{"id":"F2023L00054","name":"Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 2023","slug":"therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441698,"registerId":"F2023L00054-fast-fetch-1775956936307","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 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 (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 2023\n\nI, Nicholas Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following determination.\n\nDated 24 January 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  Kind of information\n\n6  Form of information\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 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instrument 1 February 2023. 1 February 2023\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsections 26BD(8) and (9) 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\nTherapeutic Goods Administration means the part of the Department known as the Therapeutic Goods Administration.\n\n5  Kind of information\n\n  For the purposes of subparagraph 26BD(3)(e)(i) of the Act, an application for a recommendation by the Secretary that the Minister vary a section 26BB determination must be accompanied by information of the following kind:\n\n (a) the information specified in the document titled Mandatory requirements for an effective application to vary the Permissible Ingredients Determination (Version 1.0, February 2023), published by the Therapeutic Goods Administration, as in force or existing on 1 February 2023.\n\nNote: The document mentioned in paragraph (a) is published at www.tga.gov.au.\n\n6  Form of information\n\n  For the purposes of subparagraph 26BD(3)(e)(ii) of the Act, the information that must accompany an application for a recommendation by the Secretary that the Minister vary a section 26BB determination must be:\n\n (a) contained in an application dossier; and\n\n (b) in a form consistent with the document titled Mandatory requirements for an effective application to vary the Permissible Ingredients Determination (Version 1.0, February 2023), published by the Therapeutic Goods Administration, as in force or existing on 1 February 2023; and\n\n (c) in a form consistent with the document titled General dossier requirements (Version 1.4, July 2018) published by the Therapeutic Goods Administration, as in force or existing on 1 February 2023.\n\nNote: The documents mentioned in paragraphs (b) and (c) are published at www.tga.gov.au.\n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not change which variations to the Permissible Ingredients Determination may be sought. Instead it prescribes the information and dossier form that must accompany an application for the Secretary’s recommendation (see sections 5–6) under the existing Act powers (section 3; subsections 26BD(8) and (9)). It therefore alters procedural requirements and compliance burden, not the substantive scope of permitted variations."},"complexity_factors":["Cross-reference to the Therapeutic Goods Act 1989 (authority under subsections 26BD(8) and (9)) creates legal linkage beyond the instrument (section 3).","The instrument delegates substantive content to external TGA documents by reference (Mandatory requirements v1.0, Feb 2023; General dossier requirements v1.4, Jul 2018) rather than setting detail in‑text (sections 5(a), 6(b)–(c)).","Versioning/date specificity and 'as in force or existing on 1 February 2023' creates a fixed-reference point but requires users to retrieve the correct document versions.","Procedural prescription (must be an application dossier in a specified form) is simple in principle but imposes practical compliance steps on applicants (section 6).","Limited internal discretion: decision remains with the Secretary/Minister under the Act, but the instrument narrows acceptable application format which can affect administrative processing (sections 5–6)."],"plain_english_summary":"This instrument requires that any application asking the Secretary to recommend a variation to the Permissible Ingredients Determination must include specified information and be submitted as an application dossier that follows two TGA documents (see sections 5–6; subsections 26BD(3)(e)(i)-(ii)).\n\nIt affects sponsors/manufacturers who pay the preparation costs and must follow TGA templates; the Secretary (and ultimately the Minister) decide on the variation under the Act, so the rule changes application formality and compliance burden rather than the substantive grounds for variation (sections 5–6)."},"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":"This instrument performs exactly the narrow function its title suggests: specifying information requirements for applications to vary the Permissible Ingredients Determination. It has not expanded beyond this original purpose."},"complexity_factors":["Very short instrument — only 6 sections spanning 2 pages","Minimal defined terms — only 2 definitions in section 4 ('Act' and 'Therapeutic Goods Administration'), plus a reference to the Act's existing definitions","No nested exceptions or conditional logic — sections 5 and 6 contain straightforward 'must be accompanied by' requirements","Simple cross-referencing — only references to external TGA-published documents (which are incorporated by reference) and two subsections of the parent Act","Single purpose instrument — does one thing only (specify application requirements), with no branching provisions or alternative pathways"],"plain_english_summary":"This rule tells companies exactly what paperwork and formatting the Therapeutic Goods Administration (TGA) requires when applying to add or change ingredients on Australia’s Permissible Ingredients Determination for therapeutic goods.  \n\nIt affects pharmaceutical and complementary‑medicine manufacturers and the TGA, and matters because standardized, complete application dossiers — prepared to the TGA’s specified “Mandatory requirements” and “General dossier requirements” documents — speed consistent assessment and reduce risk of unsafe or poorly documented ingredients entering the market."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-","history":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-/history","analysis":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-/analysis","conflicts":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-/conflicts","importantCases":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-/important-cases","documents":"/api/acts/therapeutic-goods-permissible-ingredients-information-that-must-accompany-application-for-variation-/documents"}}