AUST L / TGA
Australia TGA Listed Medicines · Listed Medicines · Permitted Ingredients · Permitted Indications · AUST L(A) · GMP Clearance · ARTG
Australia therapeutic-goods framework — TGA Listed Medicines AUST L (Permitted Ingredients Determination, Permitted Indications list, sponsor self-certification, days-to-weeks listing) and AUST L(A) Listed Assessed (TGA pre-market efficacy review) with overseas manufacturer GMP Clearance via MRA, CV or inspection pathways.
Australia regulates supplements as therapeutic goods under the TGA, not as a separate food-supplement category. The dominant pathway is Listed Medicines (AUST L) — streamlined risk-based regime requiring all ingredients on the Therapeutic Goods (Permissible Ingredients) Determination (with per-ingredient maximum daily dose, route, dosage form, population and warning conditions), all indications on the Therapeutic Goods (Permissible Indications) Determination (~1,300 permitted indications across structure/function, vitamin/mineral function, Western herbal traditional, TCM, Ayurvedic, aromatherapy, homoeopathic) with verbatim TGA wording, sponsor self-certification, ELF electronic listing, and ARTG listing typically within days/weeks. AUST L(A) Listed Assessed Medicines (introduced 2018) covers intermediate-risk indications outside the Permitted Indications scope, subject to TGA pre-market efficacy assessment of the specific indication. AUST R Registered Medicines is the full pre-market evaluation pathway for higher-risk products. Manufacturing must occur in TGA-licensed facilities under PIC/S GMP — Australian sites hold direct Manufacturing Licences, overseas sites require GMP Clearance via Mutual Recognition Agreement (EU, UK, Switzerland, Canada, US for some categories), Compliance Verification (using overseas regulator inspection reports) or direct TGA inspection pathways. Sponsor (the Australian-resident entity legally responsible) holds non-delegable obligations including annual fee per listing, evidence available on request, Therapeutic Goods Advertising Code compliance, Uniform Recall Procedure readiness and adverse event reporting. TGA post-market compliance review of Listed Medicines is active with historically substantial finding rates driving the importance of pre-market sponsor due diligence and ongoing compliance investment.
- Therapeutic Goods Act 1989
- Therapeutic Goods Regulations 1990
- PIC/S Guide to GMP
- Permitted Ingredients Determination
- Permitted Indications Determination
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