{"id":"F2019L01493","name":"Therapeutic Goods (Listed Medicines—Compliance Reviews) Specification 2019","slug":"therapeutic-goods-listed-medicines-compliance-reviews-specification-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440302,"registerId":"F2019L01493-fast-fetch-1775955987243","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Listed Medicines—Compliance Reviews) Specification 2019","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 (Listed Medicines  Compliance Reviews) Specification 2019\n\nI, John Skerritt, as delegate of the Minister for Health, make the following specification.\n\nDated 22 November 2019\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  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 Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Listed MedicinesCompliance Reviews) Specification 2019.\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day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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(5D) of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n(a) label;\n\n(b) listing number;\n\n(c) manufacture;\n\n(d) medicine;\n\n(e) Register; and\n\n(f) Secretary.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\ncompliance review, in relation to a listed medicine, means a post-market review carried out by the Therapeutic Goods Administration for the purpose of determining whether certain requirements of the Act, applicable to the medicine, have been, or are being, complied with.\n\nNote:  For example, a compliance review may include verifying the certification made by a relevant sponsor under section 26A or 26AB of the Act in relation to the relevant medicine.\n\nlisted medicine means a medicine that is included in the Part of the Register for goods known as listed goods.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant medicine means the listed medicine that is the subject of a compliance review.\n\nrelevant sponsor means the person in whose name the relevant medicine is listed in the Register.\n\nTherapeutic Goods Administration has the same meaning as in the Regulations.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Therapeutic goods information\n\nThe kinds of therapeutic goods information set out in column 2 of the table in Schedule 1, as described in column 3 of the corresponding item, 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\n\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1 Column 2 Column 3\n- Item Information Description\n- 1 name of medicine the name of the relevant medicine\n- 2 listing number the listing number of the relevant medicine, commonly known as the ARTG ID\n- 3 review outcome a summary of the outcome of the compliance review in relation to the relevant medicine, including:(a) whether the relevant medicine remains listed on the Register and may continue to be supplied; and(b) the circumstances in which the relevant medicine may continue to be supplied, including in relation to changes that have been made by the relevant sponsor to address issues identified during the compliance review in relation to the medicine\n- 4 consumer advice in relation to continued use a recommendation as to whether the relevant medicine is considered safe for continued use by consumers, including:(a) the reasons for the recommendation;(b) the circumstances in which the use of the relevant medicine is considered safe\n- 5 consumer advice in relation to required action a recommendation as to the action a consumer of the relevant medicine should take, for example:(a) no action;(b) reconsidering whether the relevant medicine is right for the consumer;(c) seeking medical advice;(d) disposing of the relevant medicine;(e) contacting the Therapeutic Goods Administration\n- 6 sponsor the name of the relevant sponsor\n- 7 review type the type of compliance review carried out in relation to the relevant medicine, as follows:(a) random; or(b) targeted\n- 8 information reviewed the type of information reviewed during the compliance review of the relevant medicine, for example:(a) the label of the relevant medicine;(b) evidence held by the relevant sponsor in relation to the indications of, and claims made for, the relevant medicine;(c) documents relating to the manufacture of the relevant medicine;(d) promotional and advertising material in relation to the relevant medicine;(e) information included in the entry in the Register that relates to the relevant medicine\n- 9 issues relating to safety a summary of any issues identified during the compliance review that relate to the safety of the relevant medicine, including contraventions of the Act\n- 10 issues relating to efficacy a summary of any issues identified during the compliance review that relate to the efficacy of the relevant medicine, including contraventions of the Act\n- 11 actions taken during the review a summary of any relevant actions taken by the relevant sponsor or the Therapeutic Goods Administration during the compliance review of the relevant medicine, for example:(a) an update to the listing of the relevant medicine on the Register by the relevant sponsor;(b) an update to the label of the relevant medicine by the relevant sponsor;(c) a request by the relevant sponsor for the cancellation of the listing of the relevant medicine from the Register following notification of issues;(d) a request by the relevant sponsor for the cancellation of the listing of the relevant medicine from the Register following a request for information under section 31 of the Act;(e) the cancellation of the listing of the relevant medicine from the Register by the Secretary, where the cancellation was not at the request of the relevant sponsor\n- 12 grounds for cancellation where applicable, the grounds for the cancellation of the listing of the relevant medicine from the Register\n- 13 date of cancellation where applicable, the date that the listing of the relevant medicine was cancelled from the Register by the Secretary, where the cancellation was not at the request of the relevant sponsor\n- 14 date of review outcome the date that the outcome of the compliance review was notified to the relevant sponsor by the Therapeutic Goods Administration, being the date that the compliance review was concluded\n- 15 date of publication the date that the information in relation to the compliance review of the relevant medicine was published on the Therapeutic Goods Administration’s website\n- 16 additional information details of any relevant information, actions taken, or decisions made, in relation to the relevant medicine after the conclusion of the compliance review\n\n\n\n\n\nSchedule 2Repeals\n\nNote: See section 6.\n\nTherapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n\n \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":2,"scope_assessment":{"changed":true,"description":"The legislation expands scope compared to its predecessor. The repealed 2012 instrument covered only 'listed complementary medicines' (a subset), while this 2019 specification covers all 'listed medicines' — a broader category that includes not just complementary medicines (vitamins, herbal remedies) but also certain over-the-counter medicines. This reflects a policy shift toward greater transparency across the entire listed medicines sector rather than just the complementary segment."},"complexity_factors":["Short instrument: only 6 sections plus 2 schedules","Minimal defined terms: only 6 definitions in section 4, plus references to existing definitions in the parent Act","Simple structure: straightforward table format in Schedule 1 listing 16 data fields with plain English descriptions","No nested exceptions or conditional logic: the specification operates as a simple 'positive list' of publishable information","Single cross-reference: only refers to the enabling provision (Therapeutic Goods Act 1989, subsection 61(5D)) and standard definitions","Repeal mechanism is straightforward: repeals one previous instrument in its entirety"],"plain_english_summary":"This law lets the Therapeutic Goods Administration publish outcomes of compliance checks on listed medicines (OTC products that don’t need pre‑approval). It makes results about issues, safety advice and sponsor responses publicly available.\n\nThat change affects consumers (better transparency about products they buy), sponsors (public disclosure of review findings), and the TGA (clear power to publish). It expands and replaces the 2012 rule, covering all listed medicines."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"This instrument replaces the 2012 Specification (see Schedule 2) and applies to 'listed medicine' generally rather than—by title—only to 'listed complementary medicines'. It therefore broadens the explicit coverage of publishable compliance‑review outcomes, enumerating 16 categories of information the Secretary may release (see section 5 and Schedule 1), which increases the range of possible public disclosures about sponsors and their listings."},"complexity_factors":["Delegated authority and statutory cross‑references: made under subsection 61(5D) of the Therapeutic Goods Act 1989 (see section 3 of the instrument) yet operates by reference to subsection 61(5C) for publication — requires reading both the instrument and the Act to see legal effect.","Reliance on Act definitions: many terms (listed medicine, Register, Secretary, label, listing number) are defined in section 3 of the Act and the Regulations (see section 4 of the instrument), creating dependency on external texts.","Discretion in content and presentation: Schedule 1 uses open‑ended language such as “a summary”, “a recommendation” and “additional information” (items 3–5, 16), which leaves substantive judgment to the Secretary/TGA about scope and detail of published material.","Operational and compliance implications for sponsors: items in Schedule 1 (e.g. actions taken, grounds/date of cancellation — items 11–13) can impose administrative tasks and potential reputational/commercial impacts on relevant sponsors.","Interaction with other Act powers and processes: the definition of compliance review references checks under sections 26A/26AB and requests under section 31 of the Act (see definition and Schedule 1 examples), so publication may follow varied procedural triggers.","Transitional and repeal mechanics: the instrument repeals the 2012 specification in full (see Schedule 2), requiring comparison of prior and current scopes to determine changed obligations and expectations.","Timing and commencement clarity: section 2 provides a single commencement rule (day after registration) but warns published versions may include non‑instrument notes, requiring attention to authoritative commencement details."],"plain_english_summary":"This specification names the kinds of information the Secretary may publish after a Therapeutic Goods Administration (TGA) compliance review of a listed medicine, and it repeals the 2012 instrument. It affects sponsors of listed medicines (who may face public disclosure, reputational and compliance costs) and consumers (who receive safety and action advice). The TGA decides what to publish, which creates incentives for sponsors to update listings and to cooperate with reviews."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019","history":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019/history","analysis":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019/analysis","conflicts":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019/important-cases","documents":"/api/acts/therapeutic-goods-listed-medicines-compliance-reviews-specification-2019/documents"}}