{"id":"F2022L00400","name":"Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022","slug":"therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441301,"registerId":"F2022L00400-fast-fetch-1775956636962","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022\n\nI, Nick Henderson, as delegate of the Minister for Health and Aged Care, make the following order.\n\nDated 25 March 2022\n\nNick Henderson\n\nFirst Assistant Secretary  Medicines Regulation Division  Health Products Regulation Group  Department of Health\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Standard\n\n6  Application\n\n7  Requirements\n\n8  Repeals\n\nSchedule 1—Repeals\n\nTherapeutic Goods Order No. 90 Standard for human albumin\n\n \n\n1  Name\n\n (1) This instrument is the Therapeutic Goods (Standard for Human Albumin) (TGO 111) Order 2022.\n\n (2) This instrument may also be cited as TGO 111.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 31 March 2022. 31 March 2022\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under section 10 of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) British Pharmacopoeia;\n\n(b) European Pharmacopoeia;\n\n(c) export only medicine;\n\n(d) standard;\n\n(e) therapeutic goods;\n\n(f) therapeutic use.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nhuman albumin means albumin derived from humans for:\n\n (a) therapeutic use; or\n\n (b) use as an ingredient or component in the manufacture of therapeutic goods other than a medical device.\n\n5  Standard\n\n  The matters specified in this instrument constitute a standard for human albumin.\n\n6  Application\n\n  This instrument applies to human albumin, other than human albumin that is:\n\n (a) an export only medicine; or\n\n (b) an ingredient or component in the manufacture of an export only medicine.\n\n7  Requirements\n\n  The requirements for human albumin are the requirements specified in an individual or general monograph in the British Pharmacopoeia or the European Pharmacopoeia that is applicable to human albumin, as interpreted in accordance with the General Notices section of the relevant Pharmacopoeia.\n\n8  Repeals\n\n  Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Repeals\n\nNote: See section 8.\n\nTherapeutic Goods Order No. 90 Standard for human albumin\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation maintains the same scope as its predecessor (TGO 90). It continues to regulate human albumin for therapeutic use in Australia, with the same export exemption. The only change is methodological — replacing duplicated technical specifications with incorporation by reference to international pharmacopoeias. This is a simplification of mechanism, not an expansion of scope."},"complexity_factors":["Very short instrument (8 sections plus a 1-item Schedule)","Only 2 defined terms in the instrument itself ('Act' and 'human albumin')","No nested exceptions or conditional logic — just a straightforward application rule with two simple carve-outs (export-only products)","Single operative requirement (section 7) that incorporates external standards by reference rather than setting out detailed technical specifications","No cross-references to other legislation beyond the parent Act (Therapeutic Goods Act 1989) and the two Pharmacopoeias","Clear linear structure: Name → Commencement → Authority → Definitions → Standard → Application → Requirements → Repeals"],"plain_english_summary":"This Order sets Australia’s official quality standard for human albumin used in treatment or as a medicine ingredient by requiring products sold here to meet the British or European Pharmacopoeia (including their General Notices).\n\nIt affects manufacturers, importers, healthcare providers and patients, excludes export‑only albumin, and replaces TGO No.90 by relying on established international standards to maintain safety and cut duplication."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The Order replaces Therapeutic Goods Order No. 90 (Schedule 1) but maintains the same functional role: it establishes a mandatory standard for human albumin by referencing pharmacopoeial monographs rather than creating new bespoke tests (s7, Schedule 1). It excludes export‑only products (s6). Practically, obligations remain with manufacturers and sponsors to apply and evidence compliance with the referenced Pharmacopoeia requirements; administrative enforcement derives from the Act under which the instrument is made (s3, s4)."},"complexity_factors":["References external, technical standards (British Pharmacopoeia or European Pharmacopoeia) rather than prescribing bespoke tests, requiring users to consult and apply those documents (s7).","Interpretation depends on the Pharmacopoeias’ General Notices, creating delegated interpretive reliance on non‑statutory texts (s7).","Scope carve‑out for export‑only products narrows application but necessitates classification decisions by sponsors/manufacturers (s6).","Relies on definitions taken from the Therapeutic Goods Act, producing cross‑reference complexity for terms like 'therapeutic use' and 'standard' (s4).","Repeals a prior instrument (TGO 90), so continuity and transitional compliance depend on comparing old and new text (Schedule 1).","Decision‑making and enforcement stem from the Therapeutic Goods Act delegation; administrative discretion in enforcement and interpretation may affect compliance outcomes (s3)."],"plain_english_summary":"This Order sets the legal quality standard for human‑derived albumin used in Australian therapeutic goods by requiring compliance with the applicable British or European Pharmacopoeia monograph. It excludes export‑only products and repeals the earlier TGO 90. Manufacturers and sponsors must meet the pharmacopoeial specifications as interpreted under those Pharmacopoeias’ General Notices."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022","history":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022/history","analysis":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-human-albumin-tgo-111-order-2022/documents"}}