Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99acb:p2
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ACB (pt 2/5)
Character Range: 321935–324486

reduced by 60% or more.
 (2A) If the approved ex‑manufacturer price mentioned in subparagraph (2)(d)(i) or (ii) is by reference to a different pricing quantity than the pricing quantity on the day before the determination day, the approved ex‑manufacturer price mentioned in that subparagraph is taken to be the amount that the approved ex‑manufacturer price would have been had the pricing quantity been the same as the pricing quantity on the day before the determination day.
 (3) This section does not apply in relation to the new brand of the trigger item if:
 (a) any of the following has applied:
 (i) subsection (5) or (5A);
 (ia) a determination under paragraph (6A)(b);
 (ib) subsection 99ACF(1) or (2) because of item 4A, 4B or 8 in the table in subsection 99ACF(1);
 (ii) subsection 99ACF(1) or (2) because of repealed section 99ACH;
 (iii) repealed subsection 99ACF(2AB) or (2AC);
 (iv) section 99ACQ;
 (v) subsection 99ACR(3) or (4);
in relation to:
 (b) the new brand, or another listed brand, of the trigger item; or
 (c) a listed brand of another pharmaceutical item that has the same drug and manner of administration as the new brand of the trigger item; or
 (d) if the drug that is in the trigger item is in a therapeutic group—a listed brand of a pharmaceutical item that:
 (i) has another drug that is in that group; and
 (ii) has the same manner of administration as the new brand of the trigger item.
Note: For the purposes of subparagraph (a)(i), subsections (5) and (5A) of this section are taken not to have applied in relation to a brand of a pharmaceutical item in some cases: see section 99AEI and subsection (6B) of this section.
 (3A) This section does not apply in relation to the new brand of the trigger item if:
 (a) the new brand of the trigger item is a new presentation of an existing listed brand of a pharmaceutical item; and
 (b) the determination day in relation to the new brand of the trigger item is on or before the fifth anniversary of the drug in the pharmaceutical item being on F1; and
 (c) the responsible person for the new brand of the trigger item is the same person as the responsible person for the existing listed brand of the pharmaceutical item; and
 (d) either of the following apply:
 (i) there is not another brand of the pharmaceutical item that has the drug that is a listed brand;
 (ii) the drug is not on F2.
 (3B) This section does not apply in relation to the new brand of the trigger item if:
 (a) the new brand of the trigger item is a new presentation of an existing listed brand