{"id":"F2021L01329","name":"Therapeutic Goods (Biologicals—Specified Things) Instrument 2021","slug":"therapeutic-goods-biologicals-specified-things-instrument-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441007,"registerId":"F2021L01329-fast-fetch-1775956442045","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Biologicals—Specified Things) Instrument 2021","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 (Biologicals—Specified Things) Instrument 2021\n\nI, John Skerritt, as delegate of the Secretary of the Department of Health, make the following instrument.\n\nDated 24 September 2021\n\nAdjunct Professor John Skerritt  Deputy Secretary  Health 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  Specified things—biologicals\n\n6  Specified things—not biologicals\n\n7  Repeals\n\nSchedule 1—Specified things: biologicals\n\nSchedule 2—Specified things: not biologicals\n\nSchedule 3—Repeals\n\nTherapeutic Goods (Things that are Biologicals) Specification 2019\n\nTherapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Biologicals—Specified Things) Instrument 2021.\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 30 September 2021. 30 September 2021\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 32A 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) biological.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nbiological medicine has the same meaning as in the Regulations.\n\nfaecal microbiota transplant product has the same meaning as in the Regulations.\n\nin-house IVD medical device has the same meaning as in the Medical Devices Regulations.\n\nIVD medical device has the same meaning as in the Medical Devices Regulations.\n\nMedical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\n5  Specified things—biologicals\n\n  For subsection 32A(2) of the Act, the things mentioned in Schedule 1 are specified for the purposes of subparagraph 32A(1)(a)(ii) of the Act.\n\n6  Specified things—not biologicals\n\n  For subsection 32A(3) of the Act, the things specified in Schedule 2 are determined not to be biologicals for the purposes of the Act.\n\n7  Repeals\n\n  Each instrument that is specified in Schedule 3 is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Specified things: biologicals\n\nNote: See section 5.\n\n- Specified things for the purposes of subparagraph 32A(1)(a)(ii) of the Act\n- Column 1 Column 2\n- Item Specified things\n- 1 a thing that comprises or contains live animal cells, tissues, or organs\n- 2 a thing that is a faecal microbiota transplant product\n\n\n\n\n\nSchedule 2—Specified things: not biologicals\n\nNote: See section 6.\n\n- Specified things that are not biologicals\n- Column 1 Column 2\n- Item Specified things\n- 1 biological medicines, other than vaccines that contain viable human cells\n- 2 haematopoietic progenitor cells used for haematopoietic reconstitution\n- 3 IVD medical devices and in-house IVD medical devices\n- 4 samples of human cell or tissue of an individual that are solely for diagnostic purposes in that individual\n\n\nNote: Biological medicines include blood and blood components.\n\n\n\n\nSchedule 3—Repeals\n\nNote: See section 7.\n\nTherapeutic Goods (Things that are Biologicals) Specification 2019\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\nTherapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011\n\n2  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument repeals the Therapeutic Goods (Things that are Biologicals) Specification 2019 and the Therapeutic Goods (Things that are not Biologicals) Determination No.1 of 2011 (see s7 and Schedule 3) and re-specifies which items are treated as biologicals (Schedule 1) and which are not (Schedule 2). The instrument therefore replaces prior instruments in force; determining whether the substantive list of covered or excluded items differs materially requires a direct textual comparison with the repealed instruments."},"complexity_factors":["Short, enumerative scope: the core rules are simple lists in Schedule 1 and Schedule 2 (low intrinsic textual complexity).","Cross-references to other instruments and definitions: relies on defined terms in the Act, the Therapeutic Goods Regulations 1990 and the Medical Devices Regulations 2002 (see s4), requiring users to consult multiple instruments to determine coverage.","Borderline/interpretation issues: open-ended language such as \"comprises or contains live animal cells, tissues, or organs\" (Schedule 1, item 1) may generate questions at product margins about when an item meets the description.","Overlap and interaction with device regulation: excluding IVD medical devices and in-house IVDs (Schedule 2, item 3) creates an interface with the Medical Devices Regulations that may require cross-regulatory mapping.","Dependency on external definitions: terms like \"biological medicine\" and \"faecal microbiota transplant product\" are defined elsewhere (s4), so practical application depends on those definitions' scope.","Regulatory transition effect: the instrument expressly repeals earlier instruments (s7 and Schedule 3), which creates administrative transition and may require sponsors to reassess classification and compliance pathways."],"plain_english_summary":"This instrument lists specific items that are to be treated as \"biologicals\" under the Therapeutic Goods Act (notably things containing live animal cells/tissues/organs and faecal microbiota transplant products) and lists items that are not biologicals (including most biological medicines, certain haematopoietic cells, IVDs, and diagnostic-only human samples). It commences 30 September 2021 and repeals two earlier instruments. It matters because the classification determines which regulatory regime, approvals and compliance obligations apply to sponsors, manufacturers, labs and clinicians."},"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"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument maintains the original scope of section 32A of the Therapeutic Goods Act 1989, which has always been about specifying what is and isn't a 'biological' for regulatory purposes. It consolidates two previous instruments (the 2019 Specification and 2011 Determination) into a single instrument without expanding the substantive scope. The classifications remain consistent with prior regulatory approach."},"complexity_factors":["Very short instrument: only 7 operative sections plus 3 schedules","Minimal defined terms: only 6 definitions in section 4, mostly referencing external regulations","No nested conditional logic or cross-referencing between sections","Straightforward tabular format for specifications in Schedules 1 and 2","Simple repeal mechanism in Schedule 3 with no transitional provisions","Operative provisions (sections 5-6) are single-sentence directives referencing schedules"],"plain_english_summary":"This instrument clarifies which products count as \"biologicals\" under the Therapeutic Goods Act 1989, bringing items like animal‑cell/tissue products and faecal microbiota transplants into the biological category while carving out many traditional blood/plasma therapies, certain stem‑cell uses, diagnostic devices, and diagnostic-only tissue samples. \n\nThat classification shifts regulatory requirements for developers, hospitals, labs and patients by changing which safety, approval, and oversight rules apply."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021","history":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021/history","analysis":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021/analysis","conflicts":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021/important-cases","documents":"/api/acts/therapeutic-goods-biologicals-specified-things-instrument-2021/documents"}}