{"id":"F2022L01601","name":"Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2022","slug":"f2022l01601","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441639,"registerId":"F2022L01601-fast-fetch-1775956899888","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2022","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 (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2022\n\nI, Nicholas Henderson, as delegate of the Secretary of the Department of Health and Aged Care, make the following determination.\n\nDated 8 December 2022\n\nNicholas Henderson\n\nActing First Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health and Aged Care\n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Application\n\n6  Kind of information\n\n7  Form of information\n\n8  Repeals\n\nSchedule 1—Repeals\n\nTherapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination August 2018\n\n1  Name\n\n  This instrument is the Therapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination 2022.\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 The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 23B(9) and (10) 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) medicine.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\ncomplementary medicine has the same meaning as in the Regulations.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nTherapeutic Goods Administration has the same meaning as in the Regulations.\n\n5  Application\n\n  This instrument applies to medicines of the class specified in paragraph 4(1)(b) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018, as in force or existing at the commencement of this instrument.\n\nNote: The Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018 is a notifiable instrument and is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au/).\n\n6  Kind of information\n\n  For the purposes of subparagraph 23B(2)(d)(i) of the Act, an application for the registration of a complementary medicine must be accompanied by information of the following kind:\n\n (a) the information specified for the medicine in the document titled CTD Module 1: Administrative information for registered complementary medicines, Australian regulatory guidance (version 1.0, May 2020) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument; and\n\n (b) the information specified for the medicine in the document titled Mandatory requirements for an effective registered complementary medicine application, for applications lodged from March 2018 (version 1.1, July 2021) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\nNote: The documents mentioned in paragraphs (a) and (b) are published at www.tga.gov.au.\n\n7  Form of information\n\n  For the purposes of subparagraph 23B(2)(d)(ii) of the Act, the information that accompanies an application for the registration of a complementary medicine must be:\n\n (a) contained in an application dossier; and\n\n (b) 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 at the commencement of this instrument.\n\nNote: The document mentioned in paragraph (b) is published at www.tga.gov.au.\n\n8  Repeals\n\n  Each instrument that is specified in Schedule 1 is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Repeals\n\nNote: See section 8.\n\nTherapeutic Goods (Complementary Medicines—Information that Must Accompany Application for Registration) Determination August 2018\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument repeals the 2018 Determination and restates documentary and formatting requirements for complementary-medicine registration applications, pointing to specific TGA guidance versions. It continues to apply to the same class of medicines (complementary medicines) and does not, on its face, expand the statutory scope of what products are covered; the change is primarily procedural and updates the references to current guidance."},"complexity_factors":["Short instrument but heavily dependent on external TGA guidance documents (CTD Module 1; Mandatory requirements; General dossier requirements) whose content determines substantive requirements","Cross-references to other instruments and statutory definitions (Therapeutic Goods Act 1989; Classes instrument 2018; Regulations) increase the reader’s need to consult multiple sources","Specified versions and the phrase “as in force or existing at the commencement” create potential ambiguity about future updates and version control","Repeal of a prior instrument (2018 Determination) requires comparison to earlier text to determine practical changes","Administrative and procedural requirements (dossier form, mandatory items) create operational compliance burden for applicants"],"plain_english_summary":"This Determination requires anyone applying to register a complementary medicine to supply particular information from TGA guidance documents and to lodge it as an application dossier in the TGA’s prescribed format. It applies to products classed as complementary medicines and replaces the 2018 Determination. It matters because sponsors (manufacturers/importers) bear the cost and work of compiling those documents to the specified form, and the TGA uses that dossier to decide whether the product can be registered."},"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":"The legislation maintains its original narrow purpose: specifying application requirements for complementary medicine registration. The 2022 version is a straightforward update replacing the 2018 version to reference current TGA guidance documents, without expanding beyond this specific administrative function."},"complexity_factors":["Very short instrument (only 8 sections plus a single-item repeal schedule)","Minimal defined terms (only 4 definitions in section 4, plus references to Act definitions)","No nested exceptions or conditional logic — requirements are straightforward 'must be accompanied by' statements","Simple structure: definitions → application → substantive requirements → repeal","Heavy reliance on external documents (incorporates 3 TGA guidance documents by reference), which adds practical complexity for applicants but keeps the legislative text simple"],"plain_english_summary":"This law sets the paperwork rules for registering complementary medicines in Australia: sponsors must submit a standardized \"application dossier\" and follow two specific TGA guidance documents listing required evidence. It governs what companies must provide and how the TGA reviews those submissions, ensuring consistent, assessable standards for safety, quality and efficacy. The 2022 version replaces the 2018 determination to align with current TGA guidance."}},"importantCases":[],"_links":{"self":"/api/acts/f2022l01601","history":"/api/acts/f2022l01601/history","analysis":"/api/acts/f2022l01601/analysis","conflicts":"/api/acts/f2022l01601/conflicts","importantCases":"/api/acts/f2022l01601/important-cases","documents":"/api/acts/f2022l01601/documents"}}