{"id":"F2022L00189","name":"Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022","slug":"therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441230,"registerId":"F2022L00189-fast-fetch-1775956599700","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (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 (Analysis of Adverse Events Following Immunisation) (Information) Specification 2022\n\nI, Nick Henderson, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 24 February 2022\n\nNick Henderson\n\nFirst Assistant Secretary  Medicines Regulation Division  Health Products Regulation Group  Department of Health\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\nSchedule 1—Therapeutic goods information\n\nPart 1—NCIRS\n\nPart 2—SAEFVIC\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Analysis of Adverse Events Following Immunisation) (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The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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(5AB) 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) Secretary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nAEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration.\n\nAIR means the Australian Immunisation Register established and kept under the Australian Immunisation Register Act 2015.\n\nNCIRS means the National Centre for Immunisation Research and Surveillance (ABN 53 188 579 090).\n\nSAEFVIC means the Surveillance of Adverse Events Following Vaccination In the Community, funded by the Department of Health, Victoria.\n\nNote: SAEFVIC is comprised of two units at the following sites:\n\n(a) Murdoch Children’s Research Institute (Clinical) and\n\n(b) Monash Health & University (Epidemiology and Signal Investigation).\n\nTherapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.\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 tables in Part 1 and 2 of 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 is of a kind specified, under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.\n\n\n\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\nPart 1—NCIRS\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 about adverse events following immunisation with vaccines that relates to one or more of the following:(a) the aggregate numbers of AEMS reports;(b) the number of doses administered, as included in the AIR;(c) case narratives of individual AEMS reports;(d) case-line listed data, including (but not limited to) the:(i) number allocated to the adverse event by the TGA;(ii) date the adverse event was reported to the TGA;(iii) date of the onset of symptoms;(iv) sex of the patient;(v) age of the patient;(vi) reaction outcome;(vii) vaccine;(e) the TGA’s analysis of data provided by NCIRS or drawn from the AEMS and AIR databases;(f) methodologies and results of analysis pertaining to risk of adverse events following immunisation with vaccines the NCIRS to facilitate appropriate and effective analysis of data relating to safety signals associated with vaccines\n\n\n \n\nPart 2—SAEFVIC\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 about adverse events following immunisation with vaccines that is:(a) case details in relation to individual AEMS reports SAEFVIC to improve the monitoring of vaccine safety and facilitate appropriate and effective analysis of data relating to safety signals associated with vaccines\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not expand the statutory categories of therapeutic goods information; it specifies which adverse‑event information the Secretary may release and to which named bodies for safety monitoring and analysis, under subsection 61(5AA)/(5AB) (see s5 and Schedule 1). It therefore narrows operational release practice to named recipients and defined data fields rather than altering the Act’s underlying release power."},"complexity_factors":["Legal authorisation relies on specific subsections of the Therapeutic Goods Act (subsection 61(5AB) / 61(5AA)): users must map the instrument to statutory release powers (see s3 and s5).","Multiple named recipients with different permitted scopes: NCIRS (Part 1) and SAEFVIC (Part 2) each receive defined kinds of information (Schedule 1).","Data scope is detailed and technical: aggregate counts, AIR dose data, case narratives and line‑listed fields (including dates, age, sex, vaccine, outcomes) requiring careful handling and matching (Schedule 1, cols 2–4).","Operational dependency on two datasets/systems (AEMS and AIR) and TGA analysis functions creates integration and data‑quality considerations (definitions and s5).","Decision‑maker delegation and administrative action: instrument made by a delegate and contemplates Secretary/Delegate release decisions under the Act (instrument header, s3, s5).","Purpose‑limited release: each data share is tied to specified purposes (monitoring and analysis), requiring governance and compliance mechanisms to control secondary uses (s5, Schedule 1)."],"plain_english_summary":"This specification authorises the TGA (the Secretary or delegate) to release specified vaccine adverse‑event information from the Adverse Event Management System and the Australian Immunisation Register to two named bodies (NCIRS and SAEFVIC) for vaccine‑safety monitoring and analysis (s5, Schedule 1). It lists exact data types that may be shared — aggregate counts, doses, case narratives and line‑listed fields such as report dates, onset dates, age, sex, vaccine and outcomes — and limits use to the stated safety purposes."},"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":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: enabling data sharing for vaccine safety surveillance. It authorises exactly what the title suggests — analysis of adverse events following immunisation — and does not expand beyond this specific public health monitoring function."},"complexity_factors":["Very short instrument (approximately 2 pages of substantive content)","Only 6 defined terms in section 4, plus references to existing definitions in the parent Act","Simple structure: definitions, single operative section (section 5), and two tables in Schedule 1","No nested exceptions or conditional logic — just a straightforward 'may be released' framework","Minimal cross-referencing: only references to subsections 61(5AA) and 61(5AB) of the Therapeutic Goods Act 1989","Tabular format in Schedule 1 makes permissions clear and readable"],"plain_english_summary":"This instrument authorises the Secretary of the Department of Health to lawfully share specified vaccine safety data from TGA systems with NCIRS (national research centre) and SAEFVIC (Victoria’s surveillance unit). \n\nThat access lets expert researchers receive aggregated and case-level adverse‑event information to detect safety signals, monitor vaccine safety, and support immunisation research—enabling public‑health oversight that would otherwise be restricted by privacy and therapeutic‑goods laws."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022","history":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022/history","analysis":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022/analysis","conflicts":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022/important-cases","documents":"/api/acts/therapeutic-goods-analysis-of-adverse-events-following-immunisation-information-specification-2022/documents"}}