{"id":"F2023L00531","name":"Therapeutic Goods (Adverse Event Management System—Sponsors) (Information) Specification 2023","slug":"therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441855,"registerId":"F2023L00531-fast-fetch-1775957035984","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Adverse Event Management System—Sponsors) (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 (Adverse Event Management System—Sponsors) (Information) Specification 2023\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 5 May 2023\n\nNicholas Henderson\n\nActing First Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment 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\nSchedule 1—Therapeutic goods information\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Adverse Event Management System—Sponsors) (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of this instrument 12 May 2023. 12 May 2023\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 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) biological;\n\n(b) medicine;\n\n(c) Secretary;\n\n(d) sponsor.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nadverse event means an adverse event that occurs in relation to a person in Australia following the administration of a medicine or biological.\n\nNote: An adverse event may not necessarily have a causal relationship with the administration of the medicine or biological.\n\nAEMS means the Adverse Event Management System maintained by the Therapeutic Goods Administration.\n\nproduct name, for a medicine or biological, means either:\n\n (a) the commercial name:\n\n (i) given to the medicine or biological by the sponsor or manufacturer; and\n\n (ii) under which the medicine or biological is supplied; or\n\n (b) the name recorded in the AEMS for the medicine or biological by the Therapeutic Goods Administration.\n\nTherapeutic Goods Administration, or TGA, means the 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 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 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\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 de-identified information contained in an adverse event report in relation to a medicine or biological (the relevant goods) that is recorded in the AEMS, where the adverse event report includes the product name of the relevant goods the sponsor (and persons authorised to act on behalf of the sponsor) of the relevant goods to assist the sponsor in satisfying pharmacovigilance obligations under the Act, by facilitating access to, and effective analysis of, data relating to safety issues associated with the relevant goods, in order to ensure the safe use of those goods\n- 2 de-identified information contained in an adverse event report in relation to a medicine or biological that is recorded in the AEMS, where the adverse event report:(a) includes the active ingredient of the medicine or biological (the relevant active ingredient); and(b) does not include the product name of the medicine or biological a sponsor (and persons authorised to act on behalf of a sponsor) of a medicine or biological that contains the relevant active ingredient to assist the sponsor in satisfying pharmacovigilance obligations under the Act, by facilitating access to, and effective analysis of, data relating to safety issues associated with a medicine or biological that contains the relevant active ingredient, in order to ensure the safe use of those goods\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument sets out, as originally made, the specific kinds of AEMS-derived information that may be released and to whom (Schedule 1). No amendment or narrowing/widening of that scope is indicated in the instrument; commencement took effect 12 May 2023 (s2)."},"complexity_factors":["Reliance on cross-references to the Therapeutic Goods Act 1989 (authority under subsection 61(5AB) and permitted release under subsection 61(5AA))","De-identification requirement constrains usable data and raises practical privacy/identifiability judgments (Schedule 1, Items 1–2)","Two disclosure paths with different triggers: product-name-linked reports vs active-ingredient-linked reports without product name (Schedule 1, Items 1–2)","Discretion exercised by the Secretary/delegate in releasing information (Instrument made by delegate; s3 and s5)","Limited recipient class (sponsors and authorised agents) and single stated purpose—pharmacovigilance—restrict downstream uses (Schedule 1, column 3–4)","Operational dependence on the AEMS recordkeeping and matching logic (definitions of AEMS and product name in s4)"],"plain_english_summary":"This specification allows the TGA Secretary to share de-identified adverse event reports from the Adverse Event Management System (AEMS) with a sponsor (or persons authorised to act for a sponsor) of a medicine or biological, or with sponsors of products containing the same active ingredient, to help them meet pharmacovigilance obligations (s5, Schedule 1). Releases are authorised under the Therapeutic Goods Act 1989 and are limited to specified kinds of information and purposes (definitions and limits in Schedule 1)."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: specifying the circumstances under which therapeutic goods information about adverse events may be released to sponsors. It does not expand beyond the adverse event management context or create additional regulatory burdens beyond the information-sharing framework established by the parent Act."},"complexity_factors":["Very short instrument (approximately 2 pages)","Only 5 substantive sections plus a short schedule","Minimal defined terms (4 definitions in section 4, plus references to existing Act definitions)","Simple conditional structure: single operative provision (section 5) with cross-reference to a table","No nested exceptions or complex logical operators","Straightforward purpose: authorising release of specific information to specific parties for specific purposes","Schedule 1 contains only 2 items in a simple table format with 4 columns"],"plain_english_summary":"This instrument lets the TGA share de-identified adverse event reports from its AEMS with product sponsors, so companies whose brand or active ingredient appears in a report can access relevant safety data. \n\nIt affects sponsors, the TGA, and indirectly patients and healthcare providers by improving pharmacovigilance—helping identify risks and prompt safety actions—while protecting individual privacy through de-identification."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023","history":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023/history","analysis":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023/analysis","conflicts":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023/conflicts","importantCases":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023/important-cases","documents":"/api/acts/therapeutic-goods-adverse-event-management-system-sponsors-information-specification-2023/documents"}}