{"id":"F2018L01679","name":"Therapeutic Goods (Medicines Watch List) Determination 2018","slug":"therapeutic-goods-medicines-watch-list-determination-2018","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98323,"registerId":"commonwealth-F2018L01679-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Medicines Watch List) Determination 2018.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 30EJ(1) of the Act.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 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(b) reportable medicine.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nIV or intravenous, in relation to a medicine, means the route of administration that is delivered within or into a vein.\n\nml means millilitre.\n\nmmol means millimole.\n\nPO or per oral, in relation to a medicine, means the route of administration that is taken through the mouth into the gastrointestinal system or administered to the oral cavity to obtain a local or systemic effect.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Medicines Watch List","content":"#### 5 Medicines Watch List\n\nThe medicines set out in Schedule 1, being reportable medicines, are determined for the purposes of subsections 30EF(2) and 30EG(2) of the Act.\n\n \n\nSchedule 1—Medicines Watch List\n\n(section 5)\n\n| Column 1Item | Column 2Medicine |\n| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1 | medicines that contain any of the following antimicrobial agents:(a) aciclovir IV(b) amikacin(c) amphotericin B IV (liposomal)(d) ampicillin(e) benzylpenicillin(f) cefepime(g) chloramphenicol IV(h) ciprofloxacin IV(i) colistin(j) ethambutol(k) ganciclovir(l) gentamicin IV(m) isoniazid(n) metronidazole IV(o) phenoxymethylpenicillin(p) piperacillin and tazobactam(q) rifampicin PO or IV(r) sodium fusidate PO or IV(s) trimethoprim and sulfamethoxazole IV(t) vancomycin(u) voriconazole IV |\n| 2 | medicines that are, or contain, any of the following antidotes or treatments for poisonings:(a) activated charcoal(b) desferrioxamine injection(c) digoxin specific antibodies(d) edetate calcium disodium injection(e) ethanol injection(f) folinic acid (calcium folinate) injection(g) fomepizole(h) methylene blue IV(i) n-acetylcysteine IV(j) pralidoxime(k) sodium nitrite IV(l) sodium thiosulfate IV |\n| 3 | medicines for emergency or critical care that contain any of the following:(a) adrenaline IV(b) alteplase(c) amiodarone IV(d) argipressin (vasopressin)(e) calcium gluconate gel(f) calcium gluconate injection(g) cyproheptadine(h) danaparoid(i) dantrolene injection(j) desmopressin IV(k) dexamethasone IV(l) diazepam IV(m) glucagon injection(n) glyceryl trinitrate IV(o) hydralazine IV(p) hydrocortisone IV(q) isoprenaline(r) mesna(s) morphine IV(t) methoxyflurane(u) metoprolol IV(v) neostigmine(w) nimodipine PO or IV(x) noradrenaline(y) phenytoin IV(z) phosphate IV(za) prednisolone PO(zb) protamine(zc) pyridostigmine(zd) quinine injection(ze) rasburicase(zf) salbutamol IV(zg) sodium bicarbonate 100mmol per 100ml injection(zh) sodium polystyrene sulfonate(zi) suxamethonium(zj) terlipressin(zk) tenecteplase(zl) thiamine IV(zm) vitamin K (phytomenadione) IV |\n| 4 | medicines that contain any of the following anticoagulants:(a) enoxaparin(b) heparin(c) warfarin |\n| 5 | medicines that are any of the following vaccines:(a) a vaccine included in the National Immunisation Program Schedule, as in force or existing at 1 March 2025(b) absorbed diphtheria tetanus vaccine(c) bacillus calmette-guerin vaccine |\n| 6 | medicines for use in obstetrics that contain any of the following:(a) ergometrine(b) magnesium sulfate IV(c) misoprostol |\n| 7 | medicines that are any of the following antivenoms:(a) black snake antivenom(b) box jellyfish antivenom(c) brown snake antivenom(d) death adder antivenom(e) funnel web spider antivenom(f) polyvalent snake antivenom(g) red back spider antivenom(h) sea snake antivenom(i) stone fish antivenom(j) taipan antivenom(k) tiger snake antivenom |\n| 8 | medicines that are any of the following:(a) adrenaline autoinjector(b) glyceryl trinitrate sublingual(c) naloxone injection(d) naloxone nasal spray(e) salbutamol inhaler |","sortOrder":3}],"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 designates particular medicines as reportable under the Act; it does not amend the Act or on its face expand the statutory powers. It confines scope by listing specific products and formulations to be treated as reportable for the cited subsections, rather than changing the underlying reporting framework."},"complexity_factors":["Long, detailed Schedule listing many specific medicines and formulations (technical pharmaceutical terminology).","Cross-references to multiple provisions of the Therapeutic Goods Act 1989 (s30EJ(1), s30EF(2), s30EG(2)) requiring users to read the Act to determine practical effects.","Inclusion of routes and dosages (IV, PO, volumes, mmol) that require clinical interpretation for scope determinations.","Temporal reference to an external timetable: National Immunisation Program Schedule as in force at 1 March 2025 (requires updating cross-checks).","Mixed categories (antimicrobials, antidotes, emergency drugs, anticoagulants, vaccines, obstetric drugs, antivenoms, auto-injectors) increasing stakeholder diversity and varied compliance burdens."],"plain_english_summary":"This instrument, made under s30EJ(1) of the Therapeutic Goods Act 1989, designates the medicines listed in Schedule 1 as “reportable medicines” for the purposes of subsections 30EF(2) and 30EG(2) of the Act. It does not itself set out reporting steps but fixes which products attract the Act’s reporting/monitoring regime. \n\nThat designation changes the legal status of those listed medicines and therefore affects suppliers, sponsors and health services by creating additional compliance, record‑keeping and stock-management considerations tied to the reporting rules in the cited Act provisions."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument performs exactly the function indicated by its title — establishing a Medicines Watch List. It has not expanded beyond this single purpose."},"complexity_factors":["Very short instrument — only 5 substantive sections plus a schedule","Minimal defined terms (only 4: Act, IV/intravenous, ml, mmol, PO/per oral)","No cross-references to other legislation beyond the enabling Act","Simple tabular format for the medicines list with no conditional logic or exceptions","Straightforward declaratory structure: 'The medicines set out in Schedule 1... are determined'","No operative provisions creating obligations — merely establishes a list for reference by other provisions in the parent Act"],"plain_english_summary":"This creates a Medicines Watch List under the Therapeutic Goods Act, designating certain medicines as \"reportable\" and requiring manufacturers and suppliers to notify authorities of shortages or supply issues. It directly affects pharmaceutical companies, suppliers, hospitals, pharmacies and other healthcare providers, and indirectly protects patients.\n\nThe list targets high‑risk categories—antibiotics/antivirals, antidotes, emergency and critical‑care drugs, blood thinners, vaccines, obstetric medicines, antivenoms and emergency rescue medicines—so regulators can act quickly to prevent harmful shortages."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018","history":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018/history","analysis":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018/analysis","conflicts":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018/conflicts","importantCases":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018/important-cases","documents":"/api/acts/therapeutic-goods-medicines-watch-list-determination-2018/documents"}}