[Dictionary] Authorised Prescriber (AP) Scheme (TGA, Australia)

The Authorised Prescriber (AP) Scheme is one of two pathways under Australia's Therapeutic Goods Act 1989 (Cth) letting a medical practitioner lawfully supply an unapproved therapeutic good (one not on the Australian Register of Therapeutic Goods for the intended use) outside a formal clinical trial. It applies when a single named practitioner needs standing authority to prescribe that good to an entire class of patients with a defined medical condition under their ongoing care -- as opposed to the Special Access Scheme (SAS), which covers a single patient or a specific small group per request. Becoming an Authorised Prescriber requires endorsement from a Human Research Ethics Committee or relevant specialist college (or, for products with an established history of use, direct TGA application), and carries an ongoing obligation to report patient numbers to the TGA roughly every six months.