Generally, therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG).
This must be done before they can be legally supplied, imported to, or exported from, Australia.
Products not included in the ARTG are referred to as unapproved therapeutic goods.
Unapproved therapeutic goods can be legally supplied in Australia through:
the Special Access Scheme (SAS)
the Authorised Prescriber (AP) scheme
clinical trials.
Read more about how unapproved therapeutic goods can be supplied through clinical trials.
Individuals can legally import therapeutic goods for personal use, not supply, under the Personal Importation Scheme.
If you supply, import or export a therapeutic good, you are the sponsor for that product. Read more about the role of the sponsor.
Long-term supply
For long-term supply, you should include your therapeutic good in the ARTG.
Read how to include your therapeutic good in the ARTG and other steps to supply a prescription medicine.
SAS and AP schemes
Health practitioners can prescribe unapproved therapeutic goods to patients under the SAS and AP schemes.
As the sponsor, you must keep records relating to the source, and delivery, of unapproved therapeutic goods and ensure the prescriber has met requirements before you release an unapproved therapeutic good.
The requirements prescribers need to meet depend on the scheme or category they wish to supply under.
You aren't obliged to supply an unapproved therapeutic good. You can refuse to supply the unapproved therapeutic good even if a prescriber gives evidence we have approved, authorised or been notified under the SAS or AP schemes.
SAS Category A
A health practitioner must notify the TGA within 28 days of supply of the unapproved therapeutic good to the patient. You may get a completed notification form from the prescribing medical practitioner or a health practitioner acting on their behalf to legally supply a product.
Medicines
A hospital or other healthcare facility can hold unapproved therapeutic goods, on behalf of a sponsor, ahead of any request to prescribe for patients who are seriously ill and could die without treatment.
You don't need to get a completed notification form before supplying unapproved therapeutic goods to a hospital or other healthcare facility for this purpose, but the TGA must be notified within 28 days of a supply to the patient.
Medicinal cannabis
Medicinal cannabis products supplied through SAS Category A must be imported by the medical practitioner on a patient-by-patient basis.
To import medicinal cannabis through SAS Category A, medical practitioners must get a permit from the Office of Drug Control.
Find out more about licences, permits and importing medicinal cannabis products into Australia.
SAS Category B
The prescriber must provide an approval letter from us. You must get this before you supply the unapproved therapeutic good.
SAS Category C
Health practitioners can supply unapproved therapeutic goods deemed to have an established history of use.
Whether they can prescribe an unapproved therapeutic good depends on their profession and the patient's condition. These requirements are recorded in the SAS Category C list.
A health practitioner must notify the TGA within 28 days of supply of the unapproved therapeutic good to the patient. You don't need a completed notification form to supply the unapproved therapeutic good.
AP scheme
The prescriber must provide an approval letter from us. You must get this before you supply the unapproved therapeutic good.
Reporting requirements
You must report the quantity of each unapproved therapeutic good you have supplied under the SAS and AP schemes. You must do this every 6 months.
You don't need to report quantities supplied through clinical trials.
You should report adverse events or defects from the use of unapproved therapeutic goods you’ve supplied.
Report product quantities every 6 months
Your report must include the product's trade name and quantity supplied in Australia.
When to report
You must report for the periods:
- 1 January to 30 June
- 1 July to 31 December.
You must do this within one month of the reporting period ending.
How to report
Fill in the sponsor six monthly reporting form.
To find out more read the step-by-step guide to completing the form.
Report adverse events and therapeutic good defects
You must report any suspected adverse events or defects within 15 days of learning of them.
Report a problem or side effect
Advertising
You can't advertise unapproved therapeutic goods to the public. Advertising prescription-only goods is prohibited.
Read more about advertising to health professionals.
Australian manufacturing requirements
Australian manufacturers of therapeutic goods must be licensed.
Unless exempt, your licence must specifically authorise the manufacture of unapproved therapeutic goods.
Read Australian manufacturing licences and overseas GMP certification.
Find out more about therapeutic goods manufacturing.
Importing
You will need additional licences and permits to import controlled substances.
This includes narcotics, psychotropics and precursor substances.
Read more about importing therapeutic goods.
State and territory requirements
You must comply with state and territory requirements.
This includes for storage, handling and use of scheduled medicines.
To find out more use the contacts for state and territory medicines and poisons regulation units.
Legislation
Find out more about therapeutic goods legislation and legislative instruments.
Get help or advice
For specific advice about your requirements consider regulatory affairs consultants.
For general help you can email sme.assist@tga.gov.au or contact us.
Frequently asked questions (FAQ)
What are my reporting responsibilities as a sponsor of an unapproved therapeutic good?
As a sponsor of an unapproved therapeutic good, you must report to the Therapeutic Goods Administration (TGA) every six months in relation to products that have been supplied under the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme.
To make a report, fill in and submit the sponsor six monthly reporting form.
Reports must be provided by email to sas@health.gov.au for general medicine reports or medicinal.cannabis@health.gov.au for medicinal cannabis reports.
To assist in completing the form, the TGA has developed a step-by-step guide to completing the form.
Can therapeutic goods be brought into Australia for commercial supply under the Special Access Scheme?
The SAS is a mechanism by which individual patients can access an unapproved therapeutic good through their health practitioner. Therapeutic goods intended for commercial supply in Australia are required to undergo an evaluation for quality safety and efficacy prior to being allowed on the market. The various mechanisms for supply of unapproved products are intended to be only temporary measures for supply, pending general marketing approval of the product.
The TGA has a responsibility to encourage at all times the use of approved (evaluated) products in Australian patients.
For the SAS Category C notification pathway, where can sponsors find therapeutic goods deemed to have an established history of use?
The therapeutic goods, indications and health practitioners that are authorised to supply these goods for the particular indication are included in a legislative instrument.
There are separate legislative instruments for medicines, medical devices and biologicals, respectively. These legislative instruments are publically accessible so sponsors can check to see if any of their products are included on them. See the lists at SAS Category C list.
Inclusion of a product in any of these legislative instruments acts as the authorisation to supply.
Sponsors are not legally required to be in receipt of the notification form from an authorised health practitioner before they can supply an unapproved therapeutic good that is included in one of the instruments.
Can sponsors apply to have unapproved therapeutic goods added or removed from the legislative instrument?
Sponsors cannot apply to the TGA to have goods included or removed from the legislative instruments.
The TGA will regularly review unapproved therapeutic goods and make changes to add or remove products as appropriate. For example, if TGA believed there were significant safety concerns with the good it would be removed from the instrument; and any further supply of the product would need approval via the existing Category B (application) pathway.
Is a SAS submission required for 'off-label' use of a therapeutic good?
Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported into, supplied in, and exported from Australia. Therapeutic goods are included in the ARTG with specific indication(s) or intended purpose(s). 'Off-label use' generally refers to the use of a therapeutic good for an indication or intended purpose that is not specified in the ARTG entry.
The TGA is not responsible for regulating health professionals or clinical practice. 'Off-label use' is a clinical decision made at the discretion of the prescriber who is responsible for obtaining informed consent from their patient. Therefore, no exemption, approval or authorisation is required from the TGA to allow the off-label use of a product.
In exceptional circumstances, a Special Access Scheme (SAS) submission may be required for off-label use of a medicine or biological. For example, this may occur in situations where the prescriber has directly contacted the sponsor to request access to the product for their patient through a compassionate supply arrangement. In these circumstances, the sponsor may request an SAS notification or approval to ensure legal supply of the product under the therapeutic goods legislation.
However, the TGA does not have the authority to grant an SAS Category B approval for a medical device included in the ARTG. Therefore, the SAS Category B pathway cannot be used to obtain supply of any medical device included in the ARTG, regardless of the proposed use of the device.