{"id":"F2021L00234","name":"Therapeutic Goods (Adverse Events Following Immunisation) (Information) Specification 2021","slug":"therapeutic-goods-adverse-events-following-immunisation-information-specification-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440778,"registerId":"F2021L00234-fast-fetch-1775956292394","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Adverse Events Following Immunisation) (Information) Specification 2021","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 (Adverse Events Following Immunisation) (Information) Specification 2021\n\nI, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 12 March 2021\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\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\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Adverse Events Following Immunisation) (Information) Specification 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 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day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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) health practitioner;\n\n(b) Secretary;\n\n(c) State; and\n\n(d) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nAEFI means an adverse event that occurs in relation to a person in Australia following immunisation with a vaccine.\n\nJIC means a Jurisdictional Immunisation Coordinator for a State.\n\nNote: State is defined in section 3 of the Act as including the Australian Capital Territory and the Northern Territory.\n\nNCIRS means the National Centre for Immunisation Research and Surveillance (ABN 53 188 579 090).\n\nRegulations means the Therapeutic Goods Regulations 1990.\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\nTGA ADR report means an adverse drug reaction report made to the Therapeutic Goods Administration in relation to an adverse event associated with a vaccine.\n\nTGA means Therapeutic Goods Administration.\n\nTherapeutic Goods Administration has the same meaning as in the Regulations.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Release of therapeutic goods information\n\nFor subsection 61(5AA) of the Act, in relation to each item, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1, may be released to the persons or bodies specified in column 3, for the purposes specified in column 4 of the table.\n\nNote: Under subsection 61(5AA) of the Act, the Secretary may release to a person or body that is 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\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 relating to an AEFI, including the following:(a) the State in which the AEFI occurred;(b) the number allocated to the TGA ADR report for the AEFI by the TGA;(c) the name of the relevant vaccine;(d) the duration of the AEFI;(e) the age and gender of the relevant person;(f) a description of the AEFI;(g) a summary report of the AEFI;(h) other information, including clinical and non-clinical information, about the AEFI that is provided to the TGA by the person reporting the AEFI, a coroner or a health practitioner, and that relates to the TGA’s investigation of the AEFI the following persons or bodies:(a) JICs;(b) NCIRS;(c) SAEFVIC to ensure meaningful and effective participation in meetings on vaccine safety between the TGA, JICs, NCIRS and SAEFVIC to support the safety, quality and safe use of vaccines in Australia\n\n\n \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"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: specifying the release of AEFI information to specific bodies for vaccine safety meetings. There is no scope creep beyond this narrow information-sharing mechanism."},"complexity_factors":["Very short instrument (5 sections plus a single-table schedule)","Only 7 defined terms in section 4, plus references to existing definitions in the parent Act","Single operational provision (section 5) that simply cross-references a table","No nested conditions, exceptions, or procedural requirements","Single cross-reference to the Therapeutic Goods Act 1989 (subsection 61(5AB)) and Regulations","Straightforward tabular format in Schedule 1 with clear columns for information type, recipients, and purpose"],"plain_english_summary":"This law lets the TGA share specific details from adverse events following immunisation (AEFI) reports — like location, vaccine, age, gender, duration, description, and clinical notes — with Jurisdictional Immunisation Coordinators, NCIRS, and SAEFVIC.  \n\nSharing is limited to vaccine-safety meetings so these bodies can monitor and respond to safety signals quickly while constraining access and use to protect privacy."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument specifies (i.e. operationalises) the kinds of AEFI information and the named recipients to whom the Secretary may release information under subsection 61(5AA) of the Act. It does not amend the parent Act and contains no textual indication that it expands or narrows the Act’s statutory grant of power beyond listing the permitted data fields, recipients and purposes (s.3; s.5; Schedule 1)."},"complexity_factors":["Delegated legislative instrument that operates under subsection 61(5AB) of the Therapeutic Goods Act 1989 (s.3; s.5) — requires cross-checking with the parent Act for full legal effect.","Multiple defined terms and acronyms (AEFI, JIC, NCIRS, SAEFVIC, TGA) concentrated in the definitions section (s.4) and used in Schedule 1.","Prescribes specific personal and clinical data fields (State, TGA report number, vaccine name, duration, age, gender, description, summary, other clinical/non-clinical and coroner-supplied material) which raise data-handling and privacy considerations (Schedule 1, Item 1, col 2).","Narrowed list of authorised recipients (JICs, NCIRS, SAEFVIC) and stated purposes (participation in safety meetings; support vaccine safety, quality and safe use) create strict purpose-limitation but require operational definitions in practice (Schedule 1, cols 3–4).","Instrument is short and targeted, but relies on external bodies’ governance (TGA, State JICs, NCIRS, SAEFVIC) to implement secure information-sharing — implementation risk and compliance burden fall on those bodies (s.5; Schedule 1).","Includes coroner and health practitioner reports among permissible inputs to released information, which may complicate confidentiality and timing of releases (Schedule 1, Item 1, col 2(g)–(h)).","Commencement mechanics (instrument commences the day after registration) and delegate signature indicate executive discretion in effecting the specification (s.2; instrument header)."],"plain_english_summary":"This specification authorises the Secretary (through the TGA) to share defined adverse events following immunisation (AEFI) information — for example State, TGA report number, vaccine name, age, gender, event description, clinical details and coroner-reported material — with Jurisdictional Immunisation Coordinators (JICs), NCIRS and SAEFVIC. The stated purpose is to enable meaningful participation in vaccine-safety meetings and to support the safety, quality and safe use of vaccines in Australia."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021","history":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021/history","analysis":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021/analysis","conflicts":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021/important-cases","documents":"/api/acts/therapeutic-goods-adverse-events-following-immunisation-information-specification-2021/documents"}}