{"id":"F2012L02190","name":"Therapeutic Goods (Listing) Notice 2012 (No. 3)","slug":"therapeutic-goods-listing-notice-2012-no-3","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":90164,"registerId":"commonwealth-F2012L02190-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2012 (No. 3)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2012 (No. 3)\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 ‘ubiquinol-10’ as a therapeutically active ingredient, subject to the following conditions:\n    -   the preparations are for oral use only; and\n\n-   the preparations provide not more than 150 mg ubiquinol-10 per daily dose; and\n-   the container, and any other packaging, for the preparation is labelled with the following warning:\n\n“Not to be taken, if on warfarin therapy, without medical advice”.\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 9th day of November 2012\n\n(Signed by)\n\nDr John Skerritt\n\nDelegate of the Minister for Health","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":2450},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The notice maintains its original narrow scope to temporarily list ubiquinol-10 preparations pending permanent regulatory amendment. It does not expand beyond the specific ingredient and safety conditions originally intended."},"complexity_factors":["Single specific ingredient addressed (ubiquinol-10)","Only three operational conditions (route of administration, dosage limit, labelling requirement)","Automatic sunset clause tied to future regulation amendment","No defined terms or complex nested cross-references"],"plain_english_summary":"Approves ubiquinol‑10 (a form of CoQ10) for legal OTC sale in Australia as a listed medicine, subject to oral use only, a 150 mg/day maximum, and a mandatory \"not to be taken if on warfarin without medical advice\" warning. It lets supplement makers sell and consumers buy this product while highlighting a significant drug‑interaction risk; the approval is temporary."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2012-no-3","history":"/api/acts/therapeutic-goods-listing-notice-2012-no-3/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2012-no-3/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2012-no-3/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2012-no-3/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2012-no-3/documents"}}