{"id":"F2021L01324","name":"Therapeutic Goods (Restricted Medicines) Specification 2021","slug":"therapeutic-goods-restricted-medicines-specification-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441004,"registerId":"F2021L01324-fast-fetch-1775956441332","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Restricted Medicines) Specification 2021","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 (Restricted Medicines) Specification 2021\n\nI, Jane Cook, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 23 September 2021\n\nDr Jane Cook\n\nFirst Assistant Secretary  Medicines Regulation Division  Health Products Regulation Group  Department of Health\n\n \n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Restricted medicines\n\n6  Repeals\n\nSchedule 1—Restricted medicines\n\nSchedule 2—Repeals\n\nRestricted Medicine Specification 2011\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Restricted Medicines) Specification 2021.\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 30 September 2021. 30 September 2021\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsections 3(2A) and 3(2B) 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) current Poisons Standard;\n\n(b) medicine;\n\n(c) restricted medicine.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\n5  Restricted medicines\n\n (1) For subsection 3(2A) of the Act, a medicine mentioned in an item in the table in Schedule 1 is specified for the purposes of paragraph (a) of the definition of restricted medicine in subsection 3(1) of the Act.\n\n (2) For subsection 3(2B) of the Act, a medicine included in a class of medicine mentioned in an item in the table in Schedule 1 is specified for the purposes of paragraph (b) of the definition of restricted medicine in subsection 3(1) of the Act.\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\n\n\nSchedule 1—Restricted medicines\n\nNote: See section 5.\n\n \n\n- Restricted medicines\n- Column 1 Column 2\n- Item Medicine or class of medicine\n- 1 a medicine that is a product of a kind mentioned in an item in the table in Part 1 of Schedule 10 to the Regulations, other than a product mentioned in:(a) paragraph (b) in column 2 of item 1; or(b) item 14\n- 2 a medicine that contains a substance in Schedule 3 to the current Poisons Standard\n\n\n \n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nRestricted Medicine Specification 2011\n\n1  The whole of the instrument\n\nRepeal the instrument.\n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This is a straightforward re-enactment and update of the 2011 specification. The scope remains identical: specifying which medicines fall under the statutory definition of 'restricted medicine' in the Therapeutic Goods Act 1989. The instrument performs the same function as its predecessor, merely updating the legislative reference framework."},"complexity_factors":["Very short instrument (approximately 2 pages of substantive content)","Only 4 defined terms in section 4, with most definitions referencing external legislation","Heavy reliance on external cross-references (Schedule 10 to the Regulations, Schedule 3 to the Poisons Standard) rather than listing medicines directly","Simple structure: name, commencement, authority, definitions, operative provisions, schedules","Only 2 items in the operative table (Schedule 1), though item 1 contains nested exceptions","No conditional logic or \"if/then\" provisions beyond the basic exclusion clauses in item 1"],"plain_english_summary":"This instrument replaces the 2011 specification with a 2021 version that updates which medicines are legally \"restricted medicines\" under the Therapeutic Goods Act 1989. It covers specific listed products (with some exclusions) and any medicine containing a substance in Schedule 3 of the Poisons Standard.  \n\nIt affects manufacturers, importers, pharmacists and other health providers, and patients by clarifying which pharmacist-only and other restricted products are subject to tighter regulatory controls."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"The instrument repeals the Therapeutic Goods (Restricted Medicine) Specification 2011 and re‑specifies which medicines are ‘restricted’ by reference to (a) product types in Part 1 of Schedule 10 to the Regulations (with stated exceptions) and (b) substances in Schedule 3 of the current Poisons Standard (Schedule 1; s5, s6). The text therefore replaces the prior specification; the instrument itself does not state how the defined set differs in substance from the 2011 instrument, so assessing the precise substantive change requires a side‑by‑side comparison with the repealed instrument."},"complexity_factors":["Extensive cross‑references to external instruments: the Regulations (Part 1 of Schedule 10) and the current Poisons Standard (Schedule 3) increase interpretive work (s5; Schedule 1).","Dependence on definitions in the parent Act (subsection 3(1)) rather than restating terms, requiring users to consult the Act for key meanings (s4 note).","Use of cryptic internal exceptions: item 1 in Schedule 1 excludes products mentioned in paragraph (b) in column 2 of item 1 and item 14 of Schedule 10, creating layered exclusion logic (Schedule 1, item 1).","Delegated decision‑making: instrument made by Minister’s delegate under ss 3(2A)–(2B), concentrating rule‑setting authority in delegated executive action (s3).","Repeal and replacement of the prior specification requires comparison to prior instrument to confirm net scope changes (s6; Schedule 2).","Formal commencement mechanics and notes limit interpretive clarity about retrospective or staged effect (s2)."],"plain_english_summary":"This specification sets out which medicines count as “restricted medicines” under the Therapeutic Goods Act by naming two categories: products of the kind listed in Part 1 of Schedule 10 to the Regulations (with stated exceptions) and medicines containing substances in Schedule 3 of the current Poisons Standard (Schedule 1; s5). It applies to manufacturers, suppliers, pharmacists and retailers by making those products subject to the Act’s supply controls; it was made by the Minister’s delegate (s3) and repeals the 2011 specification (s6)."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021","history":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021/history","analysis":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021/analysis","conflicts":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021/important-cases","documents":"/api/acts/therapeutic-goods-restricted-medicines-specification-2021/documents"}}