Category B Patients - TGA Approval Required

 

An Australian registered medical practitioner would need to apply to the TGA for SAS Category B approval to treat a patient with 'unapproved' cannabis medicines. Category B applications are assessed on a case-by-case basis to reflect the needs of different patients.

 

Applications need to address criteria relating to the patient, the product and the prescriber. 

 

The application should be received from a doctor with qualifications and/or expertise appropriate to the condition being treated and the product being used.  Registered medical practitioners who are preferably the patient’s treating doctor should make the Category B application to the TGA.  

 

Category B Application Form (PDF)

 

 

 

 

Obtaining Supply of Cannabis Products

 

Applicants should first check with the supplier to see if they are prepared to supply the product.

 

Suppliers are under no obligation to supply unapproved products.

 

The sponsor/supplier of the product requires authorisation to release the product to the doctor or a pharmacist.

 

From within Australia

 

The doctor or a community pharmacist can apply for an import licence and permit (SAS only).

 

From within an institution, such as a hosptial the supply of cannabis medicine can usually be arranged by the pharmacy department.

 

Please check with your state or territory health department.

 

A licenced drug importer may also arrange to supply the cannabis product to the doctor, hosptial, pharmacist or patient. 

 

From Overseas

 

 

If the product is not available from an Australian supplier, the patient or doctor will need to find an overseas source.  

 

The product will then need to be imported from that supplier.

 

Import Licence Approval (SAS) 

 

A licence and permission to import under the Customs (Prohibited Imports) Regulations 1956 is required if the cannabis is to be imported from overseas. 

 

The TGA will not issue import permits to individuals. Instead, TGA requires applications to be made in writing by the individual's supervising physician or apharamcist under the Special Access Scheme.

 

Additional restrictions on the importation of plant material may be imposed through the Quarantine Act 1908.

 

See the links below for further information about importing cannabis into Australia through the Special Access Scheme and the Personal Importation Scheme.

 

 

 

State/Territory Approval

 

The SAS does not override any State/Territory laws and requirements that need to be met under State and Territory laws.

 

State/Territory requirements can be product specific. Applicants need to check with their State/Territory health department.

 

 

 

Costs

 

The applicant should also check what costs may be involved especially if the product needs to be imported from overseas. There may be costs involved for the purchase of the cannabis as well as costs for telephone calls, facsimiles, postage and handling, shipping and delivery fees. There may also be costs involved with import/export licence and other Customs fees.​

 

Generally, the Commonwealth does not subsidise (through Pharmaceutical Benefits Scheme) the cost of "unapproved" products.  

 

For more information contact the Pharmaceutical Benefits Scheme Telephone Information Line 1800 020 613. 

 

TGA information and forms  

 

Special Access Scheme Forms 

 

Supply of unapproved therapeutic goods under the Special Access

 

Guide to Access to unpproved medicines - Special Access Scheme

 

For further Information about the SAS please contact the TGA or visit their website.

 

• 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: 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.