{"id":"F2020L00106","name":"Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) Specification 2020","slug":"therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440370,"registerId":"F2020L00106-fast-fetch-1775956024632","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) 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 (Medicines and Biologicals—Ingredients and Components Information) Specification 2020\n\nI, Jane Cook, as delegate of the Minister for Health, make the following specification.\n\nDated 7 February 2020\n\nDr Jane Cook\n\nFirst Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Therapeutic goods information\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nPart 1—Medicines\n\nPart 2—Biologicals\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Medicines and Biologicals—Ingredients and Components Information) 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 The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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\n1.       biological;\n2.       included in the Register;\n\n\n(c) medicine;\n\n(d) Register; and\n\n(e) therapeutic goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nactive component, in relation to a biological, means a therapeutically active component in the final formulation of the biological that is responsible for its physiological action.\n\nactive ingredient has the same meaning as in the Regulations.\n\nother component, in relation to a relevant biological, means a component of the biological other than:\n\n(a) an active component;\n\n(b) a proprietary colour;\n\n(c) a proprietary flavour; or\n\n(d) a proprietary fragrance.\n\nother ingredient, in relation to a relevant medicine, means an ingredient in the medicine other than:\n\n(a) an active ingredient;\n\n(b) a proprietary colour;\n\n(c) a proprietary flavour; or\n\n(d) a proprietary fragrance.\n\nproprietary colour means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing colour to a therapeutic good, or part of a therapeutic good.\n\nproprietary flavour means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing flavour to a therapeutic good, or part of a therapeutic good.\n\nproprietary fragrance means a formulation that is identified as a proprietary ingredient in TGA Business Services for the purpose of providing fragrance to a therapeutic good, or part of a therapeutic good.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nrelevant biological means a biological included in the Register.\n\nrelevant medicine means a medicine included in:\n\n(a) the part of the Register for goods known as registered goods; or\n\n(b) the part of the Register for goods known as listed goods.\n\nTGA Business Services means TGA Business Services on the Therapeutic Goods Administration website that may be accessed on the internet at https://business.tga.gov.au.\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\n (1) In relation to a relevant medicine, the kinds of therapeutic goods information mentioned in column 2 of the table in Part 1 of Schedule 1, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.\n\n (2) In relation to a relevant biological, the kinds of therapeutic goods information mentioned in column 2 of the table in Part 2 of 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\nSchedule 1—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\nPart 1—Medicines\n\n- Kinds of therapeutic goods information in relation to a relevant medicine\n- Column 1 Column 2 Column 3\n- Item Information Description\n- 1 active ingredients the name and amount of each active ingredient\n- 2 other ingredients the name of each other ingredient\n- 3 the presence of a proprietary colour where the relevant medicine contains a proprietary colour—the word “colour”\n- 4 the presence of a proprietary flavour where the relevant medicine contains a proprietary flavour—the word “flavour”\n- 5 the presence of a proprietary fragrance where the relevant medicine contains a proprietary fragrance—the word “fragrance”\n\n\n\n\n\nPart 2—Biologicals\n\n- Kinds of therapeutic goods information in relation to a relevant biological\n- Column 1 Column 2 Column 3\n- Item Information Description\n- 1 active components the name and amount of each active component\n- 2 other components the name of each other component\n- 3 the presence of a proprietary colour where the relevant biological contains a proprietary colour—the word “colour”\n- 4 the presence of a proprietary flavour where the relevant biological contains a proprietary flavour—the word “flavour”\n- 5 the presence of a proprietary fragrance where the relevant biological contains a proprietary fragrance—the word “fragrance”\n\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly focused on its original purpose: specifying exactly what ingredient and component information the TGA may release to the public. It has not expanded beyond this narrow information-disclosure function."},"complexity_factors":["Short instrument: only 5 operative sections plus a schedule with two simple tables","Minimal cross-referencing: only references to the parent Act (Therapeutic Goods Act 1989) and Regulations for standard definitions","Straightforward conditional logic: simple 'if present, then disclose' structure with no nested exceptions","Limited defined terms: 10 definitions in section 4, all clearly explained","No temporal or transitional provisions beyond basic commencement rule","Tabular format in Schedule 1 makes obligations immediately readable"],"plain_english_summary":"This law lets the Therapeutic Goods Administration publish ingredient information for medicines and biologicals registered in Australia: names and amounts of active ingredients/components, names of other ingredients, and a yes/no flag (\"colour\", \"flavour\", or \"fragrance\") if a proprietary formulation is present. It gives consumers and clinicians clearer information for safety and allergies while protecting companies’ secret formulations by withholding proprietary recipes."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument does not expand statutory powers; it specifies the kinds of therapeutic goods information that may be released under subsection 61(5C) of the Act for relevant medicines and biologicals included in the Register. It confines disclosure categories to active and other ingredients/components and flags for proprietary colour/flavour/fragrance, and applies to registered and listed goods as defined."},"complexity_factors":["Instrument is narrowly framed: it only specifies particular kinds of information (Schedule 1) rather than creating new powers (see section 5 and Schedule 1).","Relies on cross-references to the Therapeutic Goods Act 1989 (subsections 61(1), 61(5C), 61(5D)) and to definitions in the Act and Therapeutic Goods Regulations 1990 (see section 4), creating dependency on external text.","Distinguishes between medicines and biologicals and between 'active' vs 'other' ingredients/components, requiring correct classification by sponsors (definitions in section 4 and Schedule 1).","Identifies 'proprietary' colours/flavours/fragrances by reference to TGA Business Services, coupling operation to an external administrative list (section 4 definitions).","Decision to release information remains an administrative discretion under s61(5C) of the Act; this instrument only specifies what kinds of information may be released (see note after section 5).","Operational compliance burden is limited but depends on accuracy and maintenance of register entries by sponsors (mechanical data items listed in Schedule 1)."],"plain_english_summary":"Specifies which ingredient and component details for registered or listed medicines and biologicals may be released publicly from the TGA Register under subsection 61(5C) of the Therapeutic Goods Act. It lists names and amounts of active ingredients/components, names of other ingredients/components, and flags presence of proprietary colour, flavour or fragrance.\n\nAffected parties: product sponsors/manufacturers (who supply register data), the Therapeutic Goods Administration (which may release it), and members of the public seeking ingredient information."},"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-medicines-and-biologicals-ingredients-and-components-information-specification-202","history":"/api/acts/therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202/history","analysis":"/api/acts/therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202/analysis","conflicts":"/api/acts/therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202/conflicts","importantCases":"/api/acts/therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202/important-cases","documents":"/api/acts/therapeutic-goods-medicines-and-biologicals-ingredients-and-components-information-specification-202/documents"}}