Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:11a
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 11A
Character Range: 173489–175249

11A  Characteristics that separate and distinguish certain biologicals from other biologicals
 (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.