{"id":"F2023L01025","name":"Therapeutic Goods (Prescription Medicines—Sharing of AusPARs) (Information) Specification 2023","slug":"therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442023,"registerId":"F2023L01025-fast-fetch-1775957155474","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Prescription Medicines—Sharing of AusPARs) (Information) Specification 2023","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 (Prescription Medicines—Sharing of AusPARs) (Information) Specification 2023\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 20     July 2023\n\nNicholas Henderson\n\nActing First Assistant Secretary  Medicines Regulation 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 Information about Prescription Medicines) Specification 2015\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Prescription Medicines—Sharing of AusPARs) (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 The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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) medicine;\n\n(c) product information;\n\n(d) Register;\n\n(e) registered goods;\n\n(f) Secretary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\napproved product information means the product information approved by the Secretary under section 25AA of the Act.\n\nAusPAR means the Australian Public Assessment Report for a prescription medicine, including the attached approved product information, that is published by the TGA.\n\nNote: AusPARs may also include the Clinical Evaluation Report, or an extract of the Clinical Evaluation Report, as an attachment. AusPARs are published on the TGA website at www.tga.gov.au.\n\nAustralian Prescriber means the journal published by Therapeutic Guidelines.\n\nregistered prescription medicine means a medicine that:\n\n (a) is included in the part of the Register for goods known as registered goods; and\n\n (b) would require a prescription from a health practitioner who is authorised to prescribe medicine under a law of a State or Territory.\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\nTherapeutic Guidelines means Therapeutic Guidelines Ltd (ABN 45 074 766 224).\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\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 about a registered prescription medicine that is contained in the AusPAR for the medicine Therapeutic Guidelines to facilitate the publication of the information specified in column 2 in Australian Prescriber soon after the publication of the AusPAR on the TGA website\n\n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods Information (Sharing of Information about Prescription Medicines) Specification 2015\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":2,"scope_assessment":{"changed":true,"description":"This instrument replaces the 2015 Specification (Schedule 2) and explicitly authorises release of AusPAR material to Therapeutic Guidelines for publication in Australian Prescriber, clarifying the authorised recipient and purpose (see s5, Schedule 1; Schedule 2)."},"complexity_factors":["Narrow subject-matter: authorises release only of AusPAR information for registered prescription medicines (Schedule 1).","Relies on delegated statutory power under subsection 61(5AB) of the Therapeutic Goods Act 1989 (Authority: s3; operation: s5).","Concentrated administrative discretion: the Secretary decides on releases permitted by this instrument (s5).","Defined-term dependencies: many key terms are drawn from the Act (notably subsection 3(1)) and the instrument's definitions (s4), so interpretation depends on the Act's definitions.","Low operational complexity: single listed recipient (Therapeutic Guidelines) and single purpose (publication in Australian Prescriber) reduce implementation steps (Schedule 1).","Repeal of prior instrument (Schedule 2) may require checking transitional arrangements or past practices for consistency (s6; Schedule 2).","Commencement is straightforward (the day after registration) but timing matters for publication workflows (s2)."],"plain_english_summary":"This specification authorises the TGA Secretary to release Australian Public Assessment Report (AusPAR) content for registered prescription medicines to Therapeutic Guidelines so it can be published in Australian Prescriber soon after the AusPAR appears on the TGA website (see s5, Schedule 1). It is made under subsection 61(5AB) of the Therapeutic Goods Act 1989, replaces a 2015 instrument, and centralises the decision to the Secretary; it primarily affects the TGA, Therapeutic Guidelines and readers of Australian Prescriber."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument maintains a narrow, focused scope consistent with its apparent original intent. It replaces the 2015 Specification with an updated version that continues the same basic function—authorising TGA to share AusPAR information with Therapeutic Guidelines for publication in Australian Prescriber. The scope has not expanded beyond this specific information-sharing mechanism."},"complexity_factors":["Very short instrument (approximately 2 pages of substantive content)","Only 6 operative sections, with 2 being purely mechanical (Name, Commencement)","Single table in Schedule 1 with only one row of actual regulatory substance","Minimal defined terms (only 6 definitions in section 4, plus references to existing Act definitions)","No nested exceptions, conditional logic, or cross-references beyond basic empowering provision","Straightforward repeal of single previous instrument in Schedule 2","Essentially a permission slip for one specific information-sharing arrangement"],"plain_english_summary":"This instrument lets the Therapeutic Goods Administration share Australian Public Assessment Reports (AusPARs) about prescription medicines with Therapeutic Guidelines Ltd so Australian Prescriber can publish them soon after the TGA posts them. \n\nIt affects the TGA, Therapeutic Guidelines, clinicians who rely on Australian Prescriber, and patients indirectly by speeding access to independent clinical and regulatory information that supports evidence-based prescribing."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023","history":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023/history","analysis":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023/analysis","conflicts":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023/conflicts","importantCases":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023/important-cases","documents":"/api/acts/therapeutic-goods-prescription-medicines-sharing-of-auspars-information-specification-2023/documents"}}