Special Access Scheme: frequently asked questions

9 January 2018

The Special Access Scheme (SAS) refers to arrangements which provide for the importation and/or supply of an unapproved therapeutic good (i.e. those not included on the Australian Register of Therapeutic Goods (ARTG)) for a single patient, on a case-by-case basis.

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Consumers

An application or notification form must be completed by an appropriate health practitioner as they must be able to justify on medical grounds why their patient requires the unapproved therapeutic good.

The prescribing health practitioner (e.g., doctor) is best placed to determine the needs of the patient, including whether or not treatment with a particular unapproved therapeutic good is required. It is expected that, in accordance with good medical practice, a prescribing health practitioner will educate themselves with all available relevant information relating to an unapproved therapeutic good before using it.

It is also important to note that a prescribing health practitioner has the right to decline to prescribe an unapproved therapeutic good if they believe there is either insufficient clinical justification or no evidence to support the use of that particular product.

There is no cost associated with applications or notifications to TGA to access or supply unapproved therapeutic goods through the SAS.

The monetary cost of a therapeutic good is set by the sponsor of the goods and/or the pharmacy through which the goods are accessed (if applicable). Unapproved therapeutic goods are also not eligible to be subsidised under the Pharmaceutical Benefits Scheme (PBS). The TGA does not consider the monetary cost of the goods when making a decision under the SAS.

In some circumstances, a sponsor of a therapeutic good may choose to provide the good on a 'compassionate basis' (compassionate supply). In these scenarios the product may attract no fee or be available at a reduced cost to the patient. Please note, this decision is made at the discretion of the sponsor.

Applications which give monetary reasons as a means of supporting the application will not be considered. The applicant must provide a clinical justification for the therapeutic good and its use, including reasons why the ARTG registered product available in Australia is not appropriate for their patient

In certain circumstances, patients may wish to use the Personal Importation Scheme to import medicines from overseas.

Health practitioners

  • Category A is a notification pathway which can be accessed by a prescribing medical practitioner or a health practitioner on behalf of a prescribing medical practitioner for 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.
  • Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition and where the unapproved good is not deemed to have an established history of use and cannot therefore be accessed through Category C. An approval letter from TGA is required before the good may be accessed. Approvals for medicines accessed through this pathway are typically only issued to medical and dental practitioners.
  • Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use will be specified in a list along with their indications and the type of health practitioner authorised to supply these products for their respective indications. There is a separate list for medicines, medical devices and biologicals.

The TGA has developed an interactive decision tool to assist health practitioners to determine the most appropriate pathway (if any) to access an unapproved therapeutic good.

For the SAS Category A and B there is no 'list' of products available. Any unapproved therapeutic good can potentially be supplied through these two schemes with one exception for SAS Category A. SAS Category A 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 products under this access pathway.These lists can be found in the following legislative instruments:

Applications and notifications made under the SAS pathways are completed and submitted by registered health practitioners, preferably the prescribing health practitioner, who is best placed to determine the needs of the patient, including whether or not treatment with a particular product is required. It is expected that, in accordance with good medical practice, a health practitioner will educate themselves with all relevant and available information about a therapeutic good before using it.

If a patient asks to be treated with a particular unapproved therapeutic good, a health practitioner has the right to refuse to apply to obtain the product if they believe there is either insufficient clinical justification or evidence to support the use of the therapeutic good.

The prescribing health practitioner or another health practitioner acting on their behalf (e.g. a pharmacist) can supply therapeutic goods to seriously ill patients who meet the Category A definition, without the approval of the TGA as long as the health practitioner provides the TGA with a completed Category A notification form. A copy of the completed Category A form must be sent to TGA within 28 days of the medicine or biological being given to the person or within 28 days after the use of the exempt medical device.

The SAS Category A is a notification pathway only, and as such, the TGA does not send out a letter of approval or acknowledgment on receipt of the completed notification form.

The health practitioner is also required to send a copy of the completed Category A form to the supplier of the therapeutic good. This provides the supplier with the legal authority to supply the therapeutic good.

The prescribing health practitioner or someone acting on their behalf can submit an application to the TGA to gain access to an unapproved therapeutic good for a patient that does not fit the Category A definition. Approval of an application to supply a product is required from a delegate in the TGA. Approval by the TGA is given on a patient-by-patient basis to reflect the needs of different patients. Applications can be made by lodging a completed Category B application form with the TGA).

Further information on the application process can be found in the Special Access Scheme Guidance for health practitioners and sponsors.

For commonly requested products, the timeframe between receipt of an application by the TGA until provision of a response to the applicant, is typically 2 to 3 working days. Applications for products not previously requested under the SAS may take longer.

If there is an urgent medical need for access to a therapeutic good, on the top of your application please write: 'URGENT’.

For a limited number of products a phone approval can be given where there is an urgent medical need. This provision is generally only available during advertised TGA shut down periods (e.g. the Christmas holiday period)

The prescribing health practitioner or a health practitioner (eg. Pharmacist) acting on their behalf needs to complete and submit the SAS Category C form following the supply of the unapproved therapeutic good via the SAS Category C pathway. The form does not need to be completed before the good is supplied and is not required to supply the good.

The reason this pathway is referred to as a notification pathway is that health practitioners supplying the unapproved therapeutic good are required to notify the TGA within 28 days of supplying the good.

On our website, the TGA has made available a notification form that health practitioners must complete and provide within this specified period.

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 products from the Category C legislative instruments as appropriate. For example, if TGA believed there were significant safety concerns with a therapeutic good it may be removed from the instrument and any further supply of the product would need approval via the existing Category B pathway.

To keep informed of any updates relating to the SAS or the products available under the SAS Category C notification pathway, please subscribe to TGA's new SAS and AP email subscriber list.

The SAS Category A notification form is valid indefinitely 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 a delegate in the TGA. Category B approvals remain valid as long as the conditions of approval are upheld.

The SAS Category C notification form is also valid indefinitely, unless the substance is captured by the Customs (Prohibited Imports) Regulations 1956. For medicines containing substances captured by the Customs (Prohibited Imports) Regulations 1956, a new Category C notification form will need to be submitted if further quantities are required.

It is preferred that forms are sent via email, as single attachments, to SAS@health.gov.au. If you do not have access to email, you may fax the form to 02 6232 8112. Posting of the hardcopies is not required.

If you have filled out the application incorrectly or require an amendment to an existing application or approval letter, the applicant should contact SAS@health.gov.au or phone 02 6232 8111 to discuss.

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.

Please note that a copy of the form should be kept by the applicant prior to submitting the form to the TGA.

Sponsors are under no obligation to supply an unapproved therapeutic good merely because the TGA has given an approval or authority to supply the product. 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 product.

In addition, TGA approval does not override any State or Territory requirements that need to be met before the product can be supplied lawfully. These requirements can be product specific and applicants need to check these with their State/Territory health department.

The TGA does not supply any therapeutic goods.

If the product 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 will require authorisation to release the product. In the case of supply for a Category A patient, the completed Category A form acts as the authorisation. 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 a product in the legislative instruments acts as the authorisation:

A completed notification form is not required to authorise supply of products through SAS Category C, however a completed notification form must be submitted to the TGA no later than 28 days after the product has been supplied.

If the product is not available from an Australian sponsor, the requesting health practitioner will need to find an overseas source. The product 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 medicine, 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 product 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

Sponsors

Item 3 of Schedule 5 of the Therapeutic Goods Regulations 1990states that the following goods are exempt from Part 3-2 of the Act:

Samples of therapeutic goods imported, exported, manufactured, or supplied for:

  1. submission to a regulatory authority; or
  2. subjection to developmental or quality control procedures; or
  3. examination, demonstration or display; or
  4. subjection to analysis or laboratory testing procedures;
  5. but not for supply for therapeutic use in humans.

Therefore, if importing therapeutic goods for research purposes only (not for supply for therapeutic use in humans), SAS exemption is not required.

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.

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.

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.

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.

To keep informed of any updates relating to the products available under the SAS Category C notification pathway, please subscribe to TGA's new SAS and AP email subscriber list.