Category A: Exemption in Life Threatening Conditions - TGA Notification only
Category A is a notification pathway specifically for patients who are seriously ill with a life threatening condition.
Any registered medical practitioner in Australia may supply a medicinal cannabis product to a patient who meets the Category A definition without the approval of the TGA as long as the medical practitioner notifies the TGA within 28 days of signing the form.
The Category A form acts as an "authority to supply" and provides the sponsor with the legal authority to supply the product. The treating doctor is in effect the approving authority in that he/she is prepared to prescribe the product in question without the need of TGA approval.
Legal Definition - Category A
A Category A patient is legally defined in the Therapeutic Goods Regulation 1990 as:
"a person who is 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."
NOTE: It is up to the individual medical practitioner to assess their patient and determine whether the patient fits the legal criteria for notification under Category A.
Please also note the OR in the definition of Category A patient. The phrase terminal is not used. Category A is not restriced to patients with a terminal illness.
"a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months,
OR
a person who is seriously ill with a condition from which premature death is reasonably likely to occur in the absence of early treatment."
Patients cannot apply for access to unapproved therapeutic goods through the SAS. Patients need to consult with their medical practitioner about the suitability of using an unapproved medicinal cannabis product and applying for access via the SAS on your behalf.
Access to potentially any cannabis product execept Schedule 9
Patients with life threatening conditions can potentially access any unregistered medicine including cannabis products through the Category A notification pathway except for those medicines listed in Schedule 9 of the SUSMP.
In November 2016 the TGA downscheduled cannabis and tetrahydrocannabinols to Schedule 8.
In 2015 CBD was scheduled as a Schedule 4 prescription medicine.
Types of cannabis products patients can access includes oils, tinctures, capsules, patches and dried bud.
The product must be legally produced, either in Australia or overseas and manufactured using appropriate manufacturing quality standards.
Prior to notification the patient and doctor should check with the sponsor/supplier to ensure that they are prepared to supply the product. Australian and overseas sponsors are under no obligation to supply unapproved product/s via the SAS.
Notification Form and Process
The Category A Form requires the medical practitioner to certify that he/she:
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has formed the view that the patient is Category A; and
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has obtained the informed consent of the patient, or patient's guardian or legal representative to the product being given to the patient. Informed consent is defined in the regulations to mean consent freely given on the basis of information concerning the potential risks and benefits of the treatment that is sufficient information to allow an informed decision whether to consent to the treatment. Consent should be normally gained in writing unless there are good reasons to the contrary; and
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will prescribe the product in accordance with good medical practice
The medical practitioner must send a copy of the completed Category A Form to the TGA within 28 days of the date of signature on the Form.
Doctors can email the completed Category A to medicinal.cannabis@health.gov.au (this link sends e-mail).
Failure to do so is an offence that carries a financial penalty.
The TGA does not send out a letter of approval or acknowledgment to the doctor.
The TGA may request the doctor to provide further information about the notification to ensure compliance with the scheme.
You can download the Category A form from the TGA website here.
Sponsor and Product Information
The doctor must identify on the Category A form a specific cannabis product/s from a sponsor who is able to legally import and/or supply the cannabis product in Australia. The sponsor should provide the doctor with all of the required information on the proposed product as follows:
Trade name: The brand name of the product as displayed on the product label.
Active ingredient(s) and concentration or proportion of active ingredient(s): The name, strength and/or concentration of each active ingredient in the finished product.
Dosage form: The pharmaceutical form in which a product is presented for therapeutic administration, for example tablet, capsule, liquid oil.
Name of the sponsor: The name of the sponsor of the good.
Schedule of the cannabis product: See Scheduling of medicinal cannabis products
Route of administration: Route by which the medicinal cannabis product will be applied on or introduced into the body, for example oral, inhalation or topical.
Declaration of conformity with the Standard for Medicinal Cannabis (TGO 93): The manufacturer is required to complete a declaration form declaring that the product(s) to be accessed conform to the Standard for Medicinal Cannabis (TGO No. 93) and provide this to the medical practitioner to submit to the TGA. The sponsor is responsible for ensuring compliance with these standards. For more information on Standard for Medicinal Cannabis (TGO No. 93).
Ancillary dosing aids (if applicable): Details of any supplementary device/s which may be needed to allow the dose to be appropriately administered, for example syringes, inhalation or vaporising devices.
For products intended to be administered via the inhalation route, the TGA expects the applicant to provide evidence demonstrating that the delivered dose can be reproducibly delivered to the patient and that the temperature applied to the cannabis is high enough to allow for active cannabinoid vapors to form, but below the point of combustion where smoke and associated toxins are produced.
State/Territory approval
The SAS does not override any State/Territory laws and requirements that need to be met.
State/Territory requirements can be prescriber, condition and/or product specific. Doctors and phamacists should contact their State/Territory health department for any relevant state/territory requirements that need to be met.
Read more about state approval on our website here.
Obtaining Supply via Category A
The patient and doctor should always check with the sponsor/supplier to ensure that they are prepared to supply the product and that the product being sourced is suitable to treat the patient's condition. Australian and overseas sponsors/suppliers are under no obligation to supply unapproved product/s via the SAS.
Note: Supply from within Australia is not currently availabe for Category A notifications
There are no locally made products available however there are a number of importers licensed under the Regulation 5 of the Customs (Prohibited Imports) Regulations 1956 to import bulk supplies of a range of un-registered medicinal cannabis products in accordance with the Therapeutic Goods Act 1989 HOWEVER because of LNP Government policy these pre-imported products can only be supplied if the doctor has a Category B approval letter from the TGA or if they are supplied through a TGA approved authorised prescriber.
The LNP policy behind the Narcotic Drugs Amendment Bill 2016 that was passed by the Australian Parliament in February 2016 to establish a cultivation and manufacturing and supply framework in Australia did not provide for supply upon Category A notification. The Bill only provided for supply through registered products, research trials, Category B of the SAS or through an authorised prescriber. The Bill only applies to locally cultivated and manufactured products and not to imported products through long standing provisions under the Therapeutic Goods Act and Regulations. Please see below for details on importing cannabis.
The Australian Greens have stated they they will introduce a Bill in late 2017 that will amend the Narcotic Drugs Act to allow access to Australian cultivated and manufactured cannabis products but these are not expected to be available until 2018.
When locally made products are available the Category A form will act as an "Authority to Supply" and will be able to be sent direct to the sponsor/supplier as long as state/territory health authority state/territory requirements have been met. See below if products need to be imported.
Importing Cannabis Products - Category A
Until the LNP Government changes their current policy on pre-imported products or supply is available from within Australlia, patients eligible for Category A access will need to find an overseas supplier and have their cannabis imported.
The patient's doctor or a community or hospital pharmacy can apply to the Office of Drug Control for an import licence and import the cannabis product/s for the patient on a case by case basis.
The import licence application form must include the completed Category A notification form and confirmation of state approval if required.
The ODC import licence/permit application form can be downloaded here.
Please also see the links below for further information about importing cannabis products (SAS Category A and B only).
Legislation: Therapeutic Goods Regulation 1990
The Commonwealth Therapeutic Goods Regulation 1990 provides an exemption for patient access to all unapproved medicines in life threatening cases except medicines listed in Schedule 9 as follows:-
12A Unapproved medicines and biological—exemption in life‑threatening cases
(1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in the 9th Schedule to the Poisons Standard, as in force from time to time, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).
(1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.
(2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:
(a) the medicine or biological is to be given to a person who satisfies the following criteria:
(i) the person is a Category A patient (as defined in subregulation (5); and
(ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and
(iii) the medical practitioner by whom, or at whose direction, the medicine or biological is to be given to the person has signed a statement in relation to the person in the form approved by the Secretary for the purposes of this paragraph; and
(b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.
(3) A person who signs a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological to be given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.
Penalty: 10 penalty units.
(3A) An offence under subregulation (3) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
(4) This regulation does not affect the operation of regulation 12.
(5) In this regulation:
Category A patient means a person who is 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.
informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.
TGA information and forms
For more information on how to access medicinal cannabis products through the Special Access Scheme please visit the TGA website at the links below.
Access to Medicinal Cannabis products: General Information
Access to Medicinal Cannabis products: Steps to Using Access Schemes
Flowchart: Steps to Using Access Schemes
TGA Standard for Medicinal Cannabis (TGO No. 93)
Supply of Unapproved Therapeutic Goods under the Special Access
Comprehensive Guide: Access to Unpproved Medicines - Special Access Scheme
Special Access Scheme: General guidance for health practitioners and sponsors
Contact numbers for the TGA:
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1800 020 653
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+61 2 6232 8644​
Office of Drug Control - Importing Cannabis (SAS Only) Medical Practitioner or Pharmacist use only
Importing medicinal cannabis products SAS
Import licence application form (SAS only)
ALSO IN THIS SECTION
Please clink on the links below for further information on the SAS and Personal importation.
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 products (SAS Category A and Category B only)
Information about applying to the Office of Drug Control for an import licence/permit to import cannabis products from overseas suppliers.
View: State Approval
General information about state/territory requirements and processes 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.
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 consult with your doctor and a lawyer if needed. Please also contact the Therapeutic Goods Administration and your state/territory health department for information about Commonwealth and state/territory requirements that must be met.