Characteristics that separate and distinguish certain biologicals from other biologicals
11A Characteristics that separate and distinguish certain biologicals from other biologicals
For section 32AB of the Act:
a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
applicable standards;
intended clinical use;
principal manufacturer; and
a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
product name;
dosage form;
formulation or composition;
therapeutic indication;
type of container, regardless of container size;
principal manufacturer; and
an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
active ingredient;
dosage form;
principal manufacturer.
However, a biological is not separate and distinct from other biologicals under subregulation (1) if:
the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and
the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.
In this regulation:
principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.
This Act’s bill:Explanatory statement
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