{"id":"F2022L01650","name":"Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (2022 Measures No. 1) Instrument 2022","slug":"therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441657,"registerId":"F2022L01650-fast-fetch-1775956915521","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (2022 Measures No. 1) Instrument 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 (Therapeutic Goods Advertising Code) Amendment (2022 Measures No. 1) Instrument 2022\n\nI, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following instrument.\n\nDated 14 December 2022\n\nAdjunct Professor John Skerritt\n\nDeputy Secretary\n\nHealth Products Regulation Group\n\nDepartment of Health and Aged Care\n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Schedules\n\nSchedule 1—Amendments\n\nTherapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021\n\nSchedule 2—Repeals\n\nTherapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 5) 2021\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Therapeutic Goods Advertising Code) Amendment (2022 Measures No. 1) Instrument 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 20 December 2022. 20 December 2022\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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 42BAA of the Therapeutic Goods Act 1989.\n\n4  Schedules\n\n  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.\n\nSchedule 1—Amendments\n\nTherapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021\n\n1  Paragraph 6(1)(c) (including the note) of Schedule 1\n\nRepeal the paragraph, substitute:\n\n (c) made in accordance with the Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022 made under section 42DK of the Act, as in force or existing on 20 December 2022.\n\nNote: The Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022 is published on the Department’s website at www.tga.gov.au.\n\n2  Application of amendments\n\nThe amendments made by this instrument apply in relation to an advertisement occurring after the commencement of this instrument.\n\n\n\n\nSchedule 2—Repeals\n\nTherapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 5) 2021\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"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":3,"scope_assessment":{"changed":true,"description":"The instrument changes the scope of paragraph 6(1)(c) of the Therapeutic Goods Advertising Code by replacing its text so that advertisements 'made in accordance with' the Therapeutic Goods (Restricted Representations—COVID‑19 Vaccines) Permission 2022 are treated under that Permission (Schedule 1, item 1). It also repeals the earlier Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 5) 2021 (Schedule 2, item 1). Practically, this updates which COVID‑19 vaccine representations are captured or permitted by linking the Advertising Code to the 2022 Permission; the instrument itself does not restate the Permission’s substantive rules, so the Permission’s terms determine the operative scope."},"complexity_factors":["Targeted, single-text change: substitutes one paragraph in Schedule 1 of the 2021 Advertising Code (Schedule 1, item 1).","Cross-reference to an external, substantive instrument (Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022) whose terms determine the real regulatory effects (Schedule 1, new paragraph 6(1)(c)).","Commencement and temporal application require advertisers to check the date of advertisement occurrence (Commencement, section 2; Application of amendments, Schedule 1 item 2).","Repeal of a prior amendment instrument removes earlier authority or wording, so legal history must be checked to know what changed (Schedule 2, item 1).","Delegated administrative authority: instrument made by a ministerial delegate under s42BAA of the Therapeutic Goods Act 1989, relying on a Permission made under s42DK (Authority, section 3).","Compliance burden concentrated on advertisers, who must verify conformity with the separate Permission; substantive obligations are not reproduced here but referenced externally (note in replacement paragraph directing to the Department website)."],"plain_english_summary":"This instrument amends the Therapeutic Goods Advertising Code to treat COVID‑19 vaccine advertising that is “made in accordance with” the Therapeutic Goods (Restricted Representations—COVID‑19 Vaccines) Permission 2022 as governed by that Permission. It takes effect 20 December 2022 and applies to advertisements occurring after that date. Advertisers must ensure vaccine ads comply with the Permission; the Department (TGA) enforces compliance. The instrument also repeals an earlier 2021 amendment instrument."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This is a minor technical amendment maintaining the existing regulatory framework. It simply updates a cross-reference to point to a newer permission instrument and removes an obsolete amendment. The scope remains limited to therapeutic goods advertising, specifically COVID-19 vaccine advertising permissions."},"complexity_factors":["Very short instrument (only 2 substantive provisions)","Single amendment replacing one cross-reference","One repeal of an entire instrument","No defined terms section","Simple application provision with clear temporal trigger","No nested conditions or exceptions"],"plain_english_summary":"This instrument updates Australia’s therapeutic goods advertising rules to refer to the current \"Therapeutic Goods (Restricted Representations—COVID-19 Vaccines) Permission 2022\" and repeals a now‑redundant 2021 amendment, keeping COVID‑19 vaccine advertising governed by the correct permission for restricted representations.\n\nIt affects anyone advertising COVID‑19 vaccines — pharmaceutical companies, healthcare providers and the TGA — and applies to advertisements published after 20 December 2022."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022","history":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022/history","analysis":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022/analysis","conflicts":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022/important-cases","documents":"/api/acts/therapeutic-goods-therapeutic-goods-advertising-code-amendment-2022-measures-no-1-instrument-2022/documents"}}