Document ID: chunk:federal_register_of_legislation:C2025C00090:section:99acb:p3
Version: federal_register_of_legislation:C2025C00090
Segment Type: section
Provision Reference: s 99ACB (pt 3/5)
Character Range: 324288–326925

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 of a pharmaceutical item; and
 (b) the Minister has made a determination under section 99ACBA in relation to the new brand of the trigger item; and
 (c) the determination under section 99ACBA has not ceased to have effect.

First new brand price reduction
 (4) The Minister:
 (a) may, under section 85AD, make a price agreement for the new brand of the trigger item; and
 (b) must not make a determination under section 85B in relation to the new brand of the trigger item.
 (4A) If, on the day before the determination day:
 (a) the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or
 (b) if paragraph (a) does not apply—the original approved ex‑manufacturer price of the first listed brand of the existing item;
has, by virtue of previous price reductions, been reduced by:
 (c) 35% or less, subsection (5) applies; and
 (d) more than 35% but less than 60%, subsection (5A) applies.
Note: If previous price reductions have been 60% or more, see paragraph (2)(d).
 (4B) If the approved ex‑manufacturer price mentioned in paragraph (4A)(a) or (b) 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 paragraph 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.
 (5) Subject to subsections (6) and (6A), the agreed price of the new brand of the trigger item that comes into force on the determination day must not exceed the approved ex‑manufacturer price, on the day before the determination day, of the existing brand of the existing item, reduced by 25%.
 (5A) Subject to subsections (6) and (6A), the agreed price of the new brand of the trigger item that comes into force on the determination day must not exceed:
 (a) 40% of the approved ex‑manufacturer price of a listed brand of the existing item on 1 January 2016; or
 (b) if paragraph (a) does not apply—40% of the original approved ex‑manufacturer price of the first listed brand of the existing item.
 (5B) If the approved ex‑manufacturer price mentioned in paragraph (5A)(a) or (b) 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 paragraph is taken to be the amount