{"id":"F2020L01649","name":"Therapeutic Goods (Prescription Medicines—Transparency Measures) Specification 2020","slug":"therapeutic-goods-prescription-medicines-transparency-measures-specification-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440710,"registerId":"F2020L01649-fast-fetch-1775956250912","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Prescription Medicines—Transparency Measures) Specification 2020","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 (Prescription Medicines—Transparency Measures) Specification 2020\n\nI, John Skerritt, as delegate of the Minister for Health, make the following specification.\n\nDated 17 December 2020\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—Specified kinds of therapeutic goods information\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Prescription Medicines—Transparency Measures) Specification 2020.\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instrument 1 January 2021. 1 January 2021\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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) indications;\n\n(b) medicine;\n\n(c) passed preliminary assessment;\n\n(d) registered goods;\n\n(e) Secretary; and\n\n(f) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nnew indications medicine has the same meaning as in the Regulations.\n\nnew prescription medicine has the same meaning as in the Regulations.\n\nregistered medicine means a medicine that is a registered good.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant medicine means a new prescription medicine or a new indications medicine, which is the subject of an application for registration under section 23 of the Act that has passed preliminary assessment, but does not include a medicine that is a biosimilar in relation to a registered medicine.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Release of therapeutic goods information\n\n  The 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\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 the name of the relevant medicine\n- 2 applicant the name of the person who made the application for the registration of the relevant medicine\n- 3 active ingredients the active ingredients contained in the relevant medicine\n- 4 indications a summary of the proposed indications of the relevant medicine\n- 5 application type the type of application that was made in relation to the relevant medicine, as follows:(a) new chemical entity (type A);(b) new combination (type B); or(c) extension of indications (type C)\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"},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument exercises the power in subsection 61(5D) of the Therapeutic Goods Act 1989 to specify kinds of therapeutic goods information for public release under subsection 61(5C). It does not itself expand statutory definitions or change registration requirements; it identifies which items (eg. name, applicant, active ingredients, indications, application type) may be released and explicitly excludes biosimilars from the 'relevant medicine' category (s3–s5, Schedule 1)."},"complexity_factors":["Short, focused instrument but relies heavily on cross‑references to the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 (see s3, s4)","Multiple statutory definitions required to identify scope (eg. 'relevant medicine', 'therapeutic goods information') rather than self‑contained definitions (s4)","Exclusion of biosimilars from 'relevant medicine' adds a boundary that must be checked against existing registrations (s4)","Specification is table‑based (Schedule 1) rather than prose, requiring interpretation of listed items against the Act's concept of 'therapeutic goods information' (s5, Schedule 1)","Operational discretion remains with the Secretary under subsection 61(5C) of the Act; the instrument specifies what may be released but not procedures, timing or format (s5, note)","Commencement and application timing are explicit (commences 1 Jan 2021) but the instrument does not alter substantive registration procedure—interpretation requires reading with the Act and Regulations (Commencement, s2)"],"plain_english_summary":"This specification requires the Secretary to publish certain information about “relevant medicines” — new prescription medicines or medicines with new indications that have passed preliminary assessment. It affects applicants seeking registration (their identity and basic product details) and anyone who uses registration data, because it makes that information publicly available under the Therapeutic Goods Act."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose of specifying what therapeutic goods information must be released for transparency purposes. It has not expanded beyond the narrow scope of publishing basic details about prescription medicines under assessment."},"complexity_factors":["Very short instrument (approximately 2 pages of substantive content)","Only 6 defined terms in section 4, with most definitions simply cross-referencing the parent Act or Regulations","Single operative provision (section 5) with straightforward tabular specification","No nested exceptions or conditional logic — the only exclusion (biosimilars) is clearly stated in the definition of 'relevant medicine'","Minimal cross-referencing: only references to the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 for standard definitions","Simple tabular structure in Schedule 1 listing only 5 discrete categories of information to be released"],"plain_english_summary":"This law requires the Department of Health to publicly disclose key details about prescription medicines that are under registration—covering new drugs and existing drugs seeking new indications—so the public can see what treatments are in the pipeline. Biosimilars are excluded.\n\nBy revealing basic information (name, applicant, active ingredients, intended indications and application type), it increases transparency for clinicians, patients, researchers and planners ahead of formal approval."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020","history":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020/history","analysis":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020/analysis","conflicts":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020/important-cases","documents":"/api/acts/therapeutic-goods-prescription-medicines-transparency-measures-specification-2020/documents"}}