{"id":"F2019L00050","name":"Therapeutic Goods (Advertising Complaints and Investigations Information) Specification 2019","slug":"therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":98686,"registerId":"commonwealth-F2019L00050-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 (Advertising Complaints and Investigations Information) Specification 2019.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n advertise;\n device number;\n listing number;\n Register;\n registration number;\n\n (f) Secretary;\n (g) therapeutic goods; and\n (h) Therapeutic Goods Advertising Code.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> case means a case created by the Therapeutic Goods Administration:\n\n> (a) in response to a complaint; or\n\n> (b) following a decision of the Therapeutic Goods Administration to undertake an investigation on its own initiative, where it reasonably suspects that an advertisement or dissemination of generic information contravenes the Act, Regulations or Therapeutic Goods Advertising Code.\n\n> case number means any combination of numbers, symbols and letters assigned by the Therapeutic Goods Administration to a case.\n\n> complaint means a complaint alleging that an advertisement or the dissemination of generic information contravenes the Act, Regulations or Therapeutic Goods Advertising Code, which was:\n\n (a) made by a person to the Therapeutic Goods Administration; or\n (b) made by a person to the Complaints Resolution Panel and led to a recommendation being made by the Complaints Resolution Panel to the Secretary under regulation 42ZCAI of the old Regulations; or\n (c) referred to the Therapeutic Goods Administration by a body or an authority.\n\n> Complaints Resolution Panel has the same meaning as in the old Regulations.\n\n> generic information has the same meaning as in section 42B of the Act.\n\n> old Regulations means the Therapeutic Goods Regulations 1990 as in force immediately before the commencement of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018.\n\n> Note: Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 commenced on 1 July 2018.\n\n> outcome means the outcome of a case, or subsequent related action or proceedings in relation to that case, including:\n\n> (a) a finding that there is no contravention of the Act, Regulations or Therapeutic Goods Advertising Code;\n\n> (b) action taken by a responsible person in relation to the advertisement or dissemination of generic information;\n\n> (c) action taken or a decision made by the Secretary in relation to the advertisement or dissemination of generic information;\n\n> (d) a decision of a Court that a person has committed an offence, or contravened a civil penalty provision, under Part 5-1 of the Act in relation to the advertisement or the dissemination of generic information; and\n\n> (e) a decision of a Court ordering an injunction under Part 5A-4 of the Act in response to an application by the Secretary in relation to the advertisement or the dissemination of generic information.\n\n> reference number means any combination of numbers, symbols and letters assigned by the Therapeutic Goods Administration to a complaint or an investigation of the Therapeutic Goods Administration on its own initiative.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> responsible person means the person who appears to be responsible for:\n\n> (a) advertising, by any means, therapeutic goods or causing the advertising, by any means, of therapeutic goods; or\n\n> (b) disseminating, by any means, generic information about therapeutic goods to the public or a section of the public.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.","sortOrder":2},{"sectionNumber":"6","sectionType":"section","heading":"Therapeutic goods information","content":"#### 6 Therapeutic goods information\n\n The kinds of therapeutic goods information set out in column 2 of the table in Schedule 2, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.\n\n> Note: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).\n\nSchedule 2—Specified kinds of therapeutic goods information\n\nNote: See section 6.\n\n| Kinds of therapeutic goods information | |\n| -------------------------------------- | --- |\n\n| Column 1Item | Column 2Information | Column 3Description |\n| ------------ | ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1 | responsible person | the name of the responsible person in relation to the advertisement or dissemination of generic information that is the subject of the case |\n| 2 | therapeutic goods | the name of the therapeutic goods relating to the advertisement or dissemination of generic information that is the subject of the case (the relevant goods) and any other information necessary to identify the relevant goods |\n| 3 | Register number | the device number, listing number or registration number of the relevant goods |\n| 4 | reference number | the relevant reference number |\n| 5 | case number | the relevant case number |\n| 6 | risk category | the level of risk assigned to the relevant case by the Therapeutic Goods Administration |\n| 7 | case details | the details of the case, including:(a) the alleged breach of the Act, Regulations or Therapeutic Goods Advertising Code;(b) the circumstances in which the relevant goods were advertised or the generic information was disseminated, such as means and location;(c) the complaint, or a summary of the complaint, or reason for the investigation commenced by the Therapeutic Goods Administration on its own initiative, relating to the advertisement or dissemination of generic information; and(d) where the complaint led to a recommendation being made to the Secretary under regulation 42ZCAI of the old Regulations:(i) a summary of, and website link to, the Complaints Resolution Panel’s determination and recommendation; and(ii) any identifying number assigned to the complaint by the Complaints Resolution Panel |\n| 8 | outcomes including actions and decisions | the outcomes of the case, including:(a) the findings that led to the outcomes and a summary of, and reasons for, the outcomes;(b) actions taken and decisions made in relation to the case, including a summary of a decision made by the Secretary under the Act or Regulations, and any notice or statement of reasons given for that decision; and(c) a reference or website link to a decision of a court or tribunal in relation to an advertisement or dissemination of generic information that was the subject of the case |\n| 9 | relevant dates | dates relating to the case, including:(a) the date that the complaint was received by the Therapeutic Goods Administration;(b) the date that the recommendation under regulation 42ZCAI of the old Regulations was made by the Complaints Resolution Panel to the Secretary;(c) the date that the investigation was commenced by the Therapeutic Goods Administration on its own initiative;(d) the date or dates of the alleged breach of the Act, Regulations or Therapeutic Goods Advertising Code;(e) the dates of the outcomes, including the dates that actions were taken and decisions were made in relation to the case; and(f) the date that the case was finalised by the Therapeutic Goods Administration |","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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: specifying what therapeutic goods information about advertising complaints and investigations can be published. It has not expanded beyond this transparency function."},"complexity_factors":["13 defined terms in section 4, though most are straightforward","Multiple cross-references to the Therapeutic Goods Act 1989 and Regulations, including references to 'old Regulations' (pre-2018 regime)","Nested definitions (e.g., 'case' defined by reference to 'complaint' and 'investigation')","Schedule 2 table with 9 items of specified information, some containing sub-lists (a)-(f) with further nested items (i)-(ii)","Historical transitional references to the old Complaints Resolution Panel system that existed before July 2018"],"plain_english_summary":"This law sets out what information the government can publish about complaints and investigations into dodgy medical ads. When someone complains about an advertisement for medicines or medical devices (or when the government investigates on its own), the Therapeutic Goods Administration (TGA) creates a 'case'. This document specifies exactly what details about those cases can be made public—including the name of the company responsible, what product was advertised, what the complaint was about, what risk level the TGA assigned, and what the final outcome was (such as fines, court orders, or findings of no wrongdoing). Essentially, it's a transparency measure so the public can see who's been investigated for misleading medical advertising and what happened."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The instrument does not change the statutory power to release information; it merely specifies which kinds of advertising‑related information may be released under subsection 61(5C) of the Act (see section 6 and Schedule 2). It clarifies inclusion of complaints referred by the Complaints Resolution Panel and TGA‑initiated investigations but does not expand or curtail the Act’s enforcement powers (see section 4 definitions and Schedule 2)."},"complexity_factors":["Legal cross-references: instrument is made under subsection 61(5D) of the Act and specifies material releasable under subsection 61(5C) (see section 3 and section 6).","Numerous defined terms and legacy links: multiple definitions and references to the Act, the Regulations, the old Regulations and the Complaints Resolution Panel create layered interpretation requirements (see section 4).","Breadth of required disclosures: Schedule 2 lists identity of responsible person, product names and register numbers, full case details, outcomes, and dates (Schedule 2 items 1–9), increasing disclosure scope and operational complexity.","Administrative discretion: TGA assigns a \"risk category\" to cases (Schedule 2 item 6), introducing discretionary classification that affects what is published.","Interplay with external processes: includes complaints from the Complaints Resolution Panel and court or tribunal decisions, requiring linkage to external documents, links and identifiers (Schedule 2 items 7 and 8).","Privacy and reputational implications: publishing names, detailed allegations and summaries (Schedule 2 items 1 and 7) raises privacy/compliance risk that must be managed by agencies and affected entities.","Operational and recordkeeping burden: requirement to publish summaries, links, reference and case numbers, and dates (Schedule 2 items 3–5, 8–9) demands data collection, redaction and web‑publication work.","Temporal scope and transition issues: references to the old Regulations and matters commenced before a specified date create potential historical-record complexity (definition of old Regulations and related notes)."],"plain_english_summary":"This specification lists the exact categories of advertising- and investigation-related information the Therapeutic Goods Administration (TGA) may publish about complaints and investigations. It affects manufacturers, advertisers and any person deemed the “responsible person” because their identity, product identifiers, case details, outcomes and dates can be released. It matters because it defines what the Secretary may make public under the Therapeutic Goods Act, shaping transparency, reputational risk and record‑keeping obligations."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019","history":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019/history","analysis":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019/analysis","conflicts":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019/important-cases","documents":"/api/acts/therapeutic-goods-advertising-complaints-and-investigations-information-specification-2019/documents"}}