{"id":"F2014L01421","name":"Therapeutic Goods (Listing) Notice 2014 (No. 6)","slug":"therapeutic-goods-listing-notice-2014-no-6","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":128682,"registerId":"commonwealth-F2014L01421-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2014 (No. 6)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2014 (No. 6)\n\nI, JOHN SKERRITT, National Manager of the Therapeutic Goods Administration, delegate of the Minister for Health 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 Register) for listed goods:\n\n-   preparations, for the purpose of Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), that contain ‘alfadex’ as a therapeutically active ingredient, subject to the following conditions:\n\n    the preparations are for oral use only; and\n\n    the preparations provide not more than 6 g of alfadex per daily dose; and\n\n    the preparations are presented in a therapeutic dosage form for therapeutic use.\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 Register for listed goods.\n\nDated this 3rd day of October, 2014\n\n(Signed by)\n\nJohn Skerritt\n\nDelegate of the Minister for Health","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1703},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The notice maintains its original narrow, interim purpose. It was explicitly designed as a temporary bridge (ceasing when regulations catch up) to list one specific ingredient with defined constraints, and has not expanded beyond this limited scope."},"complexity_factors":["Single active ingredient specification (alfadex) with only three attached conditions","Brief document with no definitions section or nested procedural requirements","Cross-references to parent legislation (Therapeutic Goods Act 1989, subsections 9A(5) and 9A(6))","Self-terminating mechanism (automatically ceases when Regulations are amended)"],"plain_english_summary":"This notice allows specific supplements containing **alfadex** (alpha-cyclodextrin) to be sold in Australia as \"listed\" therapeutic goods — a category with lower regulatory requirements than registered medicines.\n\nIt applies to oral preparations (like tablets or capsules) that:\n* Contain alfadex as an active ingredient\n* Provide no more than 6 grams per daily dose\n* Are presented in a therapeutic dosage form for therapeutic use\n\n**Who it affects:** Companies making or importing dietary supplements containing alfadex, and consumers who buy them.\n\n**Why it matters:** This acts as a temporary approval pathway, letting these products bypass the usual lengthy registration process until permanent regulations are updated to include them automatically."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2014-no-6","history":"/api/acts/therapeutic-goods-listing-notice-2014-no-6/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2014-no-6/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2014-no-6/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2014-no-6/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2014-no-6/documents"}}