{"id":"F2024L01211","name":"Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024","slug":"therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442591,"registerId":"F2024L01211-fast-fetch-1775957561905","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\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 (Standard for Export Only Medicines) (TGO 114) Order 2024\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following order.\n\nDated 25 September 2024\n\nNicholas Henderson\n\nFirst Assistant Secretary  Medicines Regulation Division  Health Products Regulation Group  Department of Health and Aged Care\n\n \n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Standard\n\n6  Application\n\n7  Requirements\n\n8  Repeals\n\nSchedule 1—Repeals\n\nTherapeutic Goods Order No. 70C – Standards for Export Only Medicine\n\n \n\n \n\n1  Name\n\n (1) This instrument is the Therapeutic Goods (Standard for Export Only Medicines) (TGO 114) Order 2024.\n\n (2) This instrument may also be cited as TGO 114.\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 30 September 2024. 30 September 2024\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 section 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) British Pharmacopoeia;\n\n(b) European Pharmacopoeia;\n\n(c) export only medicine;\n\n(d) standard;\n\n(e) United States Pharmacopoeia-National Formulary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nJapanese Pharmacopoeia means the English edition of the publication of that name, published by the Japanese Pharmaceuticals and Medical Devices Agency or any replacement body, as in force or existing from time to time.\n\n5  Standard\n\n  The matters specified in this instrument constitute a standard for export only medicines.\n\n6  Application\n\n (1) This instrument applies to export only medicines.\n\n (2) For the avoidance of doubt, and subject to section 13 of the Act, this instrument applies in addition to any other instruments made under section 10 of the Act that apply to export only medicines.\n\n7  Requirements\n\n  An export only medicine must:\n\n (a) comply with the requirements specified in the applicable individual, specific and general monographs in at least one of the following pharmacopoeia, as interpreted in accordance with the General Notices section of the relevant pharmacopoeia:\n\n (i) the British Pharmacopoeia;\n\n (ii) the European Pharmacopoeia;\n\n (iii) the Japanese Pharmacopoeia;\n\n (iv) the United States Pharmacopoeia-National Formulary; and\n\n (b) where the export only medicine is not regulated as a medicine in the country to which it is to be exported—meet the regulatory requirements of the country to which it is to be exported.\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\nTherapeutic Goods Order No. 70C – Standards for Export Only Medicine\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument applies to export only medicines (s6) and repeals the prior Therapeutic Goods Order No. 70C (s8, Schedule 1). The text itself does not state an expansion or narrowing of scope compared with the repealed instrument; any substantive change in coverage or requirements cannot be identified from this instrument alone without side‑by‑side comparison to the repealed instrument."},"complexity_factors":["Short, focused instrument with few provisions reduces legal complexity","Incorporation by reference to external pharmacopoeias (British, European, Japanese, US) requires cross‑referencing those texts (s7(a))","Interpretation depends on each pharmacopoeia’s General Notices, creating dependence on non‑legislative source rules (s7(a))","Obligation to meet importing country requirements where the product is not regulated there introduces cross‑jurisdictional compliance obligations and factual enquiries (s7(b))","Definitions rely on the Act and external publications (s4), so users must consult multiple documents to determine scope and meaning","Repeal of the prior instrument (TGO 70C) means practitioners must compare instruments externally to identify any substantive drafting differences (s8, Schedule 1)"],"plain_english_summary":"This Order sets the quality standard that applies to medicines made in Australia for export only. It requires exporters to meet the individual, specific and general monographs in one of four listed pharmacopoeias (British, European, Japanese or US), interpreted under each pharmacopoeia’s General Notices, and to satisfy the importing country’s regulatory requirements where the product is not regulated there. It affects manufacturers and exporters by fixing which recognised pharmacopoeial tests and specifications govern export‑only products and by allocating testing, documentation and compliance costs to those parties."},"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 scope. It replaces the previous TGO 70C with essentially the same purpose: setting standards for export-only medicines. The requirements remain functionally identical (compliance with major pharmacopoeias and destination country rules). No expansion of scope is evident."},"complexity_factors":["Very short instrument (approximately 1.5 pages of substantive content)","Only 1 defined term ('Japanese Pharmacopoeia') — other terms rely on existing definitions in the parent Act","Simple structure: name, commencement, authority, definitions, standard declaration, application, requirements, repeals","Single operative requirement in section 7 with two straightforward limbs (pharmacopoeia compliance OR destination country requirements)","No nested exceptions, cross-references to other instruments (beyond general reference to other section 10 instruments), or conditional logic","Repeal schedule is a single item replacing one previous instrument"],"plain_english_summary":"This Order sets binding quality standards for Australian-made medicines destined only for export, requiring they meet at least one major international pharmacopoeia (British, European, Japanese, or US) and also satisfy the buyer country’s regulatory or non-medicine requirements. Replacing the prior standard from 30 September 2024, it affects Australian exporters, overseas importers, and the TGA — preserving Australia’s pharmaceutical reputation and preventing substandard “Made in Australia” exports."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024","history":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024/history","analysis":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024/analysis","conflicts":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024/conflicts","importantCases":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024/important-cases","documents":"/api/acts/therapeutic-goods-standard-for-export-only-medicines-tgo-114-order-2024/documents"}}