Special Access Scheme

About Special Access Scheme therapeutics

Unapproved Therapeutic Goods

Prior to a new medication being available for use in Australia, the Therapeutic Goods Administration (TGA) assesses it for safety, quality and efficacy. Once this assessment is complete and the medication is approved for use, the TGA will include it on the Australian Register of Therapeutic Goods (ARTG). A medicine must be on the ARTG in order for it to be supplied within Australia.

Some medicines are not registered in Australia and are therefore not available for use. Those that are not registered on the ARTG are defined as unapproved therapeutic goods. If specific conditions are met, a health practitioner can prescribe an unapproved therapeutic good for use.

A company that supplies, imports or exports unapproved therapeutic goods are deemed the sponsor of that product. Unapproved therapeutic goods can be legally supplied in Australia through the following pathways:

• Clinical trials;
• The Special Access Scheme (SAS); or
• The Authorised Prescriber (AP) scheme.

What is SAS?

The Special Access Scheme (SAS) enables the prescription of unapproved therapeutic goods on a case-by-case basis by medical and healthcare professionals. The prescription of an unapproved therapeutic good for an individual depends on if the:

• Patient is seriously ill (Category A -medical practitioners only); or
• Product is on the TGA’s established history of use list (Category C)

Both Category A and C can be prescribed immediately but if neither categories are applicable then Category B pathway is used. This requires TGA pre-approval before the product can be supplied in Australia.
Tri-Med has a long history in accessing and importing SAS medications. The Tri-Med team can provide you with professional assistance in the process for supplying unapproved therapeutic goods under the Special Access Scheme.

Tri-Med is able to provide information and supply medicines not on the ARTG that are approved for import and supply in Australia because:

• There is a shortage of a medicine registered in Australia; and
• The medicine is needed in the interest of public health.