EMS NanaBisTM

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


Emergency medical support is offered to healthcare professionals on these numbers:

Within Australia: 1300 943 467
Outside Australia: +61 2 8203 9523


If you are a patient and you believe you are having an adverse reaction you MUST immediately call your Doctor or have a friend or family member drive you to the closest hospital emergency room.

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

NanaBisTM product information can be found here.


Ethics Approval
Ethics Approval

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 via http://mcmp.com.au/


Ethics Approval


Principal Investigator


NanaBisTM is being studied as both an adjuvant and a replacement to opioid therapy in advanced cancer pain. ANZCTR listing is available here.

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

Information leaflet for medical practitioners on how to arrange supply of Medicinal Cannabis for a patient

 

 

  • Requirements in each Australian state for prescribers to gain access to Schedule 8 Medicinal Cannabis (NanaBis™ and NanaBidial™)
  •  

    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)

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

    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

     

    To prescribe cannabis as a Schedule 8 controlled medicine, prescribers must obtain approval from the ACT Chief Health Officer (CHO) through the same process which currently applies for other controlled medicines such as opiates and amphetamines. A prescriber can apply for an approval to prescribe for one of their patients or for a category approval for medicinal cannabis to streamline processing of their application. Applications should be in accordance with Category 6 – Medicinal Cannabis in the ACT Controlled Medicines Prescribing Standards. Prescribers may submit their application at the same time as their TGA application, however applications will not be approved by ACT Health until TGA approval has been obtained.

    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

     

    From March 2018, NSW Health relies on the Special Access Scheme – Category B (Medicinal Cannabis NSW) application.

    Authorisation from the Secretary, NSW Health, is not required any more to access, prescribe and supply a medicinal cannabis product for a single patient in NSW.  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. However, this procedure does not apply to patient class / clinical trial applications in NSW.

     

    Information:

    Special Access Scheme: NSW/TGA medicinal cannabis forms

     

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

     

     

     

    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

     

     

     

     

     

    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

     

     

    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, with specialist support

     

    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 23,

    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