{"id":"F2019L00389","name":"Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019","slug":"therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439995,"registerId":"F2019L00389-fast-fetch-1775955799075","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\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 Blood and Blood Components) (TGO 102) Order 2019\n\nI, Jane Cook, as delegate of the Minister for Health, make the following order.\n\nDated 22 March 2019\n\nJane Cook\n\nFirst Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment 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  Transitional arrangements\n\n9  Repeals\n\n10  Consequential amendments\n\nSchedule 1—Repeals\n\nTherapeutic Goods Order No 81 Standards for Blood and Blood Components\n\nSchedule 2—Consequential amendments\n\nTherapeutic Goods (Manufacturing Principles) Determination 2018\n\n \n\n1  Name\n\n (1) This instrument is the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.\n\n (2) This instrument may also be cited as TGO 102.\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instrument 31 March 2019. 31 March 2019\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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 sections 10 and 36 of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n(a) manufacture; and\n\n(b) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nblood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.\n\nblood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:\n\n (a) red cells;\n\n (b) white cells;\n\n (c) platelets;\n\n (d) plasma;\n\nbut does not include haematopoietic progenitor cells.\n\nGuide means the Guide to the preparation, use and quality assurance of blood components, 19th edition, 2017, published by the Council of Europe, as in force or existing immediately before the commencement of this instrument.\n\nNote: The Guide is published by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe at: www.edqm.eu.\n\nhaematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\nHBV means hepatitis B virus.\n\nHCV means hepatitis C virus.\n\nHIV-1 means human immunodeficiency virus.\n\n5  Standard\n\n  This instrument constitutes a standard for blood and blood components.\n\n6  Application\n\n (1) Subject to subsection (2), this instrument applies to therapeutic goods that are blood and blood components.\n\n (2) This instrument does not apply to therapeutic goods that are:\n\n (a) collected by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, in the course of medical treatment and for the purposes of diagnosis of, and testing for, a medical condition;\n\n (b) manufactured by a medical practitioner, registered under a law of a State or Territory, or a person under the professional supervision of such a practitioner, for therapeutic application to a patient under the practitioner’s care; or\n\n (c) manufactured by a blood donation centre for a medical practitioner, registered under a law of a State or Territory, for therapeutic application to a particular patient under the practitioner’s care.\n\n7  Requirements\n\n (1) The requirements in relation to blood and blood components are:\n\n (a) subject to subsection (2), those requirements specified in the Guide; and\n\n (b) those requirements specified in subsections (3) and (4).\n\n (2) The reference to ‘tropical areas’ in relation to the deferral period for the condition Tropical infections in Table 2.2. Conditions leading to temporary deferral (suspension) on page 253 of the Guide is to be taken not to include areas within Australia.\n\nNote: For the definition of Guide, see section 4.\n\n (3) Blood and blood components must only be manufactured from blood where samples of that blood test negative for HBV, HCV and HIV-1, using\n\nnucleic acid amplification technology.\n\n (4) Blood and blood components must not be manufactured from a donor:\n\n (a) who lived in, or visited, England, Scotland, Wales, Northern Ireland or the Isle of Man for a cumulative period of 6 months or more, at any time on or between 1 January 1980 and 31 December 1996; or\n\n (b) who received a transfusion or injection of blood or blood products while in England, Scotland, Wales, Northern Island or the Isle of Man, at any time on or after 1 January 1980.\n\n8  Transitional arrangements\n\n (1) In this section:\n\n  former instrument means the Therapeutic Goods Order No. 81 – Standards for Blood and Blood Components, as in force immediately before the commencement of this instrument.\n\n  transition period means the period beginning on 31 March 2019 and ending on 30 March 2020.\n\n (2) Despite the repeal of the former instrument by section 9 of this instrument, the former instrument continues to apply for the duration of the transition period, such that the standard for blood and blood components constituted by the former instrument may be conformed with as an alternative to the standard for blood and blood components constituted by this instrument.\n\n9  Repeals\n\n  Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in the applicable items in that Schedule.\n\n10  Consequential amendments\n\n  Each instrument that is specified in Schedule 2 to this instrument is amended as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Repeals\n\nNote: See section 9.\n\nTherapeutic Goods Order No 81 Standards for Blood and Blood Components\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n\n\n\nSchedule 2—Consequential amendments\n\nNote: See section 10.\n\nTherapeutic Goods (Manufacturing Principles) Determination 2018\n\n1  Section 4 (paragraph b of the definition of Technical Master File)\n\nOmit “Therapeutic Goods Order No.81 – Standards for Blood and Blood Components”, substitute “Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019”.\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument replaces Therapeutic Goods Order No.81 (s9; Sch 1) and retains the Council of Europe Guide as the baseline (s4; s7(1)(a)) while introducing clearer, mandatory testing and donor‑eligibility mechanics: compulsory nucleic acid amplification tests for HBV, HCV and HIV‑1 (s7(3)), and explicit donor exclusions tied to specified UK residency/transfusion histories (s7(4)). It excludes haematopoietic progenitor cells by definition (s4) and exempts practitioner‑collected or practitioner‑manufactured blood from the instrument (s6(2)). A 12‑month transition permits reliance on the former standard until 30 March 2020 (s8). These changes narrow and clarify procedural and testing obligations compared with the former instrument and create concrete compliance and operational effects for blood establishments and testing laboratories (see s7(3), s7(4), s8)."},"complexity_factors":["Adopts an external technical document (Guide) as the baseline standard, creating dependency on an off‑instrument source for many requirements (s4; s7(1)(a)).","Cross‑references to the Therapeutic Goods Act 1989 and defined terms increase interpretive steps (definition of Act; note referencing s3 of the Act) (s4).","Specific laboratory requirement: mandatory nucleic acid amplification testing for HBV, HCV and HIV‑1—introduces a clear technical compliance obligation for manufacturers and testing labs (s7(3)).","Historic, time‑bounded donor exclusions based on residence and transfusion history in the UK add a non‑medical eligibility rule with precise temporal/geographic criteria (s7(4)).","Explicit scope carve‑outs for practitioner‑collected or practitioner‑manufactured material narrow application and create compliance boundaries (s6(2)).","Transitional arrangement allowing conformity with the former instrument for 12 months requires firms to manage dual compliance regimes during transition (s8).","Repeal of the prior instrument and consequential amendments to other instruments requires co‑ordinated regulatory updates (s9; Schedule 1; Schedule 2)."],"plain_english_summary":"This Order (TGO 102) replaces the previous blood standard and sets mandatory quality requirements for human blood and common blood components. It adopts the Council of Europe Guide as the baseline, requires nucleic‑acid tests for HBV, HCV and HIV‑1, excludes donors with specified UK residence or transfusion histories, and provides a 12‑month transition allowing use of the prior standard."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation maintains the same scope as its predecessor (TGO 81). It continues to regulate blood and blood components for therapeutic use, with the same exemptions for practitioner-collected blood. The update represents a standards refresh rather than scope expansion — replacing an outdated standard with a current international benchmark while preserving the original regulatory intent."},"complexity_factors":["Incorporation by reference of external document (Council of Europe Guide, 19th edition) — users must consult separate 250+ page document","Specific date-based exclusion criteria for UK donors requiring cumulative period calculation (6 months between 1980–1996)","Conditional application rules with three explicit exemptions in section 6(2)","Transitional arrangements creating dual-standard system for 12-month period","Technical terminology requiring definitions (nucleic acid amplification technology, haematopoietic progenitor cells)","Consequential amendments to separate instrument requiring cross-referencing"],"plain_english_summary":"This instrument replaces TGO 81 with TGO 102, adopting by reference the Council of Europe Guide (19th ed.) to set Australia’s safety and quality rules for blood and blood products. It adds Australian requirements: nucleic acid testing for HBV, HCV and HIV; donor deferral for people resident in the UK 1980–1996 or transfused there after 1980 to reduce vCJD risk; and a clarification excluding tropical Australia from the Guide’s “tropical areas” for deferral decisions.\n\nIt affects blood services, hospitals and donors and had a one‑year transition to implementation."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019","history":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019/history","analysis":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-blood-and-blood-components-tgo-102-order-2019/documents"}}