{"id":"F2013L01921","name":"Therapeutic Goods (Listing) Notice 2013 (No. 3)","slug":"therapeutic-goods-listing-notice-2013-no-3","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":128054,"registerId":"commonwealth-F2013L01921-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Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listing) Notice 2013 (No. 3)","content":"Therapeutic Goods Act 1989\n\nTherapeutic Goods (Listing) Notice 2013 (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 ‘DHA/EPA rich Schizochytrium algal oil’ as a therapeutically active ingredient, subject to the following conditions:\n    -   the preparations are for oral use only; and\n    -   the ratio of docosahexaenoic acid (DHA) to eicosapentaenoic acid (EPA) in ‘DHA/EPA rich Schizochytrium algal oil’ is 2:1; and\n    -   that ‘DHA/EPA rich Schizochytrium algal oil’ 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":1421},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The notice performs exactly the narrow, temporary listing function authorized by section 9A(5) of the Therapeutic Goods Act 1989. It has not expanded beyond its original administrative purpose."},"complexity_factors":["Single, narrowly defined category of therapeutic goods (DHA/EPA rich Schizochytrium algal oil preparations)","Four cumulative technical conditions restricting formulation and presentation","Temporary operation with automatic sunset clause tied to future regulatory amendments","Cross-references to Item 3 of Part 1 of Schedule 4 of the Therapeutic Goods Regulations 1990 for the listing pathway"],"plain_english_summary":"This notice temporarily permits supplements containing oil from Schizochytrium algae to be listed on the Australian Register of Therapeutic Goods, allowing them to be legally sold while permanent rules are developed. It only covers oral medicinal forms that mix the oil with other ingredients and meet a 2:1 DHA-to-EPA ratio. This affects manufacturers, sellers and consumers by providing immediate market access pending regulatory change."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listing-notice-2013-no-3","history":"/api/acts/therapeutic-goods-listing-notice-2013-no-3/history","analysis":"/api/acts/therapeutic-goods-listing-notice-2013-no-3/analysis","conflicts":"/api/acts/therapeutic-goods-listing-notice-2013-no-3/conflicts","importantCases":"/api/acts/therapeutic-goods-listing-notice-2013-no-3/important-cases","documents":"/api/acts/therapeutic-goods-listing-notice-2013-no-3/documents"}}