Australia TGA Readiness: AUST L, Permitted Indications and PIC/S PE 009 GMP

Section 26A of the Therapeutic Goods Act 1989 creates the Listed Medicines pathway. AUST L is electronic self-listing for low-risk complementary medicines whose ingredients are all on the Therapeutic Goods (Permissible Ingredients) Determination and whose indications are all on the Therapeutic Goods (Permitted Indications) Determination. The sponsor certifies compliance and the ARTG entry is generated immediately — no pre-market efficacy review. AUST L(A) (introduced 2018) is for sponsors who want to make a non-permitted indication and accept TGA assessment of the efficacy evidence. AUST R is full registration with quality, safety and efficacy review — the path for higher-risk products including most herbal medicines with disease-treatment claims. Picking the wrong pathway is the most expensive avoidable error: an AUST L self-listing with a non-permitted indication will be cancelled at TGA compliance review, with the product withdrawn from sale.

The Therapeutic Goods (Permissible Ingredients) Determination is updated annually and lists every active and excipient ingredient that may be used in an AUST L medicine, with conditions (concentration limits, route restrictions, warnings, equivalent-amount rules for botanical extracts). An ingredient not on the Determination cannot be self-listed — the sponsor either applies to add it (typically a multi-year evidence dossier), pursues AUST L(A) or AUST R, or reformulates. The Determination also drives mandatory equivalent-amount labelling for herbal extracts (the dry herb equivalent and the actives), and pegs warning statements via RASML to specific ingredients (e.g., kava, comfrey, ephedra-containing).

The Therapeutic Goods (Permitted Indications) Determination 2018 contains the ~1,000 indications a sponsor may select from for AUST L self-listing. Each is paired with a level of evidence (traditional or scientific) and may carry a mandatory qualifier (e.g., 'traditionally used in Western herbal medicine'). TGA's Post-Market Review programme samples AUST L medicines and verifies the held evidence supports the listed indications. Compliance review findings cluster on three themes: indications not held in the file, evidence weaker than the Determination requires, and label claims drifting beyond the Permitted Indications wording (especially on websites and social, which the TAC and the Therapeutic Goods Advertising Code 2021 explicitly cover). A failed review can trigger cancellation, infringement notice or court action.

Australian manufacturing licences for medicines are issued under section 35 of the Act and require compliance with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-17). For complementary medicines the relevant annexes are typically Annex 7 (herbal medicinal products), Annex 8 (sampling of starting and packaging materials) and Annex 15 (qualification and validation). Overseas manufacturers supplying the Australian market must hold either a TGA GMP Clearance based on a recognised foreign regulator's inspection (under the MRA, MoU or CV pathway) or a TGA-conducted inspection. The hot zones at recent TGA inspections: data integrity in laboratory systems, stability data not bracketing labelled shelf-life, contamination control at the dispense booth for herbal raw materials, and supplier qualification for botanical actives.

Days 1–15: pathway gate — AUST L vs AUST L(A) vs AUST R per SKU, with Permissible Ingredients and Permitted Indications check. Days 16–35: ARTG self-listing for AUST L SKUs, AUST L(A) evidence assembly for those that need it. Days 36–60: RASML and Therapeutic Goods Advertising Code label and marketing-claim review. Days 61–90: PIC/S PE 009 GMP evidence pack — Annex 7 herbal, Annex 8 sampling, Annex 15 validation, plus data-integrity walkthrough. Days 91–110: TGA GMP Clearance or domestic licence amendment. Days 111–120: mock TGA post-market compliance review.