{"id":"F2022L01758","name":"Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022","slug":"therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441689,"registerId":"F2022L01758-fast-fetch-1775956932034","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listed Medicines—Conditions of Listing) 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 (Listed Medicines—Conditions of Listing) Determination 2022\n\nI, Cheryl McRae, as delegate of the Minister for Health and Aged Care, make the following determination.\n\nDated 13 December 2022\n\nDr Cheryl McRae\n\nAssistant Secretary\n\nComplementary and Over the Counter Medicines Branch\n\nHealth Products Regulation Group\n\nDepartment 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  Conditions of listing\n\nSchedule 1—Conditions of listing\n\nPart 1—Specified listed medicines\n\nPart 2—Specified listed medicines that are sunscreens\n\nPart 3—Specified listed medicines that may contain aristolochic acids\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Listed Medicines—Conditions of Listing) 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The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsection 28(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) batch;\n\n(b) export only medicine;\n\n(c) manufacture;\n\n(d) medicine;\n\n(e) Register;\n\n(f) supply.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant person, in relation to a medicine, means the person in relation to whom the medicine is listed in the Register.\n\nspecified listed medicines means medicines that are listed in the Register under section 26A or 26AE of the Act.\n\nNote: Specified listed medicines do not include export only medicines, which are listed under section 26 of the Act.\n\nTherapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.\n\n5  Conditions of listing\n\nSpecified listed medicines\n\n (1) For the purposes of subsection 28(1) of the Act, the conditions set out in the table in Part 1 of Schedule 1 are determined to be conditions to which the listing of the following goods is subject:\n\n (a) specified listed medicines.\n\nSpecified listed medicines that are sunscreen preparations\n\n (2) For the purposes of subsection 28(1) of the Act, the conditions set out in the table in Part 2 of Schedule 1 are determined to be conditions to which the listing of the following goods is subject:\n\n (a) specified listed medicines mentioned in item 7 of the table in Schedule 4 to the Regulations.\n\nSpecified listed medicines that may contain aristolochic acids\n\n (3) For the purposes of subsection 28(1) of the Act, the conditions set out in the table in Part 3 of Schedule 1 are determined to be conditions to which the listing of the following goods is subject:\n\n (a) specified listed medicines that contain, or may contain, one or more of the following ingredients:\n\n (i) Anamirta cocculus;\n\n (ii) Asarum europaeum;\n\n (iii) Asarum heterotropoides;\n\n (iv) asarum oil;\n\n (v) Asarum sieboldii;\n\n (vi) Clematis armandii;\n\n (vii) Clematis chinensis;\n\n (viii) Clematis recta;\n\n (ix) Clematis vitalba;\n\n (x) Cocculus orbiculatus;\n\n (xi) costus root oil;\n\n (xii) Menispermum canadense;\n\n (xiii) Saussurea costus;\n\n (xiv) Sinomenium actutum;\n\n (xv) Stephania tetranda.\n\nSchedule 1—Conditions of listing\n\nNote: See section 5\n\nPart 1—Specified listed medicines\n\n- Conditions applicable to specified listed medicines\n- Column 1 Column 2\n- Item Conditions\n- 1 The relevant person must keep records relating to the medicine that are necessary to:(a) expedite recall, if necessary, of a batch of the medicine; and(b) identify the manufacturer of each batch of the medicine.\n- 2 Where any step in the manufacture of the medicine in Australia is sub‑contracted to a third party, the relevant person must keep copies of relevant Good Manufacturing Practice agreements in relation to that manufacture.\n- 3 The relevant person must:(a) retain records of the distribution of the medicine for a period of five years; and(b) upon request, provide the records (or copies of the records) to the TGA.\n- 4 The relevant person must notify the TGA of any product recall or other regulatory action taken in relation to the medicine outside Australia, which is or may be relevant to the quality, safety or efficacy of the medicine supplied in Australia, as soon as reasonably practicable after the relevant person becomes aware of the product recall or other regulatory action.\n\n\n\n\n\nPart 2—Specified listed medicines that are sunscreens\n\n- Conditions applicable to sunscreens\n- Column 1 Column 2\n- Item Conditions\n- 1 Where testing conducted by AMA Laboratories Inc. is used to substantiate compliance of the medicine with paragraphs (a) and (b) of item 7 of the table in Schedule 4 to the Regulations, the relevant person must:(a) hold one of the following to scientifically justify the validity and accuracy of the SPF, broad spectrum and water resistance claims for the medicine:(i) adequate supplementary in-vitro testing data; or(ii) relevant testing data from an independent testing laboratory on a comparable formulation; or(iii) other justification acceptable to the TGA; and(b) provide the information mentioned in paragraph (a) to the TGA within 10 working days of a request by the TGA, or within such other longer period as is agreed with the TGA.\n\n\n\n\n\nPart 3—Specified listed medicines that may contain aristolochic acids\n\n- Conditions applicable to specified listed medicines that may contain aristolochic acid\n- Column 1 Column 2\n- Item Conditions\n- 1 The relevant person must:(a) confirm the absence of aristolochic acids in each batch of the medicine by undertaking chemical analysis of either the raw material or the final medicine, using Liquid Chromatography Mass Spectrometry (LC-MS), where the chemical analysis (the confirmatory evidence):(i) adheres to best practice according to contemporary scientific literature; and(ii) is traceable to the batch of the medicine; and(iii) includes all relevant details of the methodology used, such as analytical method validation data; and(iv) includes the raw results, such as data for a reference standard, the sample and a sample spiked with aristolochic acid at the reporting level; and(b) provide the confirmatory evidence, or a copy of the confirmatory evidence, to the TGA; and(c) not supply a batch of the medicine in Australia until the confirmatory evidence for that batch is approved in writing by the TGA.\n\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains focused on its original purpose of setting conditions for listed medicines. It updates and consolidates previous conditions without expanding into unrelated areas. The three parts address distinct but related aspects of medicine safety (general compliance, sunscreen testing integrity, and aristolochic acid contamination) that all fall within the core regulatory function of ensuring listed medicine safety."},"complexity_factors":["Short instrument with only 5 substantive sections plus a schedule","Only 6 defined terms in section 4, with most definitions referencing the parent Act","Simple tabular format for conditions in Schedule 1 with clear itemisation","Limited cross-referencing—primarily to the Therapeutic Goods Act 1989 and Regulations 1990","No nested exceptions or complex conditional logic; conditions are straightforward obligations","Specific technical requirements in Part 3 (LC-MS testing methodology) require scientific expertise to implement but are clearly expressed in the text"],"plain_english_summary":"This law tightens rules for companies selling low‑risk \"listed\" medicines in Australia—vitamins, many herbal products and sunscreens—by requiring stronger record‑keeping, traceability and recall preparedness. It also forces extra validation for sunscreens relying on certain US lab data and mandates batch‑by‑batch LC‑MS testing plus TGA approval for medicines containing herbs that may carry aristolochic acid.\n\nIt affects manufacturers/importers, the TGA and consumers by improving safety and traceability of these products."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument does not change which goods are eligible to be listed; it sets conditions attached to listings under subsection 28(1) of the Act (see section 5). It identifies three groups subject to conditions—specified listed medicines generally, sunscreens (Schedule 1 Part 2), and medicines that may contain certain aristolochic acid–bearing ingredients (Schedule 1 Part 3)—and prescribes procedural, testing and recordkeeping obligations for the relevant person (definitions in section 4)."},"complexity_factors":["Batch-level testing and pre-supply approval requirement for medicines that may contain aristolochic acids (Schedule 1 Part 3, item 1(a)–(c)) creates operational and timing complexity.","Technical specification of confirmatory evidence: LC‑MS methodology, validation data, raw results and traceability to batch (Schedule 1 Part 3, item 1(a)(i)–(iv)).","Record‑keeping obligations including recall, manufacturer identification and five‑year distribution record retention, with production on TGA request (Schedule 1 Part 1, items 1 and 3).","GMP subcontracting requirement to retain copies of relevant agreements when manufacture is subcontracted in Australia (Schedule 1 Part 1, item 2).","Notification duty to inform TGA of overseas recalls or regulatory actions relevant to quality, safety or efficacy (Schedule 1 Part 1, item 4), which creates ongoing monitoring obligations.","Sunscreen substantiation pathway where AMA Laboratories testing is used requires supplementary in‑vitro or independent lab data or other TGA‑acceptable justification, plus a 10 working‑day turnaround for TGA requests (Schedule 1 Part 2, item 1(a)–(b)); introduces evidentiary choices and potential for bespoke TGA agreement.","TGA discretion points: acceptance of alternative justifications for sunscreen data (Part 2, item 1(a)(iii)) and written approval of batch confirmatory evidence before supply (Part 3, item 1(c)) create uncertainty for timing and outcome.","Compliance cost concentration on the relevant person (registrant): testing, data collection, record retention, and potential delays to supply (definition of relevant person in section 4 and obligations in Schedule 1)."],"plain_english_summary":"This instrument attaches conditions to the listing of certain ‘specified listed medicines’ on the Australian Register. It affects the relevant person (the registrant) by requiring manufacturing and distribution records, five‑year retention, GMP subcontracting agreements and prompt notification to the TGA of overseas recalls.\n\nIt also requires supplementary evidence where AMA Laboratories testing is used for sunscreens and mandates LC‑MS batch testing—and written TGA approval—before supplying medicines that may contain aristolochic acids. The registrant bears testing and documentation costs; the TGA decides acceptability of evidence."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022","history":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022/history","analysis":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022/analysis","conflicts":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022/important-cases","documents":"/api/acts/therapeutic-goods-listed-medicines-conditions-of-listing-determination-2022/documents"}}