{"id":"F2013L01922","name":"Therapeutic Goods (Listing) Notice 2013 (No. 4)","slug":"therapeutic-goods-listing-notice-2013-no-4","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":128056,"registerId":"commonwealth-F2013L01922-current","compilationNumber":null,"startDate":"2026-04-03","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2013 (No. 4)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2013 (No. 4)\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 ‘Astaxanthin esters extracted from Haematococcus pluvialis’ as a therapeutically active ingredient, subject to the following conditions:\n\n-   the preparations are for oral use only; and\n-   the preparations provide not more than 12 mg of astaxanthin per daily dose; and\n-   ‘Astaxanthin esters extracted from Haematococcus pluvialis’ is present in combination with other ingredients; and\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 1st day of November 2013\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":1777},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"This is a standard administrative listing notice under subsection 9A(5) of the Therapeutic Goods Act 1989, performing exactly the function intended by that provision—interim listing of specific therapeutic goods pending formal regulatory amendment."},"complexity_factors":["Single operative provision containing only four bullet-pointed conditions","No definitions section, interpretation clauses, or technical appendices","Linear logical structure with no exceptions, sub-exceptions, or nested conditional logic","Minimal cross-referencing (only standard citations to empowering Act and Regulations)","Extremely short length (under 250 words)"],"plain_english_summary":"This notice temporarily approves a specific antioxidant—**astaxanthin esters extracted from *Haematococcus pluvialis*** (a microalgae)—for sale in Australia as a “listed” medicine. Listed medicines are lower-risk health products (like vitamins and supplements) that must meet safety standards but don’t require individual pre-approval like prescription drugs.\n\nThe approval allows products containing this ingredient only if they meet four strict conditions:\n*   **Swallowed only** – must be for oral use (not creams or injections)\n*   **Dose cap** – no more than 12 milligrams per day\n*   **Combination products only** – cannot be sold as pure astaxanthin; must be mixed with other ingredients\n*   **Medicinal presentation** – must be sold in a therapeutic form (such as capsules or tablets) for health purposes\n\nThis listing acts as a temporary “bridge” until permanent regulations are enacted to formally include this ingredient in the Australian Register of Therapeutic Goods."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2013-no-4","history":"/api/acts/therapeutic-goods-listing-notice-2013-no-4/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2013-no-4/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2013-no-4/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2013-no-4/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2013-no-4/documents"}}