AUST L

AUST L is the identifier prefix the Therapeutic Goods Administration (TGA) assigns to a complementary medicine entered on the Australian Register of Therapeutic Goods (ARTG) via the electronic Listing pathway under section 26A of the Therapeutic Goods Act 1989. The sponsor self-certifies that every ingredient is on the Therapeutic Goods (Permissible Ingredients) Determination and every indication is on the Therapeutic Goods (Permitted Indications) Determination 2018, with any Required Advisory Statements (RASML) on the label. There is no pre-market TGA review of efficacy — the ARTG entry is generated immediately on payment and certification, and post-market compliance review is how the TGA tests whether the certification was honest.

AUST L sits inside a three-pathway scheme. AUST L is low-risk self-listed (Permissible + Permitted only). AUST L(A) (introduced 2018) is for sponsors who want to make a non-permitted indication and submit the supporting efficacy evidence for TGA assessment. AUST R is full Registered Medicine — quality, safety and efficacy review 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avoidable error: an AUST L self-listing carrying a non-permitted indication is cancelled at compliance review and withdrawn from sale.

Manufacturing for any AUST L product must comply with PIC/S Guide to GMP for Medicinal Products PE 009-17 — Australia is a PIC/S member, so AUST L manufacturing GMP is structurally European GMP, with Annex 7 (herbal medicinal products), Annex 8 (sampling of starting and packaging materials) and Annex 15 (qualification and validation) as the typical hot annexes. Overseas manufacturers need a TGA GMP Clearance based on a recognised foreign regulator inspection or a TGA-conducted inspection. In V5 the AUST L number, the Permissible Ingredients certification, the Permitted Indications selection with evidence, the RASML warnings and the PE 009 GMP record all live on one SKU and batch spine, so a TGA post-market compliance review opens to a compiled response rather than a folder hunt.