{"id":"F2020L00369","name":"Therapeutic Goods (Guidelines for Multi-Site Licences) Instrument 2020","slug":"therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440437,"registerId":"F2020L00369-fast-fetch-1775956059725","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Guidelines for Multi-Site Licences) Instrument 2020","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 (Guidelines for Multi-Site Licences) Instrument 2020\n\nI, Tracey Duffy, as delegate of the Secretary of the Department of Health, make the following instrument.\n\nDated 31 March 2020\n\nTracey Duffy\n\nFirst Assistant Secretary\n\nMedical Devices and Product Quality 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  Circumstances for multi-site licence—manufacture of therapeutic goods other than blood, blood components, plasma, haematopoietic progenitor cells or human tissue\n\n6  Circumstances for multi-site licence—manufacture of blood, blood components, plasma, haematopoietic progenitor cells or human tissue\n\n7  Repeals\n\nSchedule 1—Repeals\n\nTherapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2010\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Guidelines for Multi-Site Licences) Instrument 2020.\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 The day after this instrument is registered. 1 April 2020\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 38A 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) licence;\n\n(b) manufacture;\n\n(c) medicine;\n\n(d)  supply; and\n\n(e) 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\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\nin-process material means partly processed starting material that must undergo further manufacturing before it becomes therapeutic goods in final dosage form.\n\npackaging material, in relation to therapeutic goods, means any material used in the packaging of the therapeutic goods, excluding any outer packaging or container required solely to transport the therapeutic goods.\n\nplasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.\n\nquality system means the organisational structure, responsibilities, procedures, instructions, processes and resources for implementing quality management.\n\nsecondary-packaging, in relation to therapeutic goods, means packaging that is not designed to be in direct contact with the goods.\n\nstarting material means:\n\n (a) in relation to therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue—any material used in the manufacture of the therapeutic goods, but excluding packaging material;\n\n (b) in relation to therapeutic goods that are blood, blood components, haematopoietic progenitor cells or human tissue—any material used in the manufacture of the therapeutic goods that may contact, or be included as an ingredient or component in, the therapeutic goods.\n\n5  Circumstances for multi-site licence—manufacture of therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue\n\n (1) This section applies to the manufacture of therapeutic goods other than blood, blood components, haematopoietic progenitor cells or human tissue.\n\n (2) A licence may cover two or more manufacturing sites where all of the following paragraphs apply:\n\n (a) steps in the manufacture of the therapeutic goods are to be carried out at one fixed site, and any additional site or sites are to be used for carrying out the following steps:\n\n (i) the storage of primary packaging materials, starting materials, in-process materials or finished product; or\n\n (ii) the secondary packaging of finished product; or\n\n (iii) the release for supply of packaging materials, starting materials, in-process materials, or finished product; and\n\n (b) all steps in the manufacture of the therapeutic goods are to be covered by a single quality system; and\n\n (c) all sites are capable of being inspected within the relevant period; and\n\n (d) all sites are located with sufficient proximity such that the total travel time between the sites under inspection does not exceed 60 minutes.\n\n6  Circumstances for multi-site licence—manufacture of blood, blood components, haematopoietic progenitor cells or human tissue\n\n (1) This section applies to the manufacture of therapeutic goods that are blood, blood components, haematopoietic progenitor cells or human tissue.\n\n (2) A licence may cover two or more manufacturing sites where all of the following paragraphs apply:\n\n (a) steps in the manufacture of the therapeutic goods are to be carried out at one fixed site, and any additional site or sites are to be used for carrying out the following steps:\n\n (i) in relation to a fixed site—the storage of packaging materials, starting materials, in-process materials, or finished product;\n\n (ii) in relation to a mobile (non-fixed) site—the collection of blood or blood components; and\n\n (b) all steps in the manufacture of the therapeutic goods are to be covered by a single quality system; and\n\n (c) all sites are capable of being inspected within the relevant period; and\n\n (d) all sites are located with sufficient proximity such that the total travel time between the sites under inspection does not exceed 60 minutes.\n\n7  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\nTherapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2010\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument directly replaces the 2010 Guidelines with substantially the same scope. It maintains the same core purpose (setting conditions for multi-site licences) and covers the same categories of therapeutic goods. The structure and requirements remain largely consistent with the original intent."},"complexity_factors":["Short instrument (approximately 1,500 words)","Only 7 defined terms in section 4, plus 5 terms referenced from the parent Act","Clear binary structure: two parallel sections (5 and 6) for two categories of goods","Simple conditional logic: four cumulative requirements (paragraphs a-d) that must all be satisfied","No nested exceptions or cross-references to other legislation beyond the parent Act definitions","Straightforward repeal of a single previous instrument in Schedule 1"],"plain_english_summary":"This law lets a pharmaceutical or medical device company hold a single manufacturing licence that covers multiple nearby sites instead of separate licences, affecting manufacturers and the TGA. It permits extra sites only for limited activities depending on the product (storage, secondary packaging/release for most goods; storage or mobile blood collection for blood/tissue), requires a single quality system, inspectability and sites within 60 minutes’ travel. It cuts red tape while keeping safety standards and replaces the 2010 guidance."},"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"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"Based solely on this instrument, the scope of who may hold a multi-site manufacturing licence is not expanded—this instrument prescribes specific operational, quality-system and inspection conditions (including a 60‑minute inspection travel limit) and replaces the 2010 Guidelines rather than widening licence eligibility."},"complexity_factors":["Clear, narrow scope limited to multi-site manufacturing licence criteria rather than broad regulatory reform (whole instrument is short).","Distinct rules for non-blood products (s5) and blood/blood-component products (s6) increase branching in application.","Operational requirements with a precise travel-time threshold (60 minutes) create a quantitative compliance check (s5(2)(d), s6(2)(d)).","Single quality system requirement means organisational alignment across sites is necessary (s5(2)(b), s6(2)(b)).","Inspection-capability requirement imposes administrative scheduling and logistical burdens on applicants (s5(2)(c), s6(2)(c)).","Definitions of terms like starting material, in-process material, and packaging material create dependency on precise meaning for application (s4).","Separate allowance for mobile (non-fixed) collection sites for blood products introduces operational complexity for blood manufacturers (s6(2)(a)(ii)).","Instrument is a delegated administrative instrument under s38A of the Act, so practical effect depends on departmental implementation and enforcement (s3).","Repeal of the 2010 Guidelines replaces prior administrative guidance and may require transitional adjustments by affected licensees (s7, Schedule 1)."],"plain_english_summary":"This instrument sets the rules for when one manufacturing licence can cover multiple sites that make therapeutic goods. It specifies allowed activities at additional sites, requires a single quality system, that all sites be inspectable within the relevant period, and that total on‑site travel time for inspection not exceed 60 minutes, with separate provisions for blood-related products. It affects manufacturers seeking multi-site licences and regulators checking compliance, because it fixes operational and inspection constraints that determine who can be licensed together."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020","history":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020/history","analysis":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020/analysis","conflicts":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020/important-cases","documents":"/api/acts/therapeutic-goods-guidelines-for-multi-site-licences-instrument-2020/documents"}}