a patient) must be packaged and labelled as Schedule 8 drugs (unless a Schedule 4 cannabidiol product), unless otherwise exempted by the Secretary, NSW Health.

It is illegal to label a product suggesting it is a cannabis product if it is not.

Contact details for further information

NSW

For general enquiries, contact:
Centre for Medicinal Cannabis Research and Innovation
GPO Box 5477
Sydney NSW 2001
Phone 1800 217 247 (toll free)

Patients and members of the public can also call the Cannabis Medicines help line (toll free within Australia)
Phone: 1800 217 257

For medical practitioner and other health practitioner enquiries about using a cannabis medicine to treat a patient, contact:
NSW Cannabis Medicines Advisory Service
Phone: (02) 4923 6200
Email: HNELHD-CMAS@hnehealth.nsw.gov.au

For medical practitioner enquiries about authorisations to prescribe, contact:
Chief Pharmacist Unit, Ministry of Health
Phone: (02) 9391 9944
Email: MOH-PharmaceuticalServices@health.nsw.gov.au

For enquiries about NSW licences to manufacture and/or supply cannabis medicines by wholesale, contact:
Email: MOH-PharmaceuticalServices@health.nsw.gov.au

Commonwealth

For enquiries relating to the importation, cultivation, production and manufacture of cannabis medicines, contact:

The Office of Drug Control
Phone: (02) 6232 8433 for general enquiries regarding the cultivation of medicinal cannabis
Phone: (02) 6232 8648 for enquiries relating to completing a medicinal cannabis manufacturing or import licence/permit application
Phone: (02) 6232 8740 for all other enquiries

For enquiries relating to products not approved for use in Australia, contact:

Therapeutic Goods Administration (TGA)
Phone: (02) 6232 8106 or email clinical.trials@health.gov.au for enquiries about clinical trials
Phone: (02) 6232 8644 or email SAS@health.gov.au for enquiries about the Special Access Scheme
Phone: (02) 6232 8866 for enquiries about the Authorised Prescriber scheme

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Page Updated: Wednesday 12 December 2018
Contact page owner: Pharmaceutical Services