EMS NanaBisTM

The purpose of this webpage is to educate and inform healthcare professionals about NanaBisTM.


NanaBisTM is a non-ARTG product currently in clinical trial and available under SAS.

SAS application can be made either manually via the appropriate application forms or on-line via https://sas.tga.gov.au

For more information, please call:
Within Australia: 1300 943 467
Outside Australia: +61 2 8203 9523


NanaBisTM is an investigative new product containing 1:1 ratios of Cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), in a sub-micron spray applied to the oro-buccal membrane.

NanaBisTM Interim Guidance to Practitioner can be found here..


Ethics Approval

The consumer medical information (CMI) is available here (ENGLISH), CMI (ITALIAN), CMI (JAPANESE), CMI (ARABIC), CMI (CHINESE SIMPLIFIED), CMI (FRENCH).

Chances are you have come to this page because a patient presented to you has a MED IDENT bracelet on his or her wrist. A bracelet is provided with the investigational product to every patient, and its strongly recommended that the patient wear these at all times. Should the patient misplace or damage their bracelet, Medlab will be happy to replace at no charge.

These bracelets look like this:

Bracelet part one
Bracelet part two

 

 

Requirements in each Australian state for prescribers to gain access to Schedule 8 Medicinal Cannabis

 

Overview

 

State / Territory

 

Required document (form) to be submitted

 

Public document

ACT

Application for approval to prescribe medicinal cannabis

YES

NSW

TGA Special Access Scheme – Category B (Medicinal Cannabis NSW)

YES

NT

Notification of Supply of an Unrestricted S8 Substance

YES

TAS

Authorisation to prescribe medical cannabis (unregistered cannabinoid products)

NO

QLD

Application for a Medicinal Cannabis Approval

YES

SA

Authority Application to prescribe a Schedule 8 medicinal cannabis drug

YES

VIC

Application for a Schedule 8 treatment permit

Online Form

WA

Application for authorisation - Cannabis Based Products

YES

 

 

Description

 

 

State / Territory

 

Requirements and procedures

 

Link to documents

 

ACT

 

On 2 March 2018, the NSW and Commonwealth governments announced a change in the prescribing process in NSW to improve individual patient access to unregistered cannabis medicines by introducing a single application process.

NSW Health relies on a single clinical assessment by the Therapeutic Goods Administration (TGA) under the Special Access Scheme and confines its review to checking the credentials of the prescribing doctor and the patient history, as with any other Schedule 8 drug authority. The joint application form captures both the relevant requirements for the TGA SAS Category B application and the NSW Health authority application form. Medical practitioners must submit the application to the TGA but are not required to also provide a copy of the application form to NSW Health.

Pharmacists may need to apply to the TGA and the Office of Drug Control to seek approval to obtain medicinal cannabis.

 

Application for approval:

Medicinal Cannabis 

 

General information:

ACT Health

 

 

NSW

 

On 2 March 2018, the NSW and Commonwealth governments announced a change in the prescribing process in NSW to improve individual patient access to unregistered cannabis medicines by introducing a single application process.

NSW Health relies on a single clinical assessment by the Therapeutic Goods Administration (TGA) under the Special Access Scheme and confines its review to checking the credentials of the prescribing doctor and the patient history, as with any other Schedule 8 drug authority. The joint application form captures both the relevant requirements for the TGA SAS Category B application and the NSW Health authority application form. Medical practitioners must submit the application to the TGA but are not required to also provide a copy of the application form to NSW Health.

 

Information:

Special Access Scheme: NSW/TGA medicinal cannabis forms

 

Note: No requirement to provide a copy of this application form to NSW Health

 

SAS online system

https://sas.tga.gov.au

 

Northern Territory

 

To date the NT has not applied additional controls to pharmaceutical cannabis products.

Authorisation from NT Chief Health Officer (CHO) is not required for all goods in Schedule 8 other than the ones declared as restricted (see link for a full list). However, a prescriber needs to send a notification to the NT CHO if the patient is going to be on the unrestricted S8 medicine for more than 8 weeks, or has already been on the medicine for 8 weeks with another prescriber (notification form on the NTG website).

 

Notification:

Medical practitioners and schedule 8 medicines

 

 

Tasmania

The Tasmanian Government has developed a medical cannabis controlled access scheme (CAS). The scheme will allow only relevant medical specialists to be authorised to prescribe medical cannabis (unregistered cannabinoid products) in limited circumstances where conventional treatment has been unsuccessful. Please note that only public hospital consultants or visiting medical officers/VMOs (medical practitioners in private practice who also provide medical services in a public hospital) can be approved to prescribe these products. If a GP believes an unregistered medical cannabis product is indicated based on a risk/benefit assessment, referral to a relevant specialist medical practitioner in the relevant field of medicine is required. The Relevant Specialist Medical Practitioner must then apply to the Secretary of the Tasmanian Department of Health and Human Services (DHHS), for authorisation to prescribe unregistered medicinal cannabis products. Please note that the application form is available on the Tasmanian Health System (THS) intranet page (it is not a public document). The application is reviewed by a delegate of the Secretary of DHHS under the Poisons Act 1971. Application or notification to the TGA and/or the Office of Drug Control is required in parallel.

Once the authority to prescribe unregistered medicinal cannabis products is issued, the Relevant Specialist Medical Practitioner prescribes a product for a patient in accordance with their authority and the product is dispensed by a Tasmanian Health Service (THS) Hospital Pharmacy.

General information:

Unregistered Medical Cannabis Products Access Flowchart - For Health Professionals

And

Department of Health and Human Services

And

·       Publications

 

Queensland

 

A medical practitioner must apply to the Chief Executive (CE), Department of Health, for a medicinal cannabis approval in Queensland. This approval authorises the medical practitioner to treat an individual patient with a specified medicinal cannabis product. The CE may request advice from the Queensland Medicinal Cannabis Expert Advisory Panel. Specialists that wish to become a patient-class prescriber will need patient-class approval.

Once the medicinal cannabis approval is granted, it is valid for up to one year. The prescriber must then apply to the TGA for supply of the product under SAS scheme or AP scheme, before the medicinal cannabis product can be prescribed (medical practitioner) and dispensed (pharmacist) to the patient.

 

Application for approval:

Prescribing medicinal cannabis

 

Further information:

Queensland Government

 

SAS online system

https://sas.tga.gov.au

 

 

South Australia

 

A medical practitioner in South Australia must apply for approval to prescribe a Schedule 8 medicinal cannabis drug through the Drugs of Dependence Unit.

Schedule 8 medicinal cannabis products are being treated in the same way as other schedule 8 drugs, i.e. medical practitioners must apply for a Controlled Substances Act authority to legally prescribe the drug. This covers the prescriber under South Australia’s controlled substances legislation.

 

Application for approval:

Medicinal cannabis

 

Further information:

SA Health

 

Victoria

 

A medical practitioner must obtain a Schedule 8 treatment permit from the Victorian Department of Health & Human Services before prescribing a Schedule 8 medicinal cannabis product in Victoria.

Treatment permits to prescribe an unapproved medicinal cannabis product will generally only be approved where the applicant has obtained TGA approval to prescribe that product to the patient.

 

Application for permit:

Victorian Schedule 8 Treatment permit 

And

Schedule 8 permits

 

Further information:

Health.vic

 

SAS online system

https://sas.tga.gov.au

 

Western Australia

 

Approval from the WA Department of Health is required to prescribe any cannabis-based product in Schedule 8. There are two pathways:

• Notification pathway - specialist prescribers can apply for a class approval

• Authorisation pathway - specialists can apply for treatment of individual patients on the basis of other indications.

The notification pathway is currently limited to treatment of multiple sclerosis, but is likely to be expanded as evidence accumulates for efficacy in other conditions. A specialist can appoint a General Practitioner as a co-prescriber.

A patient can present an approved prescription to any WA pharmacy for dispensing. Pharmacies can obtain products from licensed manufacturers or approved sponsors acting as pharmaceutical wholesalers

 

Application for authorisation:

Government of Western Australia

 

Further information: Government of Western Australia

 

 

 

Summary S8 Medicinal Cannabis Products – state level

 

 

 

State / Territory

 

 

 

GPs

 

Specialists

 

Process

 

ACT

 

 

Yes, with specialist support

 

Yes

 

Specific process

 

NSW

 

 

Yes

 

Yes

 

Application to TGA (SAS Category B),

No application to NSW Health

 

NT

 

 

Initial application made by specialist, then GP ongoing

 

Yes

 

Standard S8 process

 

TAS

 

 

No

 

Yes

 

Specific process

 

 

QLD

 

Single patient

 

Yes, with longitudinal treating relationship with the patient

 

Yes

 

Application to CE of QLD Health

 

Patient class (CINV, palliative care, resistant paediatric epilepsy)

 

No

 

Yes (certain specialists)

 

Must follow QLD clinical guidance (no application)

 

SA

 

 

Yes, with specialist support

 

Yes

 

Standard S8 process

 

VIC

 

 

General S8

 

 

Yes

 

 

 

Yes

 

 

Standard S8 process

WA

 

Authorisation (like TGA SAS CatB)

 

Yes, with specialist support

 

Yes

 

Specific process

 

Notification (like TGA AP Scheme)

 

Initial application made by specialist, then GP ongoing

 

Yes

 

Specific process


Access to medicinal cannabis products: Assistance for Doctors re SAS and AP

Medicinal Cannabis Section at TGA:

call 1800 220 007 (or 02 6232 8866),

or email to: medicinal.cannabis@health.gov.au,

or seek further information available on the following websites:

Special Access Scheme: NSW/TGA medicinal cannabis forms

https://www.tga.gov.au/access-medicinal-cannabis-products

https://www.odc.gov.au/medicinal-cannabis

https://www.tga.gov.au/access-medicinal-cannabis-products-steps-using-access-schemes