{"id":"F2018L01154","name":"Therapeutic Goods (OTC Medicines—Information that Must Accompany Application for Registration) Determination August 2018","slug":"therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97835,"registerId":"commonwealth-F2018L01154-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 (OTC 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> TGA means the part of the Department of Health known as the Therapeutic Goods Administration.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Therapeutic goods to which this instrument applies","content":"#### 4 Therapeutic goods to which this instrument applies\n\n  This instrument applies to medicines of the kind specified in paragraph 4(1)(c) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.","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 specified in the document titled Common Technical Document Module 1: OTC Medicines, version 1.2, published by the TGA in June 2017; and\n    (b) the information required by the document titled Mandatory requirements for an effective over-the-counter medicines application, version 1.1, published by the TGA in March 2016.\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":"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"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument does not alter which goods fall within scope; it prescribes the information and dossier form required for registration applications for OTC medicines defined elsewhere (paragraph 4(1)(c) of the Classes Instrument 2018). There is no text in this instrument that expands or narrows the class definition itself."},"complexity_factors":["Instrument is short but relies on multiple external TGA documents by specific version numbers (v1.2, v1.1, v1.4), requiring applicants to consult those sources.","Scope is defined by cross‑reference to another instrument (paragraph 4(1)(c) of the Classes Instrument 2018), which requires look‑ups to determine applicability.","Legal effect is procedural and delegated (specifies content and form) rather than substantive, so practical compliance depends on non‑legislative guidance details.","References to subsections 23B(9) and 23B(10) of the Act create dependency on statutory provisions for interpretation and enforcement.","Version‑specific citations create potential for confusion if TGA updates guidance (tracking and applying correct versions is a compliance task)."],"plain_english_summary":"This Determination tells applicants what information and file format must accompany registration applications for certain over‑the‑counter (OTC) medicines under the Therapeutic Goods Act. It applies to the medicines listed in paragraph 4(1)(c) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018.\n\nApplicants must supply the content set out in the TGA's Common Technical Document Module 1: OTC Medicines (v1.2) and the Mandatory requirements for an effective over‑the‑counter medicines application (v1.1), and lodge them as an application dossier consistent with the TGA's General dossier requirements (v1.4). This creates a documentation and formatting compliance obligation for applicants."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: specifying documentation requirements for OTC medicine registration applications. It has not expanded beyond this narrow administrative function."},"complexity_factors":["Only 6 short sections total","Just 2 defined terms ('Act' and 'TGA')","No nested exceptions or conditional logic","Minimal cross-referencing — only refers to one other legislative instrument (the Classes of Therapeutic Goods Instrument 2018) and three external TGA documents","Straightforward structure: name, commencement, definitions, scope, then two substantive requirements (what information, and in what form)"],"plain_english_summary":"This law requires companies seeking to register over‑the‑counter (OTC) medicines in Australia to submit specific paperwork and technical information to the Therapeutic Goods Administration (TGA) and to follow TGA‑published guidance on dossier content and formatting. \n\nIt affects pharmaceutical sponsors and the TGA by standardising applications, ensuring necessary safety and quality data are provided up front, and reducing delays from incomplete submissions."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi","history":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi/history","analysis":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi/analysis","conflicts":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi/conflicts","importantCases":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi/important-cases","documents":"/api/acts/therapeutic-goods-otc-medicines-information-that-must-accompany-application-for-registration-determi/documents"}}