Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 I, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following instrument. Dated 28 February 2025 Tracey Duffy First Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health and Aged Care Contents 1 Name 2 Commencement 3 Authority 4 Definitions 5 Therapeutic goods information 6 Repeals Schedule 1—Specified kinds of therapeutic goods information Schedule 2—Repeals Therapeutic Goods (System for Australian Recall Actions) (Information) Specification 2023 1 Name This instrument is the Therapeutic Goods (Information Specification—Database of Recalls, Product Alerts and Product Corrections) Instrument 2025. 2 Commencement (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. Commencement information Column 1 Column 2 Column 3 Provisions Commencement Date/Details 1. Sections 1 to 6 and anything in this instrument not elsewhere covered by this table The day after this instrument is registered. 2. Schedule 1 The day after this instrument is registered. 3. Schedule 2 5 April 2025. 5 April 2025 Note: This table relates only to the provisions of this instrument as originally made.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. (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. 3 Authority This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989. 4 Definitions Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following: (a) biological number; (b) device number; (c) health practitioner; (d) included in the Register; (e) indications; (f) listed goods; (g) listing number; (h) Register; (i) registered goods; (j) registration number; (k) Secretary; (l) therapeutic goods. In this instrument: Act means the Therapeutic Goods Act 1989. action commencement date means the date the market action to be implemented by the responsible entity was agreed to by the TGA. action 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. Note: The TGA determines the action level as one of the following: (a) Wholesale level; (b) Hospital level; (c) Retail level; (d) Consumer level. active ingredient has the same meaning as in the TG Regulations. hazard 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. Note: The TGA classifies market actions as one of the following: (a) Class I – Critical safety-related; (b) Class II – Urgent safety-related; (c) Class III – Lowest risk. instructions 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. market 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: (a) recall or destruction of all or some of the goods; (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; (c) rectification of a problem with the goods, including by (but not limited to) repairing, modifying, adjusting or relabelling the goods. MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002. responsible entity, in relation to therapeutic goods, means: (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 (b) if the goods are not registered goods, listed goods or included in the Register—the supplier of the goods in Australia. TGA means the part of the Department known as the Therapeutic Goods Administration. TGA action ID means the unique combination of numbers, symbols and letters that the TGA assigns to a market action. TG Regulations means the Therapeutic Goods Regulations 1990. therapeutic goods information has the meaning given by subsection 61(1) of the Act. trade name has the same meaning as in the TG Regulations. unique product identifier has the same meaning as in the MD Regulations. 5 Therapeutic goods information 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. 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). 6 Repeals Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule. Schedule 1—Specified kinds of therapeutic goods information Note: See section 5. Therapeutic goods information that may be released to the public Column 1 Column 2 Item Kinds of therapeutic goods information 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 Schedule 2—Repeals Note: See section 6. Therapeutic Goods (System for Australian Recall Actions) (Information) Specification 2023 1 The whole of the instrument Repeal the instrument.