{"id":"F2021L01466","name":"Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021","slug":"therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":102139,"registerId":"commonwealth-F2021L01466-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Determination 2021.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under subsection 23B(10) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n (a) biological;\n (b) medicine;\n (c) Register;\n (d) registered goods.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> biosimilar means a medicine that is a biosimilar in relation to a registered medicine.\n\n> eCTD means the electronic Common Technical Document standard format, including:\n\n (a) Module 1 in accordance with eCTD AU module 1 and regional information v3.2, as in force or existing on 1 April 2025; and\n (b) Modules 2 to 5 in accordance with ICH eCTD Specification v3.2.2, as in force or existing on 1 April 2025.\n\nNote: The eCTD AU module 1 and regulation information v3.2 is published by the TGA on the TGA website at www.tga.gov.au. The ICH eCTD Specification v3.2.2. is published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and is available at www.ich.org.\n\n> extension 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 (b) has one or more indications in addition to that other medicine.\n\n> generic product has the same meaning as in the Regulations.\n\n> major variation has the same meaning as in clause 1 of Schedule 9 to the Regulations.\n\n> major 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 (b) a new biological entity medicine; or\n (c) a new biosimilar medicine; or\n (d) a new combination medicine; or\n (e) an extension of indications medicine; or\n (f) a new generic medicine; or\n (g) a new trade name medicine.\n\n> new 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 (b) contains a biological substance mentioned in paragraph (c) of the definition of new chemical entity.\n\n> new 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\n> new chemical entity has the same meaning as in clause 1 of Part 1 of Schedule 9 to the Regulations.\n\n> new 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\n> new combination medicine means a medicine that contains a new chemical entity as mentioned in paragraph (e) of the definition of new chemical entity.\n\n> new generic medicine means a medicine that has not previously been included in the Register and is a generic product.\n\n> new 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 (b) has the same indications as that other medicine; and\n (c) has the same dosage form as that other medicine; and\n (d) has been given a different name to that other medicine by the manufacturer, under which the medicine will be supplied.\n\n> registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.\n\n> Regulations means the Therapeutic Goods Regulations 1990.\n\n> Therapeutic Goods Administration has the same meaning as in the Regulations.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Application","content":"#### 5 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.\n\n> Note: 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.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Form of information","content":"#### 6 Form of information\n\n For the purposes of subparagraph 23B(2)(d)(ii) of the Act, the information in an application dossier, that accompanies an application for the registration of a medicine mentioned in Schedule 1, must be in:\n (a) the eCTD format; or\n (b) if exceptional circumstances exist—another format with the prior written agreement of the Therapeutic Goods Administration.","sortOrder":4},{"sectionNumber":"7","sectionType":"section","heading":"Application, savings and transitional provisions","content":"#### 7 Application, savings and transitional provisions\n\n This instrument, as in force immediately before the amendments made by the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025, continues to apply to applications for registration made before 1 October 2025.\n\n \n\nSchedule 1—Prescription Medicines\n\nNote: See section 6.\n\n```html\n

Prescription medicines

Column 1

Column 2

Item

Prescription medicines

1

new chemical entity medicine

2

new biological entity medicine

3

new biosimilar medicine

4

new combination medicine

5

extension of indications medicine

6

major variation medicine

7

new generic medicine

\n```","sortOrder":5}],"analysis":{"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"},"kimi_summary":{"content_quality":"ok","complexity_score":5,"scope_assessment":{"changed":false,"description":"The legislation appears to maintain its original scope as a technical procedural instrument governing application formats for prescription medicine registration. The 2025 amendments referenced in section 7 appear to be updates to technical standards (eCTD versions) and transitional arrangements rather than expansion into new substantive areas."},"complexity_factors":["14 defined terms in section 4, many of which are nested or cross-refer to other legislation (e.g., 'new chemical entity' refers to Schedule 9 of the Regulations)","Multiple overlapping categories of medicines with subtle distinctions (e.g., 'new biosimilar medicine' vs 'biosimilar', 'major variation medicine' with 7 explicit exclusions)","External technical standards incorporated by reference (eCTD AU module 1 v3.2 and ICH eCTD Specification v3.2.2 as at 1 April 2025)","Cross-references to the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Classes of Therapeutic Goods) Instrument 2018","Conditional exception in section 6 ('exceptional circumstances') requiring prior written agreement","Transitional provision in section 7 with date-specific application"],"plain_english_summary":"This law prescribes the document format companies must use to register prescription medicines in Australia, generally requiring the international eCTD electronic submission standard unless the TGA grants a written exception for exceptional circumstances. It affects pharmaceutical applicants for new drugs, biologics, biosimilars, new uses or major changes, and generics. It standardises reviews, aligns Australia with global practice, and preserves earlier rules for applications made before 1 October 2025."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"Clause 7 preserves the instrument as it existed immediately before the Therapeutic Goods (Prescription Medicines—Information Accompanying Applications for Registration) Amendment Determination 2025 for applications made before 1 October 2025, indicating the 2025 amendment alters the instrument's scope for later applications while earlier applications remain subject to the prior version (s7)."},"complexity_factors":["Technical specification requirement: precise eCTD versions and modules are mandated (s4, s6).","Multiple defined medicine categories (new chemical/biological/biosimilar/generic/combination/extension/major variation/new trade name) increase classification complexity (s4, Sch 1).","Discretionary exception: TGA may permit alternate formats in 'exceptional circumstances' requiring prior written agreement (s6).","Transitional provision referencing a later amendment (2025) with a cut‑off date for applications adds time‑based scope complexity (s7).","Cross‑references to the Act and Regulations for core terms and authorities require users to consult multiple instruments (s3, s4, references to Regulations and Act)."],"plain_english_summary":"This instrument requires applicants seeking registration for specified prescription medicines to submit their application dossier in the electronic Common Technical Document (eCTD) format, with the Therapeutic Goods Administration able to allow a different format in exceptional circumstances (s6). It covers the prescription-medicine categories listed in Schedule 1 and defines the eCTD versions and medicine-type terms used (s4, s5, Sch 1). The compliance burden falls on sponsors who prepare dossiers; the TGA has discretion to approve exceptions."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete","history":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete/history","analysis":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete/analysis","conflicts":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete/conflicts","importantCases":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete/important-cases","documents":"/api/acts/therapeutic-goods-prescription-medicines-information-accompanying-applications-for-registration-dete/documents"}}