{"id":"F2025L00267","name":"Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025","slug":"therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":442768,"registerId":"F2025L00267-fast-fetch-1775957708575","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025","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 (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025\n\nI, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following instrument.\n\nDated 28 February 2025\n\nTracey Duffy\n\nFirst Assistant Secretary  Medical Devices and Product Quality Division  Health Products Regulation Group  Department 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  Therapeutic goods information\n\n6  Repeals\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nSchedule 2—Repeals\n\nTherapeutic Goods (System for Australian Recall Actions) (Information) Specification 2023\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025.\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. Sections 1 to 6 and anything in this instrument not elsewhere covered by this table The day after this instrument is registered.\n- 2. Schedule 1 The day after this instrument is registered.\n- 3. Schedule 2 5 April 2025. 5 April 2025\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 61(5D) 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) biological number;\n\n(b) device number;\n\n(c) health practitioner;\n\n(d) included in the Register;\n\n(e) indications;\n\n(f) listed goods;\n\n(g) listing number;\n\n(h) Register;\n\n(i) registered goods;\n\n(j) registration number;\n\n(k) Secretary;\n\n(l) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\naction commencement date means the date the market action to be implemented by the responsible entity was agreed to by the TGA.\n\naction level means the level of market action to be implemented by the responsible entity, based on the persons or bodies, or classes of persons or bodies, that are affected, or likely to be affected, by the market action.\n\nNote: The TGA determines the action level as one of the following:\n\n(a) Wholesale level;\n\n(b) Hospital level;\n\n(c) Retail level;\n\n(d) Consumer level.\n\nactive ingredient has the same meaning as in the TG Regulations.\n\nhazard classification means the classification of the market action determined by the TGA, based on the seriousness of the harm that may be caused by the therapeutic goods to which the market action relates, and the likelihood of that harm occurring.\n\nNote: The TGA classifies market actions as one of the following:\n\n(a) Class I – Critical safety-related;\n\n(b) Class II – Urgent safety-related;\n\n(c) Class III – Lowest risk.\n\ninstructions for users means instructions or advice to be given by the responsible entity to health practitioners and other persons affected, or likely to be affected, as part of the market action.\n\nmarket action, in relation to therapeutic goods supplied in Australia, means one or more of the following measures taken, being taken or to be taken by the responsible entity to address a problem or concern relating to the quality, safety, efficacy or performance, presentation or use of the goods:\n\n (a) recall or destruction of all or some of the goods;\n\n (b) notification to the public or particular persons, or classes of persons, of the problem or concern, and provision of advice for risk or harm mitigation;\n\n (c) rectification of a problem with the goods, including by (but not limited to) repairing, modifying, adjusting or relabelling the goods.\n\nMD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nresponsible entity, in relation to therapeutic goods, means:\n\n (a) if the goods are registered goods, listed goods or included in the Register—the person in relation to whom the goods are registered, listed or included in the Register; or\n\n (b) if the goods are not registered goods, listed goods or included in the Register—the supplier of the goods in Australia.\n\nTGA means the part of the Department known as the Therapeutic Goods Administration.\n\nTGA action ID means the unique combination of numbers, symbols and letters that the TGA assigns to a market action.\n\nTG Regulations means the Therapeutic Goods Regulations 1990.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\ntrade name has the same meaning as in the TG Regulations.\n\nunique product identifier has the same meaning as in the MD Regulations.\n\n5  Therapeutic goods information\n\n  The kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purpose of subsection 61(5C) of the Act.\n\nNote: 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\n6  Repeals\n\n  Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.  \n\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\n- Therapeutic goods information that may be released to the public\n- Column 1 Column 2\n- Item Kinds of therapeutic goods information\n- 1 information about market actions in relation to therapeutic goods, that is held by the TGA in its Database of Recalls, Product Alerts and Product Corrections, including:(a) details of the goods, including trade names, indications, active ingredients (where relevant) and other information about the goods;(b) the type of goods, such as medicine, biological or medical device;(c) the registration number, listing number, biological number or device number of the goods;(d) any unique identifier that would enable identification of a medical device (including identification of the model or other information relating to the device);(e) the unique product identifier of the goods;(f) details of the market action taken, being taken or to be taken;(g) details of the problem or concern relating to the goods;(h) the action commencement date;(i) the hazard classification;(j) the action level;(k) the TGA action ID;(l) the responsible entity;(m) the instructions for users;(n) contact information of the responsible entity\n\n\n \n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods (System for Australian Recall Actions) (Information) Specification 2023\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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument appears to maintain the same scope as its predecessor (the 2023 System for Australian Recall Actions). It specifies what therapeutic goods information may be released to the public regarding recalls and safety alerts. While it expands the title to explicitly mention 'Database of Recalls, Product Alerts and Product Corrections,' this appears to be clarifying and formalising the public transparency function rather than expanding beyond the original intent of making recall information publicly accessible."},"complexity_factors":["Short instrument (6 sections plus 2 schedules, approximately 3 pages)","Only 12 defined terms in section 4, most referencing existing definitions in parent legislation","Simple structure: definitions, specification of information types, repeal of predecessor","No nested conditional logic or exceptions","Single cross-reference to parent Act (Therapeutic Goods Act 1989) for authority","Schedule 1 presents information requirements in a straightforward table format","Repeal provision is simple and unambiguous"],"plain_english_summary":"This law requires the Therapeutic Goods Administration to operate a public Database of Recalls, Product Alerts and Product Corrections that publishes detailed information whenever a medicine, medical device or other therapeutic product is recalled, alerted or corrected. It gives consumers, clinicians, pharmacies, hospitals and product sponsors clear, searchable transparency about safety problems, who must act, and what’s being done—making it easier to find and respond to product safety issues."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument replaces the 2023 information specification (s6; Schedule 2) and expressly lists the kinds of database fields the TGA may release (s5; Schedule 1). It therefore narrows uncertainty by naming specific data elements—product identifiers, model/device identifiers, registration/listing numbers, action metadata, instructions for users and contact details (Schedule 1(a)–(n)). Who pays: responsible entities bear the compliance and disclosure exposure (s4 'responsible entity'; Schedule 1(l), (n)). Who decides: the TGA/Secretary determine hazard classification, action level and may release the information (s4 definitions; s5). Behaviour/compliance effects: entities should expect public disclosure of detailed identifiers and market‑action content, creating record‑keeping and reputational consequences; administrative discretion remains with the TGA/Secretary over timing and release (s5 note)."},"complexity_factors":["Delegated instrument with multiple cross‑references to the Act and regulations (see s3; s4 definitions referencing Act, TG Regulations, MD Regulations).","Technical data fields specified for public release, including device identifiers and unique product identifier (Schedule 1 items d, e).","Embedded operational classifications determined by the TGA (hazard classification and action level defined in s4).","Discretion over public release tied to subsection 61(5C) of the Act (see s5 note), creating an administrative decision node.","Staged commencement dates and an explicit repeal of the 2023 instrument (s2; s6; Schedule 2).","Broad definition of 'market action' covering recalls, notifications and rectifications (s4 'market action'), increasing scope of releasable events.","Reliance on defined actor roles that shift compliance exposure to responsible entities (s4 'responsible entity')."],"plain_english_summary":"This instrument tells the Therapeutic Goods Administration (TGA) which fields from its Database of Recalls, Product Alerts and Product Corrections may be released to the public under subsection 61(5C) of the Therapeutic Goods Act 1989, and it repeals the 2023 information specification. It affects responsible entities (manufacturers or suppliers), health practitioners and the public by making product identifiers, market‑action details, hazard classifications, action levels and contact information publicly releasable, changing what information is available and who must anticipate public disclosure."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio","history":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio/history","analysis":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio/analysis","conflicts":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio/conflicts","importantCases":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio/important-cases","documents":"/api/acts/therapeutic-goods-information-specification-database-of-recalls-product-alerts-and-product-correctio/documents"}}