{"id":"F2018L01155","name":"Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018","slug":"therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97838,"registerId":"commonwealth-F2018L01155-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Section 26AE Listing) Determination August 2018.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n  This instrument commences on the day after it is registered.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Definitions","content":"#### 3 Definitions\n\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> complementary medicine means a medicine of the kind specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.\n\n> TGA means the part of the Department of Health known as the Therapeutic Goods Administration.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Applications to which this instrument applies","content":"#### 4 Applications to which this instrument applies\n\n  This instrument applies to an application to list a complementary medicine under section 26AE of the Act.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Kind of information","content":"#### 5 Kind of information\n\n  For the purposes of subsection 23B(9) of the Act, the application must be accompanied by:\n    (a) the information required by the document titled CTD Module 1: Administrative information for assessed listed medicines, version 1, published by the TGA in March 2018; and\n    (b) the information required by the document titled Mandatory requirements for an assessed listed medicine application to pass preliminary assessment, version 1, published by the TGA in March 2018.\n\n> Note: The documents mentioned in section 5 are available on the TGA website (www.tga.gov.au).","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Form of information","content":"#### 6 Form of information\n\n  For the purposes of subsection 23B(10) of the Act, the information must be :\n    (a) contained in an application dossier; and\n    (b) in a form consistent with the document titled General dossier requirements, version 1.4, published by the TGA in July 2018.\n\n> Note: The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).","sortOrder":5}],"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":3,"scope_assessment":{"changed":false,"description":"The instrument does not expand which goods are subject to listing or create new powers. It prescribes the information items and the form applicants must provide when seeking a section 26AE listing of a complementary medicine, thereby standardising submission requirements (see ss4–6 and s3 definitions)."},"complexity_factors":["Dependence on external TGA documents by title and version (requires applicants to use CTD Module 1 and Mandatory requirements, ss5(a)–(b))","Specified dossier format requirement referencing a separate TGA guidance document (ss6(a)–(b)), so compliance depends on interpreting that guidance","Cross-references to the Act (subsections 23B(9) and 23B(10)) and a separate instrument for the definition of 'complementary medicine' (s3), adding legal linkage","Administrative burden concentrated on sponsors/manufacturers to compile, organise and version-control the required dossier (ss5–6)","Operational reliance on the TGA to accept and assess dossiers under the Act (definition of TGA in s3 and instrument application in s4) — procedural rather than substantive change"],"plain_english_summary":"This instrument requires applications to list a complementary medicine under section 26AE to include two specified TGA documents (CTD Module 1 and Mandatory requirements for assessed listed medicines) and to submit them as a dossier formatted to the TGA's General dossier requirements v1.4. It affects sponsors/manufacturers who apply to list complementary medicines: they must prepare and format prescribed materials for TGA assessment (see sections 4–6). The change standardises submission content and form, imposing a compliance task on applicants."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument performs exactly the narrow, technical function its title suggests: specifying application requirements for complementary medicine listings. It has not expanded beyond this original purpose."},"complexity_factors":["Only 6 short sections total","Just 3 defined terms in the interpretation section","No nested exceptions or conditional logic","Minimal cross-referencing (only references to external TGA guidance documents and one section of the parent Act)","Straightforward structure: name, commencement, definitions, application scope, then two substantive requirements (content and format)"],"plain_english_summary":"This instrument prescribes the paperwork companies must submit to list complementary medicines on the Australian Register of Therapeutic Goods, requiring applicants to follow two TGA guidance documents for content and one for format. It affects manufacturers and importers seeking ARTG listing and the TGA that processes applications. By making correct, consistent submissions mandatory, it prevents incomplete applications from being accepted and helps speed and standardise the approval process while protecting consumers."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26","history":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26/history","analysis":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26/analysis","conflicts":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26/conflicts","importantCases":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26/important-cases","documents":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-section-26/documents"}}