{"id":"F2022L00100","name":"Therapeutic Goods (Advisory Committee Meetings) (Information) Specification 2022","slug":"therapeutic-goods-advisory-committee-meetings-information-specification-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441194,"registerId":"F2022L00100-fast-fetch-1775956556897","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Advisory Committee Meetings) (Information) Specification 2022","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 (Advisory Committee Meetings) (Information) Specification 2022\n\n \n\nI, Jane Cook as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 1 February 2022\n\nDr Jane Cook\n\nFirst Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Therapeutic goods information\n\n6  Repeals\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nSchedule 2—Repeals\n\nTherapeutic Goods Information (Information about Advisory Committee Meetings) Specification 2014\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Advisory Committee Meetings) (Information) Specification 2022\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day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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(5D) 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\n1.       Secretary.\n\n\n  In this instrument:\n\nAct means Therapeutic Goods Act 1989.\n\ncommittee means an advisory committee established under Part 6 of the Regulations.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Therapeutic goods information\n\nThe kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purpose of subsection 61(5C) of the Act.\n\nNote: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C) of the Act.\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—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1 Column 2\n- Item Kinds of Information\n- 1 information about the nature or content of any discussion about matters or items considered by a committee at a committee meeting, or a summary of such a discussion\n\n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods Information (Information about Advisory Committee Meetings) Specification 2014\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"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"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument repeals the 2014 specification and re‑enacts a specification that identifies one kind of releasable information—\"information about the nature or content of any discussion...or a summary\" (Schedule 1 Item 1). The instrument itself does not include the text of the 2014 specification, so the exact extent and direction of the change compared with the earlier instrument cannot be determined from the provided text alone (see s6; Schedule 2)."},"complexity_factors":["Relies on definitions and release powers located in the Therapeutic Goods Act 1989 (authority and operation depend on subsection references: s3; see s5 referencing subsection 61(5C) of the Act).","Short, single‑item content list (Schedule 1 Item 1) reduces internal complexity but increases reliance on how broad phrases like \"nature or content of any discussion\" are interpreted.","Delegated‑legislation form: made by a delegate (First Assistant Secretary) rather than Parliament, creating administrative discretion over publication (see instrument header and s3).","Repeal of prior instrument (s6; Schedule 2) means comparative scope depends on the repealed text, which is not reproduced here — potential uncertainty about change magnitude.","Operational complexity for agencies: Secretary must exercise discretion about release under subsection 61(5C) of the Act, creating administrative decision‑making and possible record‑management burdens (see s5).","Cross‑references to external instruments and Act definitions increase legal interpretive steps required for compliance and advice (Definitions section and note referencing subsection 3(1) of the Act)."],"plain_english_summary":"This specification tells the Secretary what kinds of advisory‑committee meeting material may be released to the public — limited to descriptions or summaries of the nature or content of committee discussions (see s5; Schedule 1 Item 1). It is a delegated instrument made under the Therapeutic Goods Act 1989, replaces the 2014 specification, and leaves publication decisions to the Secretary under the Act, with interpretation depending on Act definitions and administrative judgement (see s3; s6)."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument maintains the same narrow scope as its predecessor. It simply updates the legislative vehicle (repealing the 2014 version) while preserving the same function: specifying that information about advisory committee discussions can be released to the public. There is no expansion of scope beyond the original purpose of enabling transparency around advisory committee deliberations."},"complexity_factors":["Very short instrument (6 sections plus 2 schedules)","Only 4 defined terms in section 4 (Act, committee, Regulations, therapeutic goods information)","Minimal cross-referencing — only references to the parent Act (Therapeutic Goods Act 1989) and Regulations","Simple structure: definitions, operative provision (section 5), and repeal schedule","No conditional logic, exceptions, or nested provisions","Single substantive provision specifying one category of releasable information"],"plain_english_summary":"This law lets the Secretary of the Department of Health publish information about discussions and summaries from advisory committees that advise on therapeutic goods (medicines, devices, biologicals), replacing a 2014 version.  \n\nIt increases transparency for the public, industry stakeholders, and committee members by making committee deliberations and the basis for regulatory advice more accessible."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022","history":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022/history","analysis":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022/analysis","conflicts":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022/important-cases","documents":"/api/acts/therapeutic-goods-advisory-committee-meetings-information-specification-2022/documents"}}