{"id":"F2009L04197","name":"Therapeutic Goods (Listing) Notice 2009 (No. 7)","slug":"therapeutic-goods-listing-notice-2009-no-7","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":81872,"registerId":"commonwealth-F2009L04197-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2009 (No. 7)","content":"![](image.001.png)\n\nTherapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2009 (No. 7)\n\nI, CHARLES MASKELL-KNIGHT, Acting National Manager, Therapeutic Goods Administration, delegate of the Minister for Health and Ageing for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods (the ARTG) for listed goods:\n\n-   preparations, for the purpose of Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘Terminalia bellirica’ as a therapeutically active ingredient, subject to the following conditions:\n\n\\- the ingredient consists of aqueous extract of the fruit pericarp (all fruit tissue without the seeds) only; and\n\n\\- the ingredient is included in medicines for oral administration only.\n\nThis Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.\n\nPursuant to subsection 9A(6) of the Act this Notice ceases to have effect on the day that amendments to the Regulations come into effect to require inclusion of the therapeutic goods listed in this Notice in the part of the ARTG for listed goods.\n\nDated this 10th day of November 2009\n\n(as signed by)\n\nCharles Maskell-Knight\n\nDelegate of the Minister for Health and Ageing","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1339},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The notice serves its original purpose of temporarily listing specific therapeutic goods in the Australian Register of Therapeutic Goods pending permanent regulatory amendment, exactly as authorized by section 9A(5) of the Therapeutic Goods Act 1989."},"complexity_factors":["Single operative provision with only two specific conditions","No defined terms or interpretation section","Clear commencement and automatic cessation provisions (sunset clause)","Minimal cross-referencing (only to enabling Act and Regulations)"],"plain_english_summary":"**What this does:** This notice allows herbal medicines containing *Terminalia bellirica* (a plant also known as bibhitaki, used in traditional Ayurvedic medicine) to be sold in Australia as \"listed\" medicines without individual pre-approval assessment.\n\n**Who it affects:**\n- **Manufacturers and importers** of complementary medicines containing this ingredient\n- **Consumers** purchasing herbal supplements containing *Terminalia bellirica*\n\n**Key restrictions:**\n- The ingredient must be a **water-based extract** of the fruit skin only (not the seeds)\n- The medicine must be for **swallowing/oral use only** (not creams, injections, etc.)\n\n**Why it matters:** Normally, ingredients not already approved require extensive safety data. This notice creates a temporary legal pathway for these specific products to be sold immediately, provided they meet the safety conditions above. It remains in force only until permanent regulations are made to cover this ingredient."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2009-no-7","history":"/api/acts/therapeutic-goods-listing-notice-2009-no-7/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2009-no-7/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2009-no-7/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2009-no-7/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2009-no-7/documents"}}