A GUIDE TO NAVIGATING THETGA SPECIALACCESS SCHEMEPORTAL

A GUIDE TO NAVIGATING THE TGA SPECIAL ACCESS SCHEME PORTAL

• OVERVIEW OF THE APPLICATION PROCESS

• ROADMAP

• STEP 1: PRESCRIBER DETAILS

• STEP 2: PRODUCT SELECTION

• STEP 3: STATE APPROVALS

• STEP 4: PRODUCT DETAILS

• STEP 5: PATIENT DETAILS

• STEP 6: OUTCOME LETTER

• FOR REPEAT SAS APPROVALS

For any enquiries or questions, please contact our Medical Information Hotline: 1800 223 842

S8 prescription requirementsapply for all SpectrumTherapeutics products

Overview of the application process

*State approvals/permits may not be

required for some states and territories.

Please refer to the relevant state health

department website for further information

Patient consult and screening to determine if medicinal cannabis is

appropriate

Lodge application for TGA approval and

state approval (where required) via the TGA

SAS portal#

Once TGA and State approval* has been obtained,

you are legally permitted to write a medicinal cannabis

prescription

Provide a copy of theprescription and TGA SAS

approval letter to thepharmacist. The pharmacist will

require both documentsto dispense the medication

NOTE: A copy of the prescription is not required to order the medicine.Documents and information required to order a Spectrum Therapeutics Medicinal Cannabis medicine are: TGA approval document, patient initials, product and quantity of product required.

Step 1: Prescriber Details

A. Log onto the TGA online website: http://sas.tga.gov.au

• On the website, click Register Now.

• Create username and password.

• You will need to enter in your AHPRA number and enter in your clinic details.

• You will also need to activate your account via SAS link to sent to your email inbox.

B. Once you’ve created an account, you will be able to control and manage all your SAS applications.

• To apply for your patient, click on New SAS submission.

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C. If you are affiliated with another Site (i.e. work at another clinic), you may also link your online portal to this clinic.

D. Your details will be automatically populated from the account which was registered through the system, as shown below. Note: contact details may be amended prior to continuing.

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Step 2: Product Selection

E. Select the therapeutic good type for which unapproved access is being applied for. Note: medicinal cannabis is a medicine.

F. Under the Medicine category, enter the product you’d like to prescribe. A look-up function is available to search TGA’s internal database of existing entries as shown below:

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G. To choose the right product, enter in the brand name of product – not active ingredient. For example: to search for Spectrum products, enter ‘Spectrum’ into the search button.

H. A list of all Spectrum products should be displayed. Select the product you intend on prescribing for the patient.

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I. Select the appropriate dosage form. The dosage form e.g. flowers, oil or softgel capsules will automatically be displayed when you click on the look-up function.

J. Enter the Indication that you will be applying for. The TGA has a list of indications that have been approved via the SAS scheme on their website. Indications include (but not limited to):

• Chronic Pain (non-cancer, neuropathic, cancer pain)

• Cancer symptoms (Nausea, Vomiting, Sleep disturbance, Appetite)

• Palliative symptoms

• Anxiety (General, Social Anxiety Disorder)

• MS Spasticity

• PTSD

• Tourette’s Syndrome

• Autism

• Epilepsy

• Others: Chronic Migraine pain, Arthritis Pain, Rheumatoid Pain, Fibromyalgia, Endometriosis

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K. You will be prompted to confirm whether the patient meets the definition of a SAS Category A patient. The answer to the below determines whether the submission is processed as a SAS Category A notification or SAS Category B application. Note: the majority of medicinal cannabis applications are SAS Category B applications.

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Step 3: State Approvals

L. Select your appropriate State Health department. Note: if your state is not listed on the TGA portal, you must apply directly to your Health Department if required.

For further information regarding state applications/permits/authorities, please refer to the specific state health department website:

State Reference link

VIC https://www2.health.vic.gov.au/about/publications/factsheets/medicinal-cannabis-access-practitioners

NSW https://www.health.nsw.gov.au/pharmaceutical/cannabismedicines/Pages/default.aspx

QLD https://www.health.qld.gov.au/public-health/topics/medicinal-cannabis/clinicians/prescribing

WA https://ww2.health.wa.gov.au/Articles/A_E/Cannabis-based-products

SA

https://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/

health+topics/health+conditions+prevention+and+treatment/medicines/medicinal+cannabis/

medicinal+cannabis+patient+access+in+south+australia

TAShttps://www.dhhs.tas.gov.au/psbtas/publications/medical_cannabis/medical_cannabis_

controlled_access_scheme

NThttps://health.nt.gov.au/professionals/environmental-health/therapeutic-medicines-containing-

cannabinoids-medicinal-cannabis

ACThttps://www.health.act.gov.au/health-professionals/pharmaceutical-services/controlled-

medicines/medicinal-cannabis

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Regulatory Process

and Approvals Required

VIC NSW QLD WA SA TAS NT ACT

Medical Practitioner

(GP or Specialist)

GP and/or Specialist

GP and/or Specialist

GP and/or Specialist

GP and/or Specialist

GP and/or Specialist

Specialist Only

GP and/or Specialist

GP (with letter of support

from Specialist)

TGA Online Application

YES YES YES YES YES NO YES YES

State Health Permits /

AuthorisationsYES

NO – Unless

prescribing for a drug dependent person, a child < 16 years of

age or for a clinical trial

NO – Unless

prescribing for a drug dependent person and

if doctor does not hold a

specialist registration

YES

NO – Patient can be put on a 60-day trial prior to seeking

state health approval, if they are not on any other S8

medication

Authorisation required for Schedule 4

and Schedule 8 cannabis medicines.

All applications assessed on a case by case basis by a

multidisciplinary expert panel of clinicians and

dispensed from TAS Health

Service pharmacies only.

NO – However a notification to NT Chief

Health Officer is

required if the patient is on S8 for 2+

months

YES

Letter of Support from

Specialist

NO – Unless applying for an indication

outside of their regular

practice

NO NO

NO*Specialist approval

required for prescribing to patients < 16 years and those

with a history of drug

dependence.

NO - NO YES

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Overview of Federal and State based ApprovalsState approval/permits required for some states and territories are subject to change. Please refer to the relevant state health department website for further information.

All state health permits/authorisations can be applied for via the TGA online SAS portal (except for TAS).

All SAS applications for medicinal cannabis products require HCPs to provide a clinical justification and a monitoring plan. Patient consent should be obtained before prescribing medicinal cannabis. In WA, GPs will still be required to seek specialist approval when prescribing for children under the age of 16 and for patients who are drug dependent or have a history of drug use. NSW Health Approval is not required except if the patient is under 16 or prescribing to a drug dependent person. QLD Health Approval is required for non-specialist doctors. RACGP doctors are recognised as Specialists according to Queensland Health. Current as of January 2020.

Applications in ACT may be approved for the following conditions: Spasticity in multiple sclerosis, Nausea and vomiting related to cancer chemotherapy; Pain and/or anxiety in patients with active malignancy of a life limiting disease where (in either case) the prognosis might reasonably be expected to be 12 months or less; Refractory paediatric epilepsy. Other conditions may be considered subject to further review.

Step 4: Product Details

M. Enter the following information in the product details fields:

• Dosage: please specify maximum daily dose in mg.• Example only: For Spectrum Yellow: 0.25ml at bd, titrated towards therapeutic relief, maximum 100mg daily.

• Expected duration of treatment: GPs generally seek approval for 1, 3 or 6 months. Specialists can seek approval for up to 12 months.

• Duration unit: specify ‘weeks’ or ‘months’.

• Intended date of supply: recommend entering the next business day as date of supply.

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Step 5: Patient Details

N. Enter in patient details to complete the application.

O. Enter in diagnosis, justification and intended monitoring. See below for suggested wording.

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Example of clinical justification template:

Patient has been diagnosed with <enter diagnosis>, experiencing symptoms of <X>,

<Y> and <Z>. Patient has been trialed on approved therapeutic agents such as

<enter past ARTG medications that have failed>. However, all these treatments and

modalities have failed to provide therapeutic relief for my patient. Moreover, my

patient has experienced <enter adverse reactions from approved products, if any>.

Therefore, I would like to trial my patient on <enter unapproved cannabis name> in

order to improve symptoms and overall quality of life. I declare that I am the patient’s

primary treating physician and patient <is/is not> under specialist care. <If patient is

under Specialist care, please indicate whether Specialist is aware and supportive of

this application>

Monitoring:

Example of monitoring plan: I will be monitoring this patient on a monthly basis,

utilizing the following assessment tools:

• Numerical Pain Score

• QoL

• Blood tests

• Patient Dosing Diary

• Any other methods of monitoring

P. Enter additional patient details for state applications.

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Q. Enter in prescriber qualifications and any supporting information, including recent specialist reports.

If you are applying for an indication that is not listed on the TGA website, you can upload clinical papers to support your application.

R. Submit your application Acknowledge that you have read and understood the following disclaimer to submit the SAS application to

the TGA:

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S. You will receive an email with your submission receipt.

Once your application has been approved, you will receive another email with your TGA Approval document and relevant State Health department Authority (if applicable).

T. Ensure you have attained informed consent from your patient, and explained to your patient all legalities around the use of medicinal cannabis prescriptions including driving restrictions if applicable.

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These images are an example of the TGA SAS letter and Victorian State health permit approval

Step 6: Outcome LetterU. You will have the ability to download receipts and outcome letters provided by the

TGA through their dashboard. This can be done on a single submission basis or a bulk download by selecting the submissions of interest as shown below:

V. Once you have attained informed written consent and have received Approvals documents from both TGA and State Health, you are now legally permitted to write the prescription.

W. Patient will then take the prescription and TGA SAS approval letter to the pharmacy.

This guide has been developed to assist you in navigating the SAS portal. Instructions, images and processes included in the document make reference to TGA’s Online System Guidance Document (Sept 2018). For further information on how to navigate the SAS portal, please refer to the TGA SAS Portal Online Guide which can be found at: https://www.tga.gov.au/sites/default/files/special-access-scheme-sas-online-systemguidance.pdf

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For Repeat SAS ApprovalsCloning Submissions 

All SAS submissions that are visible in the dashboard can be cloned. The purpose of this function is to reduce the administrative burden of re-entering identical information into renewal submissions, or submissions for frequently used unapproved goods. 

It is the responsibility of the healthcare professional to review all the information copied to the cloned submission to ensure the information is accurate and up to date before submitting to the TGA. 

The following information will not be pre-populated into the new draft: 

1. Answer to whether the patient’s condition meets the SAS Category A definition (‘yes/no’)

2. Intended date of supply 

3. Any attachments uploaded with the original submission 

4. Answer to the privacy statement on the Summary step (‘yes/no’) 

5. Any state or territory requirements

6. Dosage form, Indication- select from the drop down menu

7. Previous SAS number if available

The following information will need to be reviewed as they relate to the patient:

1. Patient Details

2. Diagnosis

3. Clinical Justification

Note: The information specific to the State or Territory Health Department for medicinal cannabis submissions will not be copied in the new draft submission. If State or Territory Health Department approval is required, this information will need to be provided as per Step 3 before submitting. 

Spectrum Therapeutics™ medicinal cannabis products are not registered in Australia. Spectrum Therapeutics™ products are SCHEDULE 8 drugs NON-ARTG medications. Spectrum Therapeutics Pty Ltd. ABN 50 623 556 258. Suite 3, Building 26, 270 Ferntree Gully Road, Notting Hill VIC 3168.TM Trademark | Date of preparation: February 2020. SPT/056/02-20

spectrumtherapeutics.com

medinfo.au@canopygrowth.com

1800 223 843