{"id":"F2021L01179","name":"Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 4) 2021","slug":"therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440972,"registerId":"F2021L01179-fast-fetch-1775956410917","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 4) 2021","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 Amendment (Therapeutic Goods Advertising Code) Instrument (No. 4) 2021\n\nI, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following instrument.\n\nDated 23 August 2021\n\nAdjunct Professor John Skerritt\n\nDeputy Secretary\n\nHealth Products Regulation Group\n\nDepartment of Health\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 Advertising Code (No.2) 2018\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument (No. 4) 2021.\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day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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 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 Advertising Code (No.2) 2018\n\n1  At the end of paragraph 6(2)(c)\n\nAdd:\n\n; or (d) is made in accordance with the Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021 made under section 42DK of the Act, as in force or existing on 24 August 2021.\n\n2  Subsection 6(2) (note)\n\nOmit “Note”, substitute “Note 1”.\n\n3  At the end of subsection 6(2)\n\nAdd:\n\nNote 2: The Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021 is published at www.tga.gov.au.\n\n4  Application of amendments\n\nThe amendments made by this instrument apply in relation to an advertisement occurring after the commencement of this instrument.\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":3,"scope_assessment":{"changed":true,"description":"The instrument expands the Code’s covered representations by expressly including advertisements made in accordance with the HHD Group Permission (Schedule 1, item 1). The change is narrowly targeted to that Permission, takes effect after commencement (clause 2; Schedule 1, item 4), and relies on regulator-issued permission under s42DK; enforcement and compliance therefore require checking adherence to that external Permission (Schedule 1, item 1)."},"complexity_factors":["Narrow, single-purpose amendment adding one explicit cross-reference to a specific Permission (Schedule 1, item 1).","Dependence on an external instrument (the HHD Permission) created under section 42DK; compliance requires checking that Permission’s terms (Schedule 1, item 1).","Delegated administrative authority used to make the instrument (clause 3: made under s42BAA), concentrating decision-making in the regulator.","Temporal application and limited retroactivity: commencement timing set and effect limited to advertisements after commencement (clause 2; Schedule 1, item 4).","Publication and accessibility reliance: note added to record where the Permission is published, creating an operational reference point for compliance checks (Schedule 1, item 3)."],"plain_english_summary":"This instrument amends the Therapeutic Goods Advertising Code to treat advertisements made under the “Therapeutic Goods (Restricted Representations—HHD Group Pty Limited) (AZ) Permission 2021” as covered by paragraph 6(2) (Schedule 1, item 1). It records where that Permission is published (Schedule 1, item 3), commences the day after registration (clause 2) and applies to advertisements after commencement (Schedule 1, item 4).\n\nEffect: advertisers who comply with that specific Permission can rely on the Code treatment; the delegate acts under section 42BAA of the Act to give effect to the change (clause 3), and advertisers must align their messaging to the Permission to avoid enforcement risk."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument maintains the original scope of the Therapeutic Goods Advertising Code. It adds a specific exception for one company's permission but does not expand the overall regulatory framework beyond its intended purpose of controlling therapeutic goods advertising."},"complexity_factors":["Very short instrument (4 sections plus schedule with 4 items)","Single substantive amendment: adding one paragraph (6(2)(d)) to the existing Therapeutic Goods Advertising Code","Only one defined term referenced (the HHD Group permission)","No nested conditional logic or cross-references beyond the single reference to section 42DK of the parent Act","Straightforward application provision (applies to advertisements after commencement)"],"plain_english_summary":"This law amends Australia’s therapeutic goods advertising rules to add a targeted exception allowing certain otherwise‑restricted claims where they comply with a specific permission granted to HHD Group Pty Limited for AstraZeneca products.  \n\nIt affects HHD, advertisers and health professionals who must follow that permission, and consumers who may see different advertising; the change lets the TGA permit narrowly tailored advertising that meets safety and accuracy conditions."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021","history":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021/history","analysis":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021/analysis","conflicts":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021/important-cases","documents":"/api/acts/therapeutic-goods-amendment-therapeutic-goods-advertising-code-instrument-no-4-2021/documents"}}