Document ID: chunk:federal_register_of_legislation:F2025C00036:clause:9_1:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: clause
Provision Reference: sch 9 cl 1 (pt 2/3)
Character Range: 646033–648781

by the Secretary under paragraph 23B(2)(a) of the Act for a C4 (section 23) application.
haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self‑renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage‑restricted progenitor cells.
major variation, for therapeutic goods of a particular kind, means a change to:
 (a) the strength, as recorded in the entry in the Register; or
 (b) the dosage, the recommended dose regimen or the maximum daily dose; or
 (c) the dosage form; or
 (d) the route of administration; or
 (e) the intended patient group.
minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to:
 (a) the formulation, composition or design specification; or
 (b) the container for the goods; or
 (c) any other attribute of the goods that results in the goods being separate and distinct.
N1 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N1 application.
N2 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N2 application.
N3 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N3 application.
N4 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N4 application.
N5 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N5 application.
new chemical entity means:
 (a) a chemical, biological or radiopharmaceutical substance that has not previously been included in the Register; or
 (b) an isomer, mixture of isomers, complex of, derivative of or salt of, a registered chemical substance that, having previously been included in the Register, differs from the registered substance in having different safety or efficacy properties; or
 (c) a biological substance that, having previously been included in the Register, differs from the registered substance:
 (i) in having a different molecular structure; or
 (ii) in