{"id":"F2011L02128","name":"Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (18/10/2011)","slug":"therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":87529,"registerId":"commonwealth-F2011L02128-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines (18/10/2011)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\ntitle: Letterhead\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n \n\nTHERAPEUTIC GOODS ACT 1989\n\n \n\n Therapeutic Goods Order No. 89 Standard for water for injections for parenteral medicines\n\n \n\nI, Rohan Hammett, delegate of the Minister for Health and Ageing for the purposes of section 10 of the Therapeutic Goods Act 1989 (‘the Act’) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act, HEREBY DETERMINE that matters specified in this Order constitute a standard for water for injections:\n\n1. for therapeutic use as a parenteral medicine; or\n2. for use as an ingredient or component in the manufacture of a parenteral medicine\n\n\nother than for:\n\nc.   an export only medicine; or\n\nd.   a personal import as described under Item 1 of Schedule 5 of the Therapeutic Goods Regulations 1990.\n\n \n\n## Standard\n\nWater for injections must comply with the monograph for Water for Injections in the British Pharmacopoeia or the European Pharmacopoeia.\n\n \n\n## Definitions\n\nIn this Order:\n\nmonograph means the requirements of, and definitions within, an individual or general monograph of the British Pharmacopoeia or the European Pharmacopoeia, read in conjunction with the General Notices contained in the same edition that are applicable to that monograph.\n\n \n\nparenteral medicine means a sterile medicine intended for administration by injection, infusion or implantation into the body.\n\n \n\n## Commencement\n\nThis Order commences from the day after the day it is registered on the Federal Register of Legislative Instruments.\n\n \n\n \n\nDated this 18th day of October 2011\n\n \n\n \n\n \n\n(signed by)\n\n \n\nRohan Hammett\n\nDelegate of the Minister for Health and Ageing\n","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1558},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is the original 2011 instrument establishing the standard; the scope remains precisely limited to water for injections intended for domestic therapeutic use or manufacturing, with specific carve-outs for exports and personal imports."},"complexity_factors":["Only 2 defined terms in the interpretation section","Single operative provision incorporating external standards by reference to British or European Pharmacopoeia","Two straightforward exemptions without nested conditions or exceptions","No internal cross-references between sections"],"plain_english_summary":"This law makes the British or European Pharmacopoeia the mandatory quality standard for sterile “water for injections” used in Australia. It applies to pharmaceutical manufacturers, compounding pharmacies, and healthcare providers who prepare or use injectable medicines.\n\nIt does not cover water in medicines made in Australia solely for export or in medicines personally imported for an individual. The change reduces the risk of contamination in injections, protecting patients from potentially fatal infections."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011","history":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011/history","analysis":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011/important-cases","documents":"/api/acts/therapeutic-goods-order-no-89-standard-for-water-for-injections-for-parenteral-medicines-18-10-2011/documents"}}