{"id":"F2025L00295","name":"Therapeutic Goods (Reportable Medicines) Determination 2025","slug":"therapeutic-goods-reportable-medicines-determination-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442775,"registerId":"F2025L00295-fast-fetch-1775957712972","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Reportable Medicines) Determination 2025","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 (Reportable Medicines) Determination 2025\n\nI, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following determination.\n\nDated  5 March 2025\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\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Reportable medicines\n\n6  Repeals\n\nSchedule 1—Reportable Medicines\n\nSchedule 2—Repeals\n\nTherapeutic Goods (Reportable Medicines) Determination 2018\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Reportable Medicines) Determination 2025.\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The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsection 30EH(2) 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) active ingredient;\n\n(b) current Poisons Standard;\n\n(c) medicine;\n\n(d) registered goods;\n\n(e) reportable medicine.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\n5  Reportable medicines\n\n  The medicines set out in Schedule 1, being medicines that are registered goods, are determined to be reportable medicines for the purposes of subparagraph 30EH(1)(b)(ii) of the Act.\n\n6  Repeals\n\n  Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.  \n\n\nSchedule 1—Reportable Medicines\n\nNote: See section 5.\n\n- Reportable Medicines\n- Column 1 Column 2\n- Item Medicine\n- 1 medicines that contain one of the following:(a) cyproheptadine;(b) levonorgestrel;(c) pancreatic extract;(d) theophylline;(e) ulipristal\n- 2 medicines that:(a) contain barium sulfate as an active ingredient; or(b) contain calcium gluconate, and are in the dosage form of an injection or a preparation for topical use; or(c) contain folinic acid (as calcium folinate) when included in Schedule 2 to the current Poisons Standard; or(d) contain glucagon, and are in the dosage form of an injection; or(e) contain glyceryl trinitrate, and are for sublingual use; or(f) contain hydroxocobalamin, and are in the dosage form of an injection; or(g) contain isosorbide dinitrate when included in Schedule 3 to the current Poisons Standard; or(h) contain magnesium sulfate as the only active ingredient, and are in the dosage form of an injection or an intravenous infusion; or(i) contain mannitol as an active ingredient, and are in the dosage form of a powder for inhalation; or(j) contain monobasic sodium phosphate as the only active ingredient; or(k) contain naloxone, and are in the dosage form of an injection or a nasal spray; or(l) contain salbutamol, and are in the dosage form of a preparation for inhalation; or(m) contain terbutaline, and are in the dosage form of a preparation for inhalation\n- 3 medicines for the treatment of anaphylaxis or management of cardiac arrest, that contain adrenaline (epinephrine) as the only active ingredient\n- 4 medicines that are in the dosage form of an injection and that contain one of the following as the only active ingredient:(a) phytomenadione;(b) sodium bicarbonate;(c) thiamine\n- 5 medicines for intravenous phosphate supplementation, that are in the dosage form of an injection or an infusion and that contain one of the following as an active ingredient:(a) dibasic potassium phosphate;(b) dibasic sodium phosphate;(c) monobasic potassium phosphate;(d) monobasic sodium phosphate\n- 6 medicines that contain 0.9% sodium chloride as the only active ingredient, and are in the dosage form of an injection or an intravenous infusion\n- 7 medicines for the treatment of poisonings, that are in the dosage form of an injection and that contain one of the following as an active ingredient:(a) ethanol;(b) sodium calcium edetate;(c) sodium nitrite;(d) sodium thiosulfate\n- 8 medicines for the treatment of poisonings or drug overdosage by oral ingestion, that contain activated charcoal as an active ingredient\n- 9 medicines for the treatment of scabies, that contain one of the following as an active ingredient:(a) benzyl benzoate;(b) permethrin\n- 10 medicines for oral bicarbonate supplementation, that contain sodium bicarbonate as an active ingredient\n\n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods (Reportable Medicines) Determination 2018\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"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":4,"scope_assessment":{"changed":true,"description":"This instrument expressly repeals the Therapeutic Goods (Reportable Medicines) Determination 2018 (Schedule 2) and substitutes the medicines listed in Schedule 1 as the reportable set. The instrument itself does not compare the old and new lists, so it is clear the listing has been changed but not whether the net scope is wider or narrower without a side‑by‑side comparison."},"complexity_factors":["Cross-reference to the Therapeutic Goods Act 1989 (subsection 30EH(1)(b)(ii)) — the instrument delegates effect to a statutory reporting regime (section 5).","Reliance on definitions located in the Act (subsection 3(1)) for terms like 'medicine', 'registered goods' and 'reportable medicine' (section 4).","Detailed conditional listings in Schedule 1 (specific active ingredients plus dosage‑form and Poisons Standard triggers) require product‑level analysis to identify covered products.","Multiple dosage‑form specifications (injection, infusion, inhalation, nasal spray, sublingual, topical) increase compliance checks for sponsors.","Cross-reference to the current Poisons Standard for some entries creates dependence on an external, updating instrument.","Repeal of the 2018 Determination (Schedule 2) means scope must be assessed by comparison with the prior list, which is not contained here.","Commencement tied to registration day creates a timing rule that affects when reporting obligations start (section 2)."],"plain_english_summary":"This instrument lists which registered medicines are \"reportable medicines\" under the Therapeutic Goods Act 1989 by naming specific active ingredients and setting dosage‑form conditions (Schedule 1). It applies to sponsors/registrants of those medicines because it makes those products subject to the Act’s reporting obligations and it repeals the 2018 Determination, replacing its list (Schedule 2)."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation maintains its original narrow purpose: specifying which medicines are subject to reporting requirements for loss or theft under section 30EH of the Therapeutic Goods Act 1989. The 2025 version updates the specific medicines listed compared to the 2018 version it repeals, but this is a routine technical update rather than an expansion of scope."},"complexity_factors":["Very short instrument (approximately 2 pages of substantive content)","Only 4 defined terms, with most definitions incorporated by reference to the parent Act","Simple structure: name, commencement, authority, definitions, operative provision, and two schedules","No nested conditional logic or exceptions to exceptions","Schedule 1 presents a straightforward list format with clear criteria (active ingredient + dosage form)","No cross-references to other legislation beyond the enabling Act and Poisons Standard","Single operative provision (section 5) that directly applies the Schedule 1 list"],"plain_english_summary":"This law requires certain important medicines to be reported to the Therapeutic Goods Administration if lost or stolen, updating the 2018 list with a 2025 replacement. It applies to hospitals, pharmacies, suppliers and other holders of those drugs and gives the TGA a mandatory feed of loss/theft reports.\n\nThe rule helps detect suspicious loss patterns, prevent diversion to illegal markets, and protect supply of life‑saving medicines for legitimate patients."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025","history":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025/history","analysis":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025/analysis","conflicts":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025/conflicts","importantCases":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025/important-cases","documents":"/api/acts/therapeutic-goods-reportable-medicines-determination-2025/documents"}}