Definitions
1 Definitions
In this table:
C1 (section 9D) application means a request made under subsection 9D(1), (2) or (3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C1 (section 9D) application.
C1 (section 23) 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 a C1 (section 23) application.
C2 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C2 (section 9D) application.
C2 (section 23) 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 a C2 (section 23) application.
C3 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C3 (section 9D) application.
C3 (section 23) 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 a C3 (section 23) application.
C4 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C4 (section 9D) application.
C4 (section 23) 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 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:
the strength, as recorded in the entry in the Register; or
the dosage, the recommended dose regimen or the maximum daily dose; or
the dosage form; or
the route of administration; or
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:
the formulation, composition or design specification; or
the container for the goods; or
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 chemical, biological or radiopharmaceutical substance that has not previously been included in the Register; or
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
a biological substance that, having previously been included in the Register, differs from the registered substance:
in having a different molecular structure; or
in deriving from source material of a different nature or from a different manufacturing process; or
a radiopharmaceutical substance that:
is a radionucleide or ligand that has not previously been included in the Register; or
has a coupling mechanism, linking the molecule and radionucleide, that has not previously been included in the Register; or
a fixed combination of active substances that have not previously been included in the Register as that fixed combination.
page means:
a legible photocopy of 1 side of 1 leaf of a published work, diagram or chart; or
in respect of any other work—1 side of 1 leaf (or a copy of 1 side of 1 leaf):
that has a maximum length of 297 millimetres and a maximum width of 210 millimetres; and
that has a left‑hand margin that is at least 25 millimetres in width; and
the information on which is typed or printed in legible characters at least 8 points in size; and
that, if it is part of a document exceeding 1 page in length—is paginated.
primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured.
For paragraph (a) of item 2A and items 2B, 2C, 2CA and 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 is taken to be a submission.
A person making more than 1 application of a kind mentioned in subclause (2), simultaneously, is taken to be making a submission that includes all of those applications if the goods concerned contain the same active ingredient.
This Act’s bill:Explanatory statement
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