{"id":"F2008L00384","name":"Therapeutic Goods (Listing) Notice 2008 (No. 1)","slug":"therapeutic-goods-listing-notice-2008-no-1","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":72617,"registerId":"commonwealth-F2008L00384-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2008 (No. 1)","content":"![](image.001.png)\n\nTherapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2008 (No. 1)\n\nI, ROHAN HAMMETT, National Manager, Therapeutic Goods Administration, and the 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 (ARTG) for listed goods:\n\n-   preparations, referred to in Item 3, Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990, for oral use that contain, in combination with at least one other therapeutically active ingredient referred to in Item 3, sodium fluoride, being a substance that is to be mentioned in Part 3 of Schedule 4 of the Therapeutic Goods Regulations 1990, and which comply with the following requirements:\n\n\\- the concentration of fluoride is not more than 1,000 mg/kg; and\n\n\\- the substance is for use only in pastes, powders or gels for dental hygiene; and\n\n\\- claims in relation to fluoride content are restricted to those relating to improvements in dental hygiene or the use of fluoride for the prevention of tooth decay.\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 Therapeutic Goods Regulations 1990 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 4th day of February 2008\n\nDr Rohan Hammett\n\nDelegate of the Minister for Health and Ageing","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":915},"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The notice maintains its original narrow scope: temporarily listing specific fluoride dental preparations pending regulatory amendment. No scope creep detected."},"complexity_factors":["References to external legislative provisions (Therapeutic Goods Act 1989 subsection 9A(5) and Therapeutic Goods Regulations 1990 Schedule 4)","Cross-referencing between the Act, Regulations, and this Notice","Multiple cumulative conditions for eligibility (combination requirement, concentration limit, form restriction, claim restriction)","Temporary/sunset clause mechanism (ceases when Regulations amended)","Specific chemical concentration threshold (1,000 mg/kg)"],"plain_english_summary":"This notice temporarily permits certain sodium-fluoride-containing toothpastes, powders, and gels (≤1,000 mg/kg, for dental hygiene only) to be listed on the Australian Register of Therapeutic Goods as lower‑risk “listed” products, so they can be sold without full medicine registration. Products may only claim dental hygiene or cavity prevention. The change is a temporary measure until permanent regulatory amendments take effect."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2008-no-1","history":"/api/acts/therapeutic-goods-listing-notice-2008-no-1/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2008-no-1/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2008-no-1/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2008-no-1/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2008-no-1/documents"}}