Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For section 32AB of the Act:
(a) 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:
(i) applicable standards;
(ii) intended clinical use;
(iii) principal manufacturer; and
(b) 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:
(i) product name;
(ii) dosage form;
(iii) formulation or composition;
(iv) therapeutic indication;
(v) type of container, regardless of container size;
(vi) principal manufacturer; and
(c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:
(i) active ingredient;
(ii) dosage form;
(iii) principal manufacturer.
(1A) However, a biological is not separate and distinct from other biologicals under subregulation (1) if:
(a) 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
(b) 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.
(2) 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.