{"id":"F2023L00742","name":"Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023","slug":"therapeutic-goods-advisory-committees-information-sharing-information-specification-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441917,"registerId":"F2023L00742-fast-fetch-1775957082580","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023","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 (Advisory Committees—Information Sharing) (Information) Specification 2023\n\nI, Chris Bedford, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 7 June 2023\n\nChris Bedford\n\nActing First Assistant Secretary  Regulatory Practice and Support Division  Health Products Regulation Group  Department of Health and Aged Care\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Release of therapeutic goods information\n\n6  Repeals\n\nSchedule 1—Therapeutic goods information\n\nSchedule 2—Repeals\n\nTherapeutic Goods Information (Sharing of Committee Information) Specification 2017\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Advisory Committees—Information Sharing) (Information) Specification 2023.\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of this instrument 1 July 2023. 1 July 2023\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5AB) of the Act.\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) Secretary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nadvisory committee means an advisory committee that is established under Part 6 of the Regulations and includes any of the committees previously established under the Regulations.\n\nadvisory committee advice means advice or recommendations provided by an advisory committee to the Minister or the Secretary in relation to a matter or item considered by an advisory committee at an advisory committee meeting.\n\nmeeting statement means a description of outcomes arising from an advisory committee meeting.\n\nrelevant persons or bodies means any of the following bodies, and employees, members or agents of these bodies:\n\n (a) the Advisory Committee on Biologicals (ACB), and any subcommittee of the ACB;\n\n (b) the Advisory Committee on Chemicals Scheduling (ACCS), and any subcommittee of the ACCS;\n\n (c) the Advisory Committee on Complementary Medicines (ACCM), and any subcommittee of the ACCM;\n\n (d) the Advisory Committee on Medical Devices (ACMD), and any subcommittee of the ACMD;\n\n (e) the Advisory Committee on Medicines (ACM), and any subcommittee of the ACM;\n\n (f) the Advisory Committee on Medicines Scheduling (ACMS), and any subcommittee of the ACMS;\n\n (g) the Advisory Committee on Vaccines (ACV), and any subcommittee of the ACV;\n\n (h) the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR);\n\n (i) the Australian Technical Advisory Group on Immunisation (ATAGI);\n\n (j) the Cardiac Prostheses Clinical Advisory Group;\n\n (k) the Cardiothoracic Prostheses Clinical Advisory Group;\n\n (l) the Hip Prostheses Clinical Advisory Group;\n\n (m) the Knee Prostheses Clinical Advisory Group;\n\n (n) the Medical Devices and Human Tissue Advisory Committee (MDHTAC), and any subcommittee of the MDHTAC;\n\n (o) the Medical Services Advisory Committee (MSAC), and any subcommittee of the MSAC;\n\n (p) the National Centre for Immunisation Research and Surveillance (NCIRS);\n\n (q) the National Immunisation Committee (NIC);\n\n (r) the Ophthalmic Prostheses Clinical Advisory Group;\n\n (s) the Pharmaceutical Benefits Advisory Committee (PBAC), and any subcommittee of the PBAC;\n\n (t) the Specialist Orthopaedic Clinical Advisory Group;\n\n (u) the Spinal Prostheses Clinical Advisory Group;\n\n (v) the Vascular Prostheses Clinical Advisory Group.\n\nRegulations mean the Therapeutic Goods Regulations 1990.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Release of therapeutic goods information\n\n  For subsection 61(5AA) of the Act, in relation to each item in the table in Schedule 1, the kinds of therapeutic goods information specified in column 2 may be released to a person, body or authority (or kinds of persons, bodies or authorities) specified in column 3, for the purposes specified in column 4.\n\nNote: Under subsection 61(5AA) of the Act, the Secretary may release to a person, body or authority that is specified (or that is of a kind specified) under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.\n\n6  Repeals\n\n  Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Therapeutic goods information that may be released\n- Column 1 Column 2 Column 3 Column 4\n- Item Kinds of information Persons or bodies Purposes\n- 1 information that relates to an advisory committee, that is contained in any of the following:(a) advisory committee advice;(b) agenda papers for advisory committee meetings;(c) meeting statements;(d) minutes of advisory committee meetings relevant persons or bodies to facilitate the sharing and consideration of information that is in the interests of public health and safety, including information relating to:(a) the safety of therapeutic goods; or(b) the efficacy or performance of therapeutic goods\n\n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods Information (Sharing of Committee Information) Specification 2017\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"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":2,"scope_assessment":{"changed":false,"description":"The instrument replaces the 2017 specification (see s6 and Schedule 2) and expressly authorises release of specified advisory-committee information to a listed set of bodies for public health and safety purposes (s5, Schedule 1). On its face the authorised scope remains a focused, sharing-only regime limited to the named information types and recipients, so there is no apparent material expansion of scope within this text."},"complexity_factors":["Narrow, well-defined subject matter: authorisation to release advisory-committee-related therapeutic goods information (Schedule 1).","Relies on statutory cross-references: authorising power and definitions depend on Therapeutic Goods Act 1989 (subsection 61(5AA), s61(1)) and Regulations (Part 6) for committee establishment.","List-driven mechanics: explicit list of recipient bodies and types of information reduces interpretive ambiguity.","Administrative discretion: Secretary has authority to release information under s61(5AA), creating an implementation discretion point.","Instrument-level change: repeals earlier 2017 specification (s6 / Schedule 2), so practitioners must update references and reliance on the prior instrument.","Low compliance burden: instrument permits release rather than imposing obligations on private parties or new procedural requirements."],"plain_english_summary":"This specification authorises the Secretary to release advisory-committee-related therapeutic goods information (advice, agenda papers, meeting statements, minutes) to a listed set of advisory committees and specified health bodies for public‑health and safety purposes (see s5 and Schedule 1). It repeals the 2017 specification (s6) and therefore affects advisory committees, departmental officials and the listed external bodies by permitting information sharing; the Secretary decides what is released under subsection 61(5AA) of the Act."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument maintains the same narrow scope as its 2017 predecessor — authorising information sharing between advisory committees for public health purposes. The 2023 version updates the list of recipient bodies (expanding from the previous specification) but does not expand the underlying purpose or mechanism beyond the original legislative intent."},"complexity_factors":["Short instrument: only 6 substantive sections plus 2 schedules","Single operational mechanism: a table in Schedule 1 authorising information release to specific bodies","Minimal conditional logic: no nested exceptions or complex triggering conditions","Straightforward definitions: 5 defined terms in section 4, all referencing existing legislation","No cross-referencing maze: only references to the Therapeutic Goods Act 1989 and Regulations 1990","Simple repeal mechanism: Schedule 2 repeals one previous instrument in its entirety"],"plain_english_summary":"This law lets the Health Secretary disclose otherwise confidential advice and meeting information from therapeutic goods advisory committees to a specified list of other health advisory bodies so they can jointly protect public health — especially the safety, effectiveness or performance of medicines, vaccines, devices and biological products.\n\nIt affects advisory committees under the Therapeutic Goods Act and the 22 named recipient bodies (e.g., PBAC, ATAGI, device registries) and replaces the 2017 version, updating who may receive information."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023","history":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023/history","analysis":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023/analysis","conflicts":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023/conflicts","importantCases":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023/important-cases","documents":"/api/acts/therapeutic-goods-advisory-committees-information-sharing-information-specification-2023/documents"}}