Document ID: chunk:federal_register_of_legislation:F2025C00146:reg:4
Version: federal_register_of_legislation:F2025C00146
Segment Type: reg
Provision Reference: reg 4
Character Range: 2406–3533

4  Originator Brand
 (1) For subsection 99ADB(6B) of the Act, unless subsections (2) or (3) of this section apply, an originator brand specified in column 3 of an item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2 of the same item in Schedule 1.
 (2) Where a manner of administration is specified in column 4 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 1, with the manner of administration specified in column 4 of the same item in Schedule 1.
 (3) Where a form is specified in column 5 of an item in Schedule 1, an originator brand specified in column 3 of that item in Schedule 1 is an originator brand for all brands of pharmaceutical item containing the drug specified in column 2, with the manner of administration specified in column 4 in the form specified in column 5 of the same item in Schedule 1.
 Note: A brand of an exempt item is not an originator brand due to section 99ADA of the Act.