Access to unapproved therapeutic goods for individual patients (Special Access Scheme)

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.

Reusable medical devices are medical devices that are intended by the manufacturer to be used more than once on the same, or multiple patients. Examples of reusable medical devices include medical imaging devices or active devices that administer energy. Like all therapeutic goods, the TGA encourages the use of reusable medical devices that are included in the ARTG.

However, there are times where it may be necessary to use a reusable medical device that is not included in the ARTG in the treatment of patients. Which pathway (if any) a health practitioner should use to access the reusable medical device will depend on the circumstances.

Using a reusable device in the treatment of multiple patients

If you wish to use a device in the treatment of more than one patient, then TGA recommends considering the Authorised Prescriber (AP) pathway or clinical trial pathway. These pathways mitigate potential risks associated with the use of an ‘unapproved’ medical device for multiple patients due to the oversight of a human research ethics committee (HREC) and through reporting obligations. More information about these pathways is available at Unapproved therapeutic goods.

Generally speaking, the SAS B pathway is considered an inappropriate pathway for dealing with reusable devices. This is because the intention of the SAS B pathway is to provide specific approvals on a case-by-case basis. If the unapproved device is intended to be used in the treatment of multiple patients, then the AP or clinical trials pathways are considered to be the appropriate routes of legal supply.

Using a reusable device in the treatment of one patient

If you wish to use an unapproved device in the treatment of only one of your patients, the SAS B pathway can be considered. If you apply for SAS B approval, the TGA delegate considering your application will generally consider patient, practitioner, device and health system factors. In the case of reusable devices, they may also consider, amongst other things, the potential risks associated with their repeat use and the vulnerabilities of the patient in whom it is expected to be used.

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.

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 until the expected duration of treatment lapses, if 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 indefinitely if supply of the unapproved therapeutic good continues to meet the conditions specified in the SAS Category C list unless:

• the item is removed from the SAS C list.
• the notification relates to Schedule 3 nicotine vaping products which require a new notification for each supply.
• the product is subject to Customs (Prohibited Imports) Regulations 1956. A new Category C notification form will need to be submitted if further quantities are required.

The ‘expected duration of treatment’ field completed during SAS C submission does not affect validity of the notification.

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.

Only the named practitioner on the TGA approval letter or notification form is authorised to access the unapproved therapeutic good.

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