{"id":"F2018L00641","name":"Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2018","slug":"f2018l00641","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":317940,"registerId":"commonwealth-F2018L00641-current","compilationNumber":null,"startDate":"2026-04-08","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is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 Registration) Determination 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 register a complementary medicine.","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: registered complementary medicines, version 8.0, published by the TGA in April 2018; and\n    (b) the information required by the document titled Mandatory requirements for an effective registered complementary medicines application, 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 1.3, published by the TGA in March 2018.\n\n> Note: The document mentioned in paragraph 6(b) is available on the TGA website (www.tga.gov.au).","sortOrder":5}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1096},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"The instrument maintains its original narrow administrative scope. It does exactly what the title suggests: specifies information requirements for complementary medicine registration applications without expanding into unrelated regulatory areas."},"complexity_factors":["Very short instrument (only 6 sections)","Only 3 defined terms","No conditional logic, exceptions, or nested provisions","Simple directive structure (applies to X, must do Y)","Minimal cross-referencing (only references parent Act and one related instrument)"],"plain_english_summary":"This determination sets out the paperwork requirements for companies applying to register complementary medicines (such as vitamins, herbal remedies, and traditional medicines) with Australia's Therapeutic Goods Administration (TGA).\n\n**What it requires:**\n- **Specific information**: Applications must include all details set out in two TGA guidance documents — \"CTD Module 1: registered complementary medicines\" and \"Mandatory requirements for an effective registered complementary medicines application\"\n- **Specific format**: All information must be compiled into an \"application dossier\" (a structured collection of documents) that follows the TGA's \"General dossier requirements\" document\n\n**Who it affects:**\n- Companies and manufacturers seeking to register complementary medicines in Australia\n- The TGA, which reviews these applications\n\n**Why it matters:**\nThe determination ensures every application contains the same essential safety and quality information, formatted consistently. This allows the TGA to efficiently assess whether a medicine meets the standards for registration."}},"importantCases":[],"_links":{"self":"/api/acts/f2018l00641","history":"/api/acts/f2018l00641/history","analysis":"/api/acts/f2018l00641/analysis","conflicts":"/api/acts/f2018l00641/conflicts","importantCases":"/api/acts/f2018l00641/important-cases","documents":"/api/acts/f2018l00641/documents"}}