Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_99add
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 99ADD
Character Range: 66979–69237

99ADD  Mandatory compliance with the price disclosure requirements

Main case: listing of a new brand of a pharmaceutical item

 (1) A person is required to comply with the price disclosure requirements for each supply of a brand (the mandatory brand) of a pharmaceutical item (the mandatory item) if:
 (a) the person is the responsible person for the mandatory brand of the mandatory item; and
 (b) a determination under subsection 85(6) comes into force in relation to the mandatory brand of the mandatory item on a day (the determination day); and
 (c) on the day before the determination day, the mandatory brand was not a listed brand of the mandatory item; and
 (d) on the determination day, or on the day before that day:
 (i) a brand (the existing brand) of a pharmaceutical item (the existing item) is a listed brand of the existing item; and
 (ii) the mandatory brand of the mandatory item is bioequivalent or biosimilar to the existing brand of the existing item; and
 (iii) the mandatory item and existing item have the same drug and manner of administration.

Note: For the purposes of paragraph (d), the mandatory brand and the existing brand may be the same brand, or the mandatory item and the existing item may be the same pharmaceutical item.

Flow‑on case: effect of listing the mandatory brand on related brands

 (2) A person who is required under subsection (1) to comply with the price disclosure requirements for each supply of the mandatory brand of the mandatory item is also required to comply with the price disclosure requirements for each supply of every brand (the related brands) of every pharmaceutical item (the related items) if:
 (a) the person is the responsible person for the related brands of the related items; and
 (b) on the determination day, the related brands are listed brands of the related items; and
 (c) the mandatory item and related items have the same drug and manner of administration.

Note: The related brands may include the mandatory brand, and the related items may include the mandatory item.

When the price disclosure requirements start to apply

 (3) The person is required to comply with the price disclosure requirements under subsections (1) and (2) on and after the determination day.