{"id":"F2022L00694","name":"Therapeutic Goods (Minamata Convention) (Information) Specification 2022","slug":"therapeutic-goods-minamata-convention-information-specification-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441380,"registerId":"F2022L00694-fast-fetch-1775956690050","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Minamata Convention) (Information) Specification 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 (Minamata Convention) (Information) Specification 2022\n\nI, John Skerritt, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 9 May 2022   \n\n \n\nAdjunct Professor John Skerritt\n\nDeputy Secretary\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Release of therapeutic goods information\n\nSchedule 1—Therapeutic goods information\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Minamata Convention) (Information) Specification 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 The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsection 61(5AB) 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) Secretary;\n\n(b) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nAgriculture Department means the Department responsible for agriculture policy, including agricultural and veterinary chemicals.\n\nAustralian Border Force has the same meaning as in the Australian Border Force Act 2015.\n\nAustralian Industrial Chemicals Introduction Scheme means the scheme established under section 140 of the Industrial Chemicals Act 2019.\n\nEnvironment Department means the Department responsible for environment policy, including environment protection.\n\nHome Affairs Department means the Department administered by the Minister administering the Australian Border Force Act 2015.\n\nmercury has the same meaning as in the Regulations.\n\nMinamata Convention has the same meaning as in the Regulations.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Release of therapeutic goods information\n\n  For subsection 61(5AA) of the Act, in relation to each item, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1 may be released to a body specified in column 3, for the purposes specified in column 4 of that table.\n\nNote: Under subsection 61(5AA) of the Act, the Secretary may release to a body that is specified under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.\n\n\n\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Therapeutic goods information that may be released\n- Column 1 Column 2 Column 3 Column 4\n- Item Kinds of information Bodies Purpose\n- 1 information about the importation or exportation of therapeutic goods that are mercury including, but not limited to, information that relates to:(a) importations and exportations of therapeutic goods that are mercury that have been approved under the Regulations;(b) the investigation of importations and exportations of therapeutic goods that are mercury and that may not have been approved under the Regulations;(c) relevant import or export data and analysis;(d) the examination and testing of samples of suspected mercury the following bodies:(a) the Home Affairs Department (incorporating the Australian Border Force);(b) the Environment Department;(c) the Agriculture Department;(d) the part of the Department responsible for administering the Australian Industrial Chemicals Introduction Scheme to support cooperation with the bodies mentioned in column 3 in relation to monitoring and supporting compliance with, and enforcement of, border controls relating to mercury (including therapeutic goods that are mercury), to satisfy Australia’s international obligations under the Minamata Convention, and inform and support policy development in relation to mercury\n\n\n \n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument implements the disclosure power in subsection 61(5AA) by specifying which kinds of therapeutic goods information may be shared, who may receive it, and the purposes for disclosure (see s.5 and Schedule 1 Item 1). It clarifies permitted disclosures (types of data and recipient bodies) but does not itself expand the statutory authority in the Act or add new legal powers beyond those the Act enables."},"complexity_factors":["Cross-references to multiple instruments and definitions (Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, and ‘Minamata Convention’) — see Definitions (s.4).","Delegated specification under subsection 61(5AB) of the Act creates legally binding detail via instrument rather than primary legislation — see Authority (s.3).","Single-schedule structure that uses broad, non-exhaustive categories of information (import/export approvals and data, investigations, analyses, sample testing) increases interpretive discretion — see Schedule 1, Column 2 (Item 1).","Multiple recipient bodies across different portfolios (Home Affairs/ABF, Environment, Agriculture, industrial chemicals administration) require cross-agency coordination and data-sharing arrangements — see Schedule 1, Column 3 (Item 1).","Purposes combine compliance/enforcement, international-obligation reporting, and policy development, which can pull data-use in different directions and raise competing requirements for retention, access and confidentiality — see Schedule 1, Column 4 (Item 1).","Operational complexity from handling sensitive import/export and test-sample data at borders and between departments (implied by the kinds of information listed in Schedule 1).","Commencement and application mechanics are simple (whole instrument commences the day after registration) but the downstream administrative and legal effects depend on implementing inter-agency processes — see Commencement (s.2) and Release provision (s.5)."],"plain_english_summary":"This specification allows the Secretary to share certain information about therapeutic goods that contain mercury with specified Commonwealth agencies (Home Affairs/Australian Border Force, Environment, Agriculture, and the office administering the industrial chemicals introduction scheme). It permits release of import/export approvals and data, investigation details, analyses and test results to support border monitoring/enforcement, meet Australia’s Minamata Convention obligations, and inform policy. It affects regulators, border-control agencies and importers/exporters whose records or samples may be disclosed."},"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":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose. It implements a specific information-sharing mechanism under subsection 61(5AB) of the Therapeutic Goods Act 1989 to support Australia's obligations under the Minamata Convention. The scope has not expanded beyond mercury-related therapeutic goods and the four specified recipient bodies."},"complexity_factors":["Very short instrument (5 sections plus a single-item schedule)","Only 7 defined terms, most referencing external legislation rather than creating new definitions","Single operative provision (section 5) with straightforward cross-reference to Schedule 1","Schedule 1 contains only one table with four columns specifying information types, recipient bodies, and purposes","No nested exceptions, conditional logic, or elaborate procedural requirements","Purpose is narrow and specific: facilitating information sharing for mercury-related therapeutic goods under the Minamata Convention"],"plain_english_summary":"This instrument lets the Secretary of Health share otherwise‑confidential TGA information about mercury‑containing therapeutic goods (imports, exports, permits, investigations, testing, and analysis) with Home Affairs (including the Australian Border Force), the Environment and Agriculture departments, and the department overseeing the Australian Industrial Chemicals Introduction Scheme. It enables cross‑agency monitoring and enforcement to meet Australia’s Minamata Convention obligations and curb illegal mercury trade."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022","history":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022/history","analysis":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022/analysis","conflicts":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022/important-cases","documents":"/api/acts/therapeutic-goods-minamata-convention-information-specification-2022/documents"}}