Queensland: State approval for medical cannabis treatment Special Access Scheme Category B - Schedule 8 and 9 cannabis

 

Queensland State approval application forms for doctors and pharmacists to apply to Queensland Health to prescribe, supply, administer, obtain and dispense Schedule 8 and 9 medical cannabis products are now available. (SAS only).  

 

Note: State approval not required for Schedule 4 CBD.

 

Note: New separate form available for pharmacists to obtain, possess and dispense for download below. 

 

Doctors: State approval to treat patient with medical cannabis

 

• The doctor completes the doctors application form that can be downloaded below in PDF form.  

• The completed application is sent by mail to Queensland Health with a copy of the TGA SAS Category B treatment approval letter with other supporting documents.  

• If the doctor is to dispense and supply the medical cannabis directly to the patient from his or her practice, the doctor will also need to complete the dispensing part of the form.

 

Doctors Application Form (PDF)

 

Conditions

 

• The patient will need to give their full and written informed consent to the doctor, assuming full responsibility for all and any outcomes of using the cannabis as an "unapproved" product.

 

Pharmacists: State approval to obtain, supply and dispense Schedule 8 and 9 medical cannabis

 

• If the medical cannabis is to be dispensed from a community pharmacy, the pharmacist will need to complete the pharmacist application form and send to Queensland Health for approval to obtain, possess and dispense.

• The pharmacist will then need to apply to the TGA for an import licence and permit (SAS) for each product.

 

Pharmacists Application Form (PDF) 

 

• Patients and carers in possession of cannabis will be exempt from being charged under the Drugs Misuse Act, and in the case of parents, carers and other stakeholders, they will be able to lawfully supply and/or administer the cannabis treatment.

 

Applying for an Import Licence (SAS)

 

• The importer, (doctor with Category B treatment approval or a pharmacist) sends the SAS Category B import licence and permit applications (which are separate applications to the SAS treatment approval application), along with the SAS Category B treatment approval letter and State approval letter to the import section of the TGA.

• The import section of the TGA will send the doctor or pharmacist, their import licence and a permit for each product.

•  A copy of the import licence and permit is forwarded to the overseas supplier, with payment of goods if requested.

• If the overseas company already holds an export licence, the goods can be sent by air express to Australia.  Note: Some companies for example in Canada and the Netherlands already hold export licences and should only need to apply for an export permit. 

•  If the company does not hold an export licence they will need to apply for one through their relevant health and/or customs authority.

 

Note: most countries have similar programs to Australia's SAS, which provide for the export of medicines, as well as import. 

 

Supply from within Australia

 

• The State approval letter and SAS  Category B treatment approval letter should act as a supply authority, if the cannabis is available from an Australian company, sponsor, drug importer or hosptial.

 

In some cases, the TGA may allow the import of up to 12 months supply of some "unapproved" cannabis medicines, rather than going through the SAS process each month or quarterly, as this would be too burdensome

 

There may be conditions imposed on the amount of cannabis treatment the pharmacist can dispense to the patient/carer, ie it may need to be collected monthly.

 

There may also be safety/storage/security requirements such as cannabis medicines to be kept in the fridge in a locked safety box with a key, and out of reach of children. 

 

Discrimination

 

Patients who have been prescribed cannabis products via the SAS can lawfully possess these products in Queensland, but will need to check with the relevant health authority in other jurisdictions if travelling interstate or overseas.

 

As the medical cannabis products are legally prescribed and supplied the patient should not be subjected to discrimination in the areas of health, education, employment or travel.

 

Patients/carers should not face discrimination in any of these areas, as cannabis should be treated like any other lawfully prescribed medicine.

 

Other states and territories

Please check with your relevant health authority as each state and territory have different laws on the use of cannabis and scheduled medicines.

 

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: 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.