Special Access Scheme: frequently asked questions

7 July 2017

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

No. An application or notification form must be completed by an appropriate health practitioner as they must be able to justify on medical grounds why his/her patient requires the unapproved product.

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

It is also important to note that a treating health practitioner has the right to decline to prescribe an unapproved product if he/she believes there is either insufficient clinical justification or no evidence to support the use of the product.

No. The monetary cost of the goods is set by the sponsor and/or the pharmacy (as applicable). The TGA does not consider the monetary cost of the goods when making a decision under the SAS.

In some circumstances, sponsor may choose to provide the product on a 'compassionate basis' (compassionate supply) where the product may attract no fee or a reduced cost to the patient. This is at the discretion of the sponsor.

No. 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 good and its use which includes 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

Most therapeutic goods are required to undergo an evaluation for quality, safety and efficacy and be included on the ARTG before they can be supplied in Australia.

In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, the TGA manages the SAS and other programs.

Applications under the SAS are made to the TGA by registered health practitioners, preferably the treating medical practitioner (doctor), 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 him/herself with all relevant and available information about any product before using it.

Even if a patient asks to be treated with a particular unapproved product, a health practitioner has the right to refuse to apply to obtain the product if he/she believes there is either insufficient clinical justification or no evidence to support the use of the product.

For SAS Category A and B there is not a 'list' of SAS products. Under these two schemes, any unapproved therapeutic good can potentially be supplied except for 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 separate list specifying the medicines, biologicals and medical devices, their indications and the type of health practitioner authorised to supply these products for their respective indications. These lists can be found in the following legislative instruments:

Before accessing unapproved therapeutic goods through these pathways, applicants should check with the supplier to see if they are prepared to supply the product before making an application.

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.

  • Category A is a notification pathway which can only be accessed by medical practitioners 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.

Medical practitioners can supply goods to very seriously ill patients without the approval of the TGA as long as the medical practitioner provides the TGA with a completed Category A notification. A copy of the completed Category A form must be sent to TGA – for medicines and biologicals: within 28 days of the medicine or biological being given to the person; for medical devices: within 28 days after the use of the exempt device. Category A is a notification only, and as such, the TGA does not send out a letter of approval or acknowledgment.

The medical practitioner also sends a copy of the completed Category A form to the supplier of the product. This provides the supplier with the legal authority to supply the product.

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 should 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.

We suggest you allow an additional 2-5 working days to receive any correspondence sent by post.

If there is an urgent medical need for access to the product the application can be faxed to the TGA. On the bottom of your application please write: 'URGENT: FAX/EMAIL RESPONSE ASAP'.

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).

You need to first check to see if the therapeutic good(s) you want to access are on the legislative instruments. These therapeutic goods may only be accessed through this pathway by a health practitioner authorised to supply the goods for the indication(s) that are included in the instrument.

The legislative instruments for medicines, medical devices and biologicals are:

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.

The pharmacist is very often the health practitioner who supplies the unapproved therapeutic good to the patient and is therefore best placed to determine the date of supply.

A pharmacist can complete and submit the notification form on behalf of the treating health practitioner who is authorised to supply the goods, so long as there are sufficient controls in place to ensure appropriate practitioner oversight in that process.

In this case, the pharmacist is responsible for ensuring that they have a valid order (such as a prescription or medication chart entry) from the treating practitioner for the unapproved good and that they understand the clinical context in which the good will be used in order to confirm that it is being used in accordance with the 'rules'.

The treating health practitioner or someone acting on their behalf (e.g. a pharmacist) needs to complete and submit the SAS Category C form after the unapproved therapeutic good has been supplied through the SAS Category C pathway. The form does not need to be completed before the good is supplied or to trigger the supply of the product.

The health practitioner or someone acting on their behalf (e.g., a pharmacist) needs to submit the notification form to the TGA within 28 days of supplying the good.

The sponsor is not legally required to be in receipt of the notification form before they can supply any of the unapproved therapeutic goods listed on the instruments.

The treating health practitioner (or someone acting on their behalf) should contact the sponsor(s) of products of interest that have been affected by introduction of the SAS Category C pathway to find out more about what processes they have established to enable supply of these products.

Health practitioners 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 pathway.

The TGA has developed an interactive decision tool to assist health practitioners to determine which pathway, if any, is most appropriate to access an unapproved therapeutic good. This tool consists of a series of questions in plain English, such as 'Are you a health practitioner?', and based on the responses to these questions, health practitioners are advised of the most appropriate unapproved therapeutic goods access pathway, with links to further guidance and relevant forms.

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.

Please see Medicinal cannabis - Frequently asked questions.

Requests for original application forms submitted to TGA will be considered on a case-by-case basis and will only be provided to the applicant. 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.

The applicant should contact SAS@health.gov.au or phone 02 6232 8111 to discuss.

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 doctor 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 ODC 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

The TGA does not supply any therapeutic goods.

No. Sponsors are under no obligation to supply an unapproved product merely because the TGA has given an approval or authority to supply the product. Before submitting an application to the TGA or considering accessing unapproved products through SAS Category A or SAS Category C, health practitioners should check with the sponsor to see if they are prepared to supply the product.

In addition, TGA approval does not override any State/Territory 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.

Sponsors

No.

Item 3 of Schedule 5 of the Therapeutic Goods Regulations 1990 states 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.

No. The SAS is a mechanism by which individual named 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 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.

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.

Sponsors need to check the following legislative instruments to see if any of the products they are intending to supply are included:

Inclusion of a product in any of these legislative instruments acts as the authorisation to supply.

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.

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.