{"id":"F2022L00758","name":"Therapeutic Goods (Prescription Medicines—Kind of Information that Must Accompany Application for Registration) Determination 2022","slug":"therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441396,"registerId":"F2022L00758-fast-fetch-1775956708010","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Prescription Medicines—Kind of Information that Must Accompany Application for Registration) Determination 2022","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\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—Kind of Information that Must Accompany Application for Registration) Determination 2022\n\nI, Nick Henderson, as delegate of the Secretary of the Department of Health, make the following determination.\n\nDated 9 June 2022\n\nNick Henderson\n\nActing First 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  Application\n\n6  Kind of information\n\nSchedule 1—Prescription Medicines\n\n1  Name\n\n  This instrument is the Therapeutic Goods (Prescription Medicines—Kind of Information that Must Accompany Application for Registration) Determination 2022.\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The day after this instrument is registered.\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 23B(9) 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) medicine;\n\n(b) Register;\n\n(c) registered goods.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nbiosimilar means a medicine that is a biosimilar in relation to a registered medicine.\n\nextension of indications medicine means a medicine that:\n\n (a) contains the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine included in the Register; and\n\n (b) has one or more indications in addition to that other medicine.\n\ngeneric product has the same meaning as in the Regulations.\n\nmajor variation has the same meaning as in clause 1 of Schedule 9 to the Regulations.\n\nmajor variation medicine means a medicine that is taken to be separate and distinct from a registered medicine because of a major variation but does not include:\n\n (a) a new chemical entity medicine; or\n\n (b) a new biological entity medicine; or\n\n (c) a new biosimilar medicine; or\n\n (d) a new combination medicine; or\n\n (e) an extension of indications medicine; or\n\n (f) a new generic medicine; or\n\n (g) a new trade name medicine.\n\nnew biological entity medicine means a medicine that:\n\n (a) has not previously been included in the Register, and contains a biological substance; or\n\n (b) contains a biological substance mentioned in paragraph (c) of the definition of new chemical entity.\n\nnew biosimilar medicine means a medicine that has not previously been included in the Register and is a biosimilar in relation to a registered medicine.\n\nnew chemical entity has the same meaning as in clause 1 of Part 1 of Schedule 9 to the Regulations.\n\nnew chemical entity medicine means a medicine that contains a new chemical entity as mentioned in paragraphs (a), (b) and (d) of the definition of new chemical entity.\n\nnew combination medicine means a medicine that contains a new chemical entity as mentioned in paragraph (e) of the definition of new chemical entity.\n\nnew generic medicine means a medicine that has not previously been included in the Register and is a generic product.\n\nnew trade name medicine means a medicine that:\n\n (a) has the same active ingredient or active ingredients (or fixed combination of active ingredients) as a registered medicine; and\n\n (b) has the same indications as that other medicine; and\n\n (c) has the same dosage form as that other medicine; and\n\n (d) has been given a different name to that other medicine by the manufacturer, under which the medicine will be supplied.\n\nregistered medicine means a medicine that is included in the part of the Register for goods known as registered goods.\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nTherapeutic Goods Administration has the same meaning as in the Regulations.\n\n5  Application\n\n  This instrument applies to medicines of the class specified in paragraph 4(1)(a) of the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018, as in force or existing at the commencement of this instrument.\n\nNote: The Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018 is a notifiable instrument and is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au/).\n\n6  Kind of information\n\n  For the purposes of subparagraph 23B(2)(d)(i) of the Act, an application for the registration of a medicine mentioned in Schedule 1 must be accompanied by information of the following kind:\n\n (a) the information specified for the medicine in the document titled CTD Module 1: Administrative information and prescribing information for Australia (Version 4.3, December 2020) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument; and\n\n (b) the information specified for the medicine in the document titled Mandatory requirements for an effective application (Version 4.1, June 2022) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\nNote: The documents mentioned in paragraphs (a) and (b) are published at www.tga.gov.au.\n\n\n\n\nSchedule 1—Prescription Medicines\n\nNote: See section 6.\n\n \n\n- Prescription medicines\n- Column 1 Column 2\n- Item Prescription medicines\n- 1 new chemical entity medicine\n- 2 new biological entity medicine\n- 3 new biosimilar medicine\n- 4 new combination medicine\n- 5 extension of indications medicine\n- 6 major variation medicine\n- 7 new generic medicine\n\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: specifying documentation requirements for prescription medicine registration applications. The detailed categorisation of medicine types (new chemical entities, biosimilars, generics, etc.) serves the core function of ensuring appropriate information accompanies each application type, rather than expanding beyond this administrative purpose."},"complexity_factors":["14 defined terms in section 4, many of which cross-reference other legislation (Therapeutic Goods Regulations 1990 and the parent Act)","Nested definitions: terms like 'major variation medicine' are defined by exclusion of six other defined categories, creating interdependent definitions","Multiple external document references: the core obligation in section 6 depends on two separate TGA documents (CTD Module 1 and Mandatory requirements) that exist outside the legislative text","Schedule 1 operates as a lookup table requiring cross-referencing with section 6 to determine actual obligations","Conditional commencement provisions with table-based structure (though standard for legislative instruments)"],"plain_english_summary":"This Determination sets a mandatory checklist of paperwork pharmaceutical companies must file to register prescription medicines on the Australian Register of Therapeutic Goods. It applies to sponsors seeking approval and to the TGA that assesses them, and indirectly affects clinicians and patients.\n\nBy requiring specific TGA documents and standardised submissions, it helps ensure complete, consistent applications so medicines can be evaluated efficiently for safety, efficacy and correct labelling."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"This instrument does not expand or narrow the classes of goods beyond those it lists. It applies to the prescription medicine classes identified in Schedule 1 and to medicines within the class in paragraph 4(1)(a) of the Classes instrument (see s5 and Schedule 1). Its effect is to prescribe the kind of information that must accompany an application for registration under subparagraph 23B(2)(d)(i) of the Act (see s6), using specific TGA guidance versions rather than altering the statutory scope of registrable goods."},"complexity_factors":["Cross-references to primary legislation and other instruments (Therapeutic Goods Act 1989; Therapeutic Goods Regulations 1990; Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018) (see s3, s5, Definitions).","Dependence on external TGA documents by title and version (CTD Module 1 v4.3 Dec 2020; Mandatory requirements v4.1 June 2022) that applicants must supply (see s6(a)–(b)).","Multiple technical categories and definitions that determine coverage (new chemical entity, new biological entity, new biosimilar, new combination, extension of indications, major variation, new generic) requiring correct classification by applicants (see Definitions and Schedule 1).","Instrument made by a departmental delegate under the Act, concentrating authorising power in the Secretary’s delegate and linking enforcement to the Act’s registration provisions (see heading and s3).","Commencement and version-freezing language that fixes the required document versions as at the instrument’s start date (see s2(1) and s6(a)–(b)), affecting update mechanisms for future guidance.","Legal hook is a specific subparagraph of the Act (subparagraph 23B(2)(d)(i)), so the instrument modifies the information required for statutory registration rather than creating new substantive registration criteria (see s6 introductory text).","Practical compliance burden: applicants must prepare regulatory-standard CTD administrative modules and satisfy mandatory application checklists, which can be document- and resource-intensive (implied by s6(a)–(b))."],"plain_english_summary":"This determination requires sponsors applying to register certain prescription medicines to submit specific administrative and application documents. It covers categories such as new chemical, biological, biosimilar, combination, extension-of-indication, major-variation and new generic medicines. \n\nIt makes two named TGA guidance documents mandatory attachments to an application, shifting the compliance task to applicants and tying the information standard to the TGA’s registration process."},"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"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg","history":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg/history","analysis":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg/analysis","conflicts":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg/conflicts","importantCases":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg/important-cases","documents":"/api/acts/therapeutic-goods-prescription-medicines-kind-of-information-that-must-accompany-application-for-reg/documents"}}