{"id":"F2017L00638","name":"Therapeutic Goods Information Specification 2017","slug":"therapeutic-goods-information-specification-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":96407,"registerId":"commonwealth-F2017L00638-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Information Specification 2017","content":"![](image.001.png)\n\nTherapeutic Goods Information Specification 2017\n\nTherapeutic Goods Act 1989\n\nI, Larry Kelly, a delegate of the Minister for Health, make this Specification under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\nDated 31st May 2017\n\n(Signed by)\n\nLARRY KELLY\n\nDelegate of the Minister for Health\n\n  \n\n1 Name of Specification\n\nThis Specification is the Therapeutic Goods Information Specification 2017.\n\n2 Commencement\n\nThis Specification commences on the day after it is registered.\n\n3 Repeal\n\nThis Specification repeals the Therapeutic Goods Information Specification 2015.\n\n4 Definitions\n\nIn this Specification:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> Register means the Australian Register of Therapeutic Goods.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> TGA means the Therapeutic Goods Administration which is part of the Department of Health.\n\n5 Therapeutic goods information\n\nThe kinds of therapeutic goods information in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.\n\n|     | Therapeutic Goods Information Specification 2017 | 1   |\n| --- | ------------------------------------------------ | --- |\n\n  \n\nSchedule 1 Specified kinds of therapeutic goods information\n\n(section 5)\n\nThe following kinds of therapeutic goods information:\n\nNote: The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act.\n\n    1 Product information approved by the Secretary under subsection 25AA(1) or 25AA(4) of the Act in relation to therapeutic goods.\n    2 Information required by regulation 9A or 9B of the Regulations to be supplied with certain therapeutic goods.\n    3 Information in documents prepared for the purpose of evaluating therapeutic goods under subsection 25(1) or subsection 9D(3) of the Act.\n    4 Information in relation to post-market pharmacovigilance requirements imposed by the Secretary under section 28 of the Act as a condition of registration on therapeutic goods or by a regulation made for the purposes of paragraph 28(5)(e) of the Act.\n    5 Information in documents relating to assessments made of the pharmacovigilance system, quality and non-clinical and clinical data in relation to therapeutic goods for the purpose of evaluating those goods under subsection 25(1) or subsection 9D(3) of the Act.\n    6 Information in documents included in a request of the Secretary to:\n\n    the Advisory Committee on Medicines (ACM) or its subcommittees or\n    the Advisory Committee on Vaccines (ACV),\n\n    seeking advice in relation to the evaluation of therapeutic goods under subsection 25(1) of the Act or subsection 9D(3) of the Act, including in relation to post-market pharmacovigilance requirements and the continued suitability for registration of therapeutic goods.\n    7 Information in the minutes or outcomes of ACM or its subcommittees, or ACV, about the evaluation of therapeutic goods under subsection 25(1) or subsection 9D(3) of the Act, including in relation to post-market pharmacovigilance requirements.\n    8 Information in the minutes or outcomes of any other expert committee established by the Regulations about the suitability for inclusion in the Australian Register of Therapeutic Goods of therapeutic goods the subject of an application for approval.\n    9 Information in any written decision made under subsection 25(3) of the Act in relation to the registration of therapeutic goods, including the reasons for the decision.\n    10 Information in any written decision under section 60 of the Act on a review of a decision under subsection 25(3), subsection 9D(3), or subsection 25AA(1) or 25AA(4), of the Act, in relation to therapeutic goods.\n\nNote\n\n1.  All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See [http://www.legislation.gov.au](http://www.legislation.gov.au)\n\n|     | Therapeutic Goods Information Specification 2017 | 3   |\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"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument repeals the Therapeutic Goods Information Specification 2015 (s.3) and restates the kinds of information specified under subsection 61(5D) for release under subsection 61(5C) (section 5; Schedule 1). From the text provided, it does not itself record an explicit expansion or narrowing of the listed categories beyond those in Schedule 1; determining substantive scope changes versus the 2015 Specification requires comparing the two instruments."},"complexity_factors":["Cross‑references to multiple Act provisions (subsections 25, 28, 60, 61) and Regulations (regs 9A, 9B) increase legal navigation (see Schedule 1 and section 5).","Administrative discretion: power to release information rests with the Secretary under s.61(5C)/(5D) (section 5; Schedule 1).","Enumerated categories: Schedule 1 lists ten distinct kinds of information, requiring classification of documents and possible redaction decisions.","Interplay with confidentiality and post‑market conditions: items include pharmacovigilance and evaluation data which may contain commercially sensitive material (Schedule 1, items 4–6).","Instrument-level change: repeals the 2015 Specification (s.3), requiring comparison to the prior instrument to determine substantive change.","Defined terms: reliance on defined terms (Act, Register, Regulations, TGA) requires cross‑checking institutional responsibilities (section 4)."],"plain_english_summary":"This Specification lists the kinds of therapeutic‑goods information the Secretary may publish under the Therapeutic Goods Act (see s.5 and Schedule 1). It repeals the 2015 Specification (s.3). \n\nWho decides: the Secretary/TGA. Who is affected: sponsors, manufacturers and applicants whose product information, evaluation documents, committee advice/minutes, post‑market pharmacovigilance conditions and written decisions may be disclosed. The measure clarifies which regulatory documents are liable to public release."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is a straightforward delegated legislative instrument that performs exactly the function intended by its enabling provision (section 61(5D) of the Therapeutic Goods Act 1989). It specifies categories of information for publication purposes without expanding beyond the transparency mandate of the parent Act. It replaces a 2015 version but maintains the same essential purpose."},"complexity_factors":["Very short document (3 pages, approximately 500 words)","Only 4 defined terms in section 4","Simple structure: definitions followed by a numbered list","No nested exceptions or conditional logic - just a straightforward list of 10 information categories","Minimal cross-referencing - only refers to specific subsections of the parent Act and Regulations to establish legal authority","No operative provisions creating obligations or offences - purely declaratory/specificatory in nature"],"plain_english_summary":"This Specification authorises the TGA to publish a defined “transparency list” of information about medicines, vaccines and medical devices — including product information, evaluation materials, committee advice, post‑market safety data and reasons for regulatory decisions. It affects patients, clinicians, researchers and sponsors by expanding public access to regulatory evidence and deliberations, replacing the 2015 version to increase openness about how therapeutic goods are assessed and monitored in Australia."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-specification-2017","history":"/api/acts/therapeutic-goods-information-specification-2017/history","analysis":"/api/acts/therapeutic-goods-information-specification-2017/analysis","conflicts":"/api/acts/therapeutic-goods-information-specification-2017/conflicts","importantCases":"/api/acts/therapeutic-goods-information-specification-2017/important-cases","documents":"/api/acts/therapeutic-goods-information-specification-2017/documents"}}