{"id":"F2018L01156","name":"Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination August 2018","slug":"therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97840,"registerId":"commonwealth-F2018L01156-current","compilationNumber":null,"startDate":"2026-04-02","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Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is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 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 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 1.4, 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":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1372},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument performs exactly as described in its title and purpose — specifying information requirements for complementary medicine registration applications — without expansion into unrelated regulatory areas."},"complexity_factors":["Only 3 defined terms in the interpretation section","6 short sections with straightforward structure","No conditional logic, exceptions, or cross-references to other legislation (beyond definitions)","Relies on incorporation by reference of 3 external TGA documents (practical complexity without legislative complexity)"],"plain_english_summary":"This determination acts as a **checklist for companies** applying to register complementary medicines in Australia (vitamins, herbal remedies, traditional medicines, etc.).\n\n**What it requires:**\n* **Specific documents:** Companies must submit two technical documents published by the Therapeutic Goods Administration (TGA) — \"CTD Module 1: registered complementary medicines\" and \"Mandatory requirements for an effective registered complementary medicines application\"\n* **Proper formatting:** All information must be organized into an \"application dossier\" (a structured collection of documents) that follows the TGA's \"General dossier requirements\" formatting rules\n\n**Why this matters:**\nWithout submitting this specific information in the correct format, the TGA can refuse to consider a registration application. This ensures the regulator receives consistent, complete information to assess whether products are safe, effective, and properly manufactured before they can be sold in Australia."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati","history":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati/history","analysis":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati/analysis","conflicts":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati/conflicts","importantCases":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati/important-cases","documents":"/api/acts/therapeutic-goods-complementary-medicines-information-that-must-accompany-application-for-registrati/documents"}}