Authorised Prescriber (AP) Scheme (TGA, Australia)

The Authorised Prescriber (AP) Scheme is one of two pathways under Australia’s Therapeutic Goods Act 1989 (Cth) that let a medical practitioner lawfully supply an “unapproved” therapeutic good — a medicine, medical device, or biological not entered on the Australian Register of Therapeutic Goods (ARTG) for the intended use — outside a formal clinical trial. The Therapeutic Goods Administration (TGA) administers it alongside the related Special Access Scheme (SAS), and the two are frequently confused because they solve the same underlying problem — legal access to an unapproved product — through different mechanics.

What distinguishes AP from SAS

The operative difference is scope and duration, not the product itself. SAS is a per-patient or per-defined-group request: a practitioner applies (or, for SAS Category A/C, notifies the TGA) each time, for a specific patient or a specific small group. The AP Scheme instead grants a named practitioner standing authority to prescribe or supply a specified unapproved good to an entire class of patients with a defined medical condition under their ongoing care, without a fresh application for each new patient in that class. For a clinician managing an open-ended cohort rather than one-off cases, AP status removes the administrative overhead of repeated individual SAS applications.

How a practitioner becomes an Authorised Prescriber

Two endorsement pathways lead to AP status:

• Human Research Ethics Committee (HREC) endorsement — for products without an established history of use in the proposed indication, the applicant needs endorsement from an HREC (or, for some applications, a relevant specialist college) before applying to the TGA. This is the pathway that most directly touches research governance infrastructure, since it routes through the same ethics committee apparatus that reviews clinical trials.
• Established history of use — where the product already has a recognised history of safe use for the proposed indication (documented in TGA guidance), the practitioner can apply to the TGA directly without HREC or specialist college endorsement.

Only registered medical practitioners can hold AP status — the scheme does not extend to nurse practitioners or other prescribing health professionals. Applications and the ongoing reporting below are lodged through the TGA’s SAS & AP Online System.

Ongoing obligations once authorised

AP status is not a one-time approval. An authorised prescriber must report to the TGA on the number of patients supplied under that authority, generally every six months, and must report adverse events associated with the product per the TGA’s standard pharmacovigilance requirements. The authority is also personal to the named practitioner — it does not transfer to a colleague covering the same patient cohort, and a practising group intending several clinicians to prescribe under AP status generally needs each of them separately authorised.

Where this intersects clinical research administration

The AP Scheme comes up most often for research offices at the boundary between a clinical trial and standard care — specifically, continued access. When a trial closes to enrolment or reaches its planned endpoint but individual participants are still benefiting from an investigational product with no approved alternative, a sponsor and treating clinicians need a lawful mechanism to keep supplying it. An AP application (rather than a fresh SAS Category B request for every remaining participant) is the standard route when that cohort is more than one or two patients and is expected to continue for some time — it converts what would otherwise be a per-patient administrative burden into a single standing authority covering the whole group. This makes AP status a genuine post-trial-transition tool that research administrators coordinating investigator-initiated or sponsor-led trials need to plan for before a trial’s access arrangements lapse, not after — alongside the broader hospital-level obligations set out in the National Clinical Trials Governance Framework, which governs how accredited health services embed trial-adjacent activity like this into routine care.