Overview: Special Access Scheme (SAS) 

 

​The Special Access Scheme (SAS) is a national scheme administered by the Experimental Products Section of the Therapeutic Goods Administration (TGA), a division of the Health Department, Canberra.  

 

In accordance with provisions of the SAS, potentially any cannabis, cannabis resin and cannabinoid product can be supplied in Australia via the SAS as long as the manufacture, prescription, possession, sale, supply or use is not prohibited by State or Territory law. 

 

In accordance with good medical practice, the medical practitioner needs to educate him/herself about the SAS and the "unapproved" cannabis product before applying to use cannabis to treat his or her patient. Medical practitioners have the right to refuse to obtain the product if he/she believes there is either insufficient clinical justification or no evidence to support the use of the cannnabis product.  

 

Patient Categories

 

Patients are grouped into two categories:

 

• Category A - patients are defined as 'persons who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.' 

 

• Category B - all other patients that do not fit the Category A definition, or terminally ill patients requiring Schedule 9 cannabis.

 

SAS Category A - Determined by the presriber - Notification only 

 

Apart from Schedule 9 cannabis, medical practitioners can treat their terminally ill patients with potentially any "unapproved"  Schedule 4 or Schedule 8 cannabis product without requiring the approval of the TGA, as long as the medical practitioner notifies the TGA within 28 days by using a Category A form.  Schedule 9 cannabis is not available under Category A notification only - doctors must apply for approval under Category B. If there is no supply available in Australia, the doctor or a pharmacist may apply to the TGA for an import licence and permit (SAS).  You can read more about the SAS Category A here.

 

 

 

SAS Category B - TGA Treatment approval required  

 

Approval can be given by the TGA or an external delegate, to registered doctors to treat a patient on a case-by-case basis to reflect the individual needs of different patients.

 

Medical practitioners can apply for approval to treat their patient with potentially any "unapproved" cannabis, cannabis resin and cannabinoid product including oils, tinctures, capsules, patches and dried botanical cannabis bud from Australian or overseas suppliers.  

 

Category B Application Process

 

Applications are made to the TGA by registered medical practitioners, preferably the patient's treating doctor, who is best placed to determine the individual needs of the patient, including whether or not treatment with a particular product is required. Wherever possible, applications should be made in writing (preferably on a Category B form or an appropriate format that contains the same information). You can read more about the SAS Category B here.

 

 

 

Importing cannabis from overseas

 

If there is no supply in Australia, either the doctor or a pharmacist can complete a separate application form for an import licence/permit (SAS only).  You can read more about importing cannabis (SAS only) here.

 

 

 

 

State/Territory Approval

 

TGA approval does not override any State/Territory requirements that need to be met before the product can be lawfully supplied within each State/Territory jurisdiction.  State/Territory requirements can be product specific.

 

Please check with your state/territory health department before making an application as each state and territory have different laws on the use of scheduled medicines and cannabis will be no different.

 

Schedule 4 - In June 2015 the TGA Scheduled CBD (THC and other cannabinoid content 2% or less) in the SUSMP as a Schedule 4 prescription medicine.  State approval should not not be required for Schedule 4 CBD cannabis products that fit this criteria.

 

State Approval - Queensland Only

 

Schedule 8 - In November 2015 nabiximols ie: Sativex was included in the Health (Drugs and Poisons) Regulations.

 

This means that doctors can now prescribe and supply Schedule 8 nabiximols such as Sativex (an oral spray), however it must be prescribed by a neurologist or rehabilitation specialist. As there is no local supplier it needs to be imported.

 

Schedule 9 - In December 2015 the Premier and Cabinet made further changes to the Health (Drugs and Poisons Regulation) 1996 to allow access to Schedule 9 cannabis.  

 

These changes mean that Queensland. doctors can now prescribe and supply potentially any form or type of Schedule 9 cannabis products via the SAS regardless of the patient's age or medical condition.

 

Please Note: New form available for Queensland pharmacists applying for state approval to obtain, possess and dispense cannabis.

 

The changes to the Health regulations also allow research trials to be conducted in Queensland using Schedule 9 cannabis.

 

You can read more about State approval here (Queensland only).

 

 

 

 

Costs

 

All costs of SAS cannabis medicines are at the patient's expense. Prescriptions supplied under the SAS are considered to be private prescriptions and cannot count towards your Safety Net threshold.

 

Therapeutic Goods Administration: information and forms  

 

View: Special Access Scheme Forms 

 

View: Supply of unapproved therapeutic goods under the Special Access

 

VIew: Guide to Access to unpproved medicines - Special Access Scheme

 

For further Information about the SAS please visit their website or contact the TGA on the numbers below:

 

• 1800 020 653 

• +61 2 6232 8644

​

ALSO IN THIS SECTION - MCAG REFERENCE GUIDE

 

The Medical Cananbis Advisory Group has put together information and a reference guide to the SAS and Personal Importation Scheme, with links to application forms and other sources of information to assist doctors, pharmacists, patients and carers and other stakeholders who may be interested in using medical cannabis. Please clink on the links below for further information on the SAS and Personal importation. 

 

View: Category A - Determined by the prescriber - TGA Notification Only 

 

Information and application forms for doctors applying to treat patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment. Prescribers can determine to treat their patient with Schedule 4 or Schedule 8 cannabis products without obtaining TGA approval.  Schedule 9 cannabis cannot be precribed under the Category A notification only - doctors must apply to the TGA for treatment approval under Category B.

 

View: Category B Patients - TGA Treatment Approval Required  

 

Category B is for all other patients that do not fit the Category A definition and for terminally ill patients requiring Schedule 9 cannabis.

 

View: Importing cannabis from overseas (SAS Category A and Category B only)

 

Information about applying for an import licence/permit to import cannabis from overseas licenced suppliers. 

 

View: State Approval

 

Information about state/territory approval in general, and application forms and process specific to Queensland doctors and pharmacists. 

 

VIew: Personal Importation Scheme

 

Information for patients travelling back into Australia and bringing "unapproved" Schedule 4 and 8 cannabis products on their person without the need for Special Access Scheme approval or an import permit/licence as long as the person has a valid prescription from his or her doctor.  

 

View: SAS Frequently Asked Questions

 

Provides brief answers to FAQ about the accessing "unapproved" cannabis products through the TGA.

 

View: SAS Flowchart 

 

Disclaimer:  The information contained on this website and links to other resources is for educational purposes only and is not intended as medical or legal advice. Please do your own research and also contact the Therapeutic Goods Administration, your state/territory health department or consult with your doctor or lawyer.