{"id":"F2015L01469","name":"Therapeutic Goods (Listing) Notice 2015 (No. 5)","slug":"therapeutic-goods-listing-notice-2015-no-5","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":154562,"registerId":"commonwealth-F2015L01469-current","compilationNumber":null,"startDate":"2026-04-04","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2015 (No. 5)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2015 (No. 5)\n\nI, Trisha Garrett, First Assistant Secretary, Medicines Regulation of the Regulatory Services Group, delegate of the Minister for Health for the purposes of subsection 9A(5) of the Therapeutic Goods Act 1989 and acting under that provision, require the following therapeutic goods to be included in the part of the Australian Register of Therapeutic Goods for listed goods:\n\npreparations that contain ‘Levomefolate calcium’ as a therapeutically active ingredient, subject to the following conditions:\n\n    the preparation is for oral use only; and\n    either\n\n        the preparation provides not more than 500 µg of Levomefolic acid from Levomefolate calcium per daily dose; or\n        when used in combination with folic acid, folinic acid and/or their derivatives, the preparation provides not more than a total of 500 µg of folic acid, folinic acid and/or their derivatives in total per daily dose.\n\nThis Notice commences from the day after it is registered on the Federal Register of Legislative Instruments.\n\nDated this 17 day of September 2015\n\n(Signed by)\n\nTrisha Garrett\n\nDelegate of the Minister for Health","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":2102},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This notice maintains its original narrow scope of permitting a specific folate salt (Levomefolate calcium) for oral use with dosage limitations. It performs the standard function of a listing notice under the Therapeutic Goods Act without expanding into unrelated areas."},"complexity_factors":["Single active ingredient specified with clear route-of-administration restriction (oral only)","Simple binary condition for dosage compliance (single ingredient limit vs. combined total limit)","No defined terms or interpretation section","No cross-references to other legislative instruments beyond the enabling Act","Extremely short length with single operative provision"],"plain_english_summary":"This notice permits vitamin supplements containing levomefolate calcium (a form of folate) to be listed on the Australian Register of Therapeutic Goods (ARTG), creating a legal pathway for their sale. It affects manufacturers, suppliers, and consumers—particularly pregnant people or those planning pregnancy.\n\nProducts must be oral and limited to 500 µg levomefolic acid per daily dose, or a combined total of all folates no greater than 500 µg. This cap aims to enable supply while protecting consumers."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2015-no-5","history":"/api/acts/therapeutic-goods-listing-notice-2015-no-5/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2015-no-5/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2015-no-5/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2015-no-5/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2015-no-5/documents"}}