{"id":"F2016L00703","name":"Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016","slug":"therapeutic-goods-information-exemptions-from-annual-charges-specification-2016","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":129263,"registerId":"commonwealth-F2016L00703-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016","content":"Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016\n\nTherapeutic Goods Act 1989\n\nI, Larry Kelly, a delegate of the Minister for Health, make this Specification under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\nDated 4 May 2016\n\n(Signed by)\n\nLARRY KELLY\n\nDelegate of the Minister for Health\n\n  \n\n1 Name of Specification\n\nThis Specification is the Therapeutic Goods Information (Exemptions from Annual Charges) Specification 2016.\n\n2 Commencement\n\nThis Specification commences on 1 July 2016.\n\n3 Definitions\n\nIn this Specification:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> Annual Charges Exemption Scheme means the scheme relating to exemptions from liability to pay annual charges set out in Subdivision 2 of Division 1 of Part 7 of the Regulations.\n\n> ARTG means the Australian Register of Therapeutic Goods.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> Sponsor means the person in relation to whom therapeutic goods are registered, listed or included in the ARTG.\n\n4 Therapeutic goods information\n\nThe kinds of therapeutic goods information mentioned in Schedule 1 are specified under subsection 61(5D) of the Act for the purposes of subsection 61(5C) of the Act.\n\nSchedule 1 Specified kinds of therapeutic goods information\n\n(section 4)\n\n    The following kinds of therapeutic goods information:\n\n    Note: The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act.\n\n    Kinds of therapeutic goods information relating to exemptions under the Annual Charges Exemption Scheme\n\n| Item | Information                                                   | Description                                                                                                                                                                                                                                                                                           |\n| ---- | ------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| (a)  | Sponsor name                                                  | The name of the sponsor in relation to whom therapeutic goods were registered, listed or included in the ARTG in a particular financial year and who was exempt from paying an annual charge in relation to those goods in that financial year.                                                       |\n| (b)  | ARTG number                                                   | The ARTG number of the therapeutic goods in relation to which the exemption applied.                                                                                                                                                                                                                  |\n| (c)  | Name of the therapeutic goods                                 | The name of the therapeutic goods as it appeared in the relevant ARTG entry in relation to which the sponsor was exempt from paying an annual charge in the relevant financial year.                                                                                                                  |\n| (d)  | Exemption from annual charges for a particular financial year | That the sponsor was, for a particular financial year, exempt under the Annual Charges Exemption Scheme from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the ARTG, in respect of therapeutic goods as identified by name and ARTG number. |\n\n    Kinds of therapeutic goods information relating to exemptions found not to apply under the Annual Charges Exemption Scheme\n\n| Item | Information                                                      | Description                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n| ---- | ---------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |\n| (a)  | Sponsor name                                                     | The name of the sponsor in relation to whom therapeutic goods were registered, listed or included in the ARTG in relation to a particular financial year, and who:declared, under regulation 43AAC or 43AAD of the Regulations that the turnover of those goods for that financial year was of low value;did not pay the annual charge for that financial year in relation to those goods; andthe Secretary has given a notice under subregulation 43AAG(2) or (4) of the Regulations, stating that the sponsor was not exempt from liability to pay the annual charge in relation to the goods for that financial year. |\n| (b)  | ARTG number                                                      | The ARTG number of the therapeutic goods mentioned in (a).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| (c)  | Name of the therapeutic goods                                    | The name of the therapeutic goods mentioned in (a), as it appeared on the relevant ARTG entry in relation to which the sponsor was not exempt from paying the annual charge in that financial year.                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| (d)  | No exemption from annual charges for a particular financial year | That, notwithstanding that the sponsor had declared under regulation 43AAC or 43AAD of the Regulations that the turnover of the goods mentioned in (a) for that financial year was of low value, the Secretary has given the sponsor a notice under subregulation 43AAG(2) or (4) of the Regulations, stating that the sponsor was not exempt under the Annual Charges Exemption Scheme from liability to pay the annual charge in relation to the goods for that financial year.                                                                                                                                        |\n\n> Note\n\n> Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au","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":2,"scope_assessment":{"changed":false,"description":"This Specification does not change who is eligible for or liable under the Annual Charges Exemption Scheme. Instead it prescribes which pieces of information about exemptions and about notices finding exemptions not to apply may be released publicly under s61(5C)/(5D) of the Act (see s4 and Schedule 1). It clarifies disclosure content but does not amend the Exemption Scheme or the Regulations."},"complexity_factors":["Narrow, tightly defined subject matter: only specifies data fields to be released (Schedule 1).","Cross‑references to external instruments: relies on Therapeutic Goods Act s61(5C)/(5D) and Regulations (defined terms and regs 43AAC, 43AAD, 43AAG) (see s3, s4, Schedule 1).","Administrative discretion over publication: Secretary may release the listed information under s61(5C) (noted in Schedule 1), requiring exercise of official judgment.","Conditional distinctions in disclosure: separates items where an exemption applied from cases where a declared low turnover was later found not to exempt (Schedule 1), introducing dependency on prior regulatory notices (subreg 43AAG(2)/(4)).","Simple, structured data fields (sponsor name, ARTG number, product name, exemption status) reduce operational complexity for implementation."],"plain_english_summary":"Specifies the kinds of therapeutic‑goods information the Secretary may publish about annual‑charge exemptions and related notices. It lists sponsor name, ARTG number, product name and whether an exemption applied (or was later found not to apply). This affects sponsors (whose entries and exemption status may be public) and the Secretary (who decides disclosure) (see s4, Schedule 1). It matters because it defines what exemption data is released under the Act."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: specifying what therapeutic goods information about annual charge exemptions can be made public. It has not expanded beyond this narrow transparency function."},"complexity_factors":["Very short document (4 substantive sections plus Schedule)","Only 5 defined terms in section 3","Simple structure: definitions, operative provision, and a Schedule with two tables","No nested exceptions or complex conditional logic — just two straightforward categories of information (exemptions granted and exemptions denied)","Minimal cross-referencing — only references to specific subsections of the parent Act and Regulations to establish legal authority","Clear tabular format for the actual information specifications"],"plain_english_summary":"This Specification authorises the Health Department to publish which companies and products receive—or are denied—exemptions from annual charges for therapeutic goods on the ARTG. \n\nIt affects sponsors (whose exemption status becomes public), the public (who gain transparency), and the Department (clarifying its authority). The measure promotes accountability in the exemption scheme and helps guard against misuse while keeping legitimate small businesses visible."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016","history":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016/history","analysis":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016/analysis","conflicts":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016/conflicts","importantCases":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016/important-cases","documents":"/api/acts/therapeutic-goods-information-exemptions-from-annual-charges-specification-2016/documents"}}