Unapproved products for individual patients (Special Access Scheme)
You can apply to access unapproved therapeutic goods for individual patients through the Special Access Scheme (SAS).
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How you access an unapproved therapeutic good for an individual patient depends on if the:
- patient is seriously ill (Category A – medical practitioners only)
- unapproved therapeutic good and your practitioner type is on our established history of use list (Category C)
In these cases you can access the unapproved therapeutic good immediately. You must notify us within 28 days.
If you aren't eligible to apply through categories A or C, use the application pathway (Category B). You must apply and wait for approval before prescribing.
If you want to access medicinal cannabis, it is generally faster to do so through the application pathway (Category B).
The prescriber named on the TGA approval letter or notification form is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter or notification form.
To access an unapproved therapeutic good for an individual patient you must use the Special Access Scheme (SAS) and Authorised Prescriber (AP) Online System. You must register an account to do so.
Before you apply
Read about what you need to do before you apply to prescribe an unapproved therapeutic good (health practitioners).
Patient is seriously ill (Category A)
You can access an unapproved therapeutic good for an individual patient who is seriously ill.
You must be a medical practitioner to use Category A.
A health practitioner can submit the form on your behalf. For example, a pharmacist.
Medicines and biologicals
To access medicines or biologicals under Category A, your patient must be
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.
Medical devices
To access medical devices under Category A, your patient must be
seriously ill with a condition that is reasonably likely to lead to the person’s death within less than a year or, without early treatment, to the person’s premature death.
If your patient is not 'seriously ill'
If your patient does not fit the ‘seriously ill’ definition, consider applying under category B or notifying us under category C.
Find out other ways to access unapproved therapeutic goods.
Notify us (Category A)
If your patient is seriously ill, you can access the unapproved therapeutic good immediately.
You must submit a form to notify us within 28 days of use of the unapproved therapeutic good. You can fill in and submit the form in the online system.
The prescriber must be a medical practitioner. A health practitioner such as a pharmacist can submit the form on behalf of the prescriber.
SAS and AP Online System - external site
Unapproved therapeutic good is on our established history of use list (Category C)
We have deemed some unapproved therapeutic goods to have an established history of use.
These goods are recorded in the SAS Category C lists.
You can access unapproved therapeutic goods on the lists.
Whether you can access an unapproved therapeutic good depends on your profession and the patient's medical condition. These requirements are recorded in the list.
Check the list of products with an established history of use
Notify us (Category C)
You can access the unapproved therapeutic good immediately.
You must submit a form to notify us within 28 days of use of the unapproved therapeutic good. You can fill in and submit the form in the online system.
A health practitioner such as a pharmacist can submit the form on behalf of the prescriber.
Application pathway (Category B)
You can apply to access unapproved therapeutic goods through the application pathway (Category B):
You should do this if you can't access the unapproved therapeutic good through categories A or C.
You must apply and wait for an approval letter.
Another health practitioner such as a pharmacist can submit the form on your behalf.
Medical and other health practitioners can apply to access unapproved therapeutic goods through this pathway.
What you can prescribe depends upon your scope of practice, qualifications, condition being treated and state and territory requirements.
If you don't have experience with an unapproved therapeutic good or condition, you must get a letter of support from an appropriate specialist.
Clinical justification
You must provide brief clinical justification that supports the use of the unapproved therapeutic good for the medical condition.
Your brief clinical justification should summarise relevant past treatments and procedures trialled or considered.
You should give reasons why therapeutic goods in the Australian Register of Therapeutic Goods may not be an appropriate treatment.
Summarise the expected clinical benefits versus the potential risks.
How to apply (Category B)
To apply to access an unapproved therapeutic good under Category B, submit the form in the online system.
SAS and AP Online System - external site
Read more about the SAS and AP Online System.
How your application is assessed
Your application will be processed in 2 to 5 days.
It may take longer if we need to ask you for more information.
It will be assessed by an officer of the Therapeutic Goods Administration. The officer will be a registered medical practitioner or pharmacist.
Decisions are made on a case-by-case basis.
Obtain unapproved therapeutic goods
As the prescriber, it is your responsibility to source the unapproved therapeutic good.
You can do this in conjunction with the dispensing pharmacy.
If you can't source an unapproved therapeutic good, contact someone experienced with importing unapproved therapeutic goods. For example:
- a hospital pharmacy
- wholesalers
- sponsors.
We give health practitioners approval to access unapproved therapeutic goods.
The prescriber named on the TGA approval letter or notification form is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter or notification form.
We don't arrange the supply of therapeutic goods.
Frequently asked questions (FAQ)
In general, therapeutic goods used in Australia must be entered in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Therapeutic Goods Administration (TGA).
All other therapeutic goods not included in the ARTG are considered ‘unapproved’ therapeutic goods. Importantly, unapproved medicines have not been assessed by the TGA with regards to safety, quality, and effectiveness.
The TGA has developed an interactive accessing unapproved therapeutic goods tool to assist health practitioners to determine the most appropriate pathway (if any) to access an unapproved therapeutic good.
Potentially any unapproved therapeutic good can be supplied through the SAS Category A and B pathways, with the exception that the SAS Category A pathway cannot be used to access drugs of abuse in Schedule 9 of the Poisons Standard where the manufacture, possession, sale or use is prohibited by State or Territory law.
For SAS Category C, there is a list available that specifies the medicines, biologicals and medical devices, their indications and the type of health practitioner authorised to supply these unapproved therapeutic goods. See the SAS Category C list.
Health practitioners cannot apply to the TGA to have therapeutic goods included or removed from the legislative instruments.
The TGA will regularly review unapproved therapeutic goods and make changes to add or remove unapproved therapeutic goods from the Category C legislative instruments as appropriate. For example, if TGA believed there were significant safety concerns with an unapproved therapeutic good it may be removed from the instrument and any further supply of the unapproved therapeutic good would need approval via the existing Category B pathway.
In order for the Special Access Section to assist with all online system enquiries, please send an email with the below information to SAS.Support@Health.gov.au:
- full first and last name
- AHPRA number
- username
- email address linked to the account
- screenshot of the issue.
The team will review the issue you are having and respond within 3 business days.
The SAS Category A notification will remain valid as long as the patient continues to meet the Category A definition.
The SAS Category B approval is valid for the period of time specified on the approval letter signed by the TGA delegate as long as the conditions of approval are upheld.
The SAS Category C notification will remain valid as long as supply of the unapproved therapeutic good continues to meet the conditions specified in the SAS Category C list, except for therapeutic goods containing substances captured by the Customs (Prohibited Imports) Regulations 1956, which a new Category C notification form will need to be submitted if further quantities are required.
When applying to access an unapproved therapeutic good on behalf of a patient under the SAS Category B pathway, prescribers must provide a clinical justification. The justification should include the seriousness of the patient's condition, consideration for the use of therapeutic goods that are included in the ARTG and the potential risks and benefits of using the proposed unapproved therapeutic good.
The clinical justification may be succinct and should summarise:
- an outline of the patient's symptoms and/or diagnosis
- details of relevant past treatments and procedures trialled or considered, including reasons why therapeutic goods currently included in the ARTG may not be the most appropriate treatment for the individual patient in the particular circumstance
- an appraisal of the expected clinical benefits versus the potential risks of the proposed treatment.
Submissions must be made via the SAS and AP Online System.
Requests for original application forms submitted to TGA will be considered on a case-by-case basis and will only be provided to the health practitioner whose details are provided on the form. Please email sas@health.gov.au with your request.
The prescriber named on the TGA approval letter or notification form is the only practitioner authorised to access the unapproved therapeutic good using the specific approval letter or notification form.
Sponsors are under no obligation to supply an unapproved therapeutic good. Before considering accessing unapproved therapeutic goods or submitting an application to the TGA, health practitioners should check with the sponsor of the goods to confirm that they will supply the unapproved therapeutic good.
In addition, TGA approval does not override any State or Territory requirements for lawful supply of an unapproved therapeutic good. These requirements can be product specific, and may be checked with contacts for state/territory medicines & poisons regulation units.
The TGA does not supply any therapeutic goods.
If the unapproved therapeutic good is available from a supplier in Australia, you should contact the supplier (sponsor) to organise supply. Within an institution such as a hospital, supply of a medicine may be arranged through the pharmacy department. The supplier should ensure the prescriber has met TGA requirements before they release the unapproved therapeutic good.
In the case of supply for a Category A patient, the health practitioner must notify the TGA within 28 days of supply of an unapproved therapeutic good. The Category A notification receipt may act as an authorisation to supply.
For Category B, an approval number is issued by the TGA and will appear in an approval letter sent to the requesting doctor by the TGA.
For Category C, the inclusion of an unapproved therapeutic good in the legislative instruments acts as the authorisation.. See the SAS Category C list.
A completed notification form is not required to authorise supply of unapproved therapeutic goods through SAS Category C, however a completed notification form must be submitted to the TGA no later than 28 days after the unapproved therapeutic good has been supplied.
If the unapproved therapeutic good is not available from an Australian sponsor, the requesting health practitioner will need to find an overseas source. The unapproved therapeutic good will then need to be imported from that supplier. This can be done by the doctor, a pharmacist, hospital, by the patient or by a licensed importer. When seeking to arrange importation of an unapproved therapeutic good, it is important to check whether it is controlled under Customs (Prohibited Import) Regulations, in which case it cannot be imported without an import permit. A full list of controlled substances is available on the Office of Drug Control website.
If the unapproved therapeutic good is a prohibited import, a permit or licence (or both) may be required. Permits and licences are administered by the Office of Drug Control. For further information please email dcs@health.gov.au
Contact us
To find out more email sas@health.gov.au
Medicinal cannabis
For questions related to medicinal cannabis email medicinal.cannabis@health.gov.au