{"id":"F2013L00015","name":"Therapeutic Goods (Listing) Notice 2012 (No. 5)","slug":"therapeutic-goods-listing-notice-2012-no-5","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":126818,"registerId":"commonwealth-F2013L00015-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2012 (No. 5)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2012 (No. 5)\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 ‘caffeine’ as a therapeutically active ingredient, subject to the following conditions:\n\n-   the preparations are for oral use only; and\n\n-   the preparations contain not more than 100 mg of the active ingredient, caffeine, per daily dose; and\n-   the preparations are for use in adults only; and\n-   the preparations must consist principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations 1990.\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 18th day of December 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":2471},"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This notice operates within its intended scope as a temporary listing instrument under section 9A of the Act, providing interim authorization for specific low-dose caffeine preparations pending formal amendment of the Regulations."},"complexity_factors":["Multiple cross-references to parent legislation (Therapeutic Goods Act 1989 subsections 9A(5) and 9A(6), and Therapeutic Goods Regulations 1990 Schedule 4 and Schedule 14)","Four cumulative conditions that must all be satisfied for a product to qualify","Sunset clause triggering automatic cessation upon future amendment of the Regulations","Requires understanding of the distinction between 'listed' and 'registered' therapeutic goods under Australian law"],"plain_english_summary":"This rule lets certain oral caffeine preparations for adults (no more than 100 mg caffeine per day and containing other specified medicinal ingredients) be added to the Australian Register of Therapeutic Goods through the simpler listing pathway instead of full registration. It streamlines market entry for qualifying products but is temporary—approvals expire once the Therapeutic Goods Regulations are formally updated to permanently include these products in the listing system."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2012-no-5","history":"/api/acts/therapeutic-goods-listing-notice-2012-no-5/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2012-no-5/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2012-no-5/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2012-no-5/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2012-no-5/documents"}}