Document ID: chunk:federal_register_of_legislation:F2024C00988:reg:69
Version: federal_register_of_legislation:F2024C00988
Segment Type: reg
Provision Reference: reg 69
Character Range: 125365–127781

69  Special rules for certain listed brands
 (1) Subsections (3), (4) and (5) apply to a listed brand of a pharmaceutical item if:
 (a) paragraphs 99ADB(3B)(a) and (b) of the Act apply to the listed brand; and
 (b) a weighted average disclosed price does not exist for another listed brand of the same pharmaceutical item for the data collection period.
 (2) Subsections (4) and (5) apply to a listed brand of a pharmaceutical item if:
 (a) the start day for the listed brand is the relevant day; and
 (b) a weighted average disclosed price does not exist for another listed brand of the same pharmaceutical item for the data collection period.

Approved ex‑manufacturer price on relevant day
 (3) For the purposes of paragraph 99ADB(3B)(c) of the Act, the approved ex‑manufacturer price of the listed brand of the pharmaceutical item on the relevant day is the approved ex‑manufacturer price of the brand on the start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:
 (a) starting on the relevant day; and
 (b) ending immediately before the brand's start day.

Deemed data collection period and approved ex‑manufacturer price for determining weighted average disclosed price
 (4) For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision B, the brand is taken to have had a data collection period:
 (a) beginning on the earliest day on which the data collection period began for any related brand of the listed brand; and
 (b) ending on the day before the relevant day.
 (5) For the purpose of determining the weighted average disclosed price of the listed brand under Subdivision B, the approved ex‑manufacturer price of the listed brand on a price sampling day is taken to have been the approved ex‑manufacturer price of the listed brand on the brand's start day minus any amount that would have been added, and plus any amount that would have been deducted, because of a price adjustment, had the brand been a listed brand in the period:
 (a) starting on the price sampling day; and
 (b) ending immediately before the brand's start day.
Note: This enables an average approved ex‑manufacturer price to be worked out for the purpose of determining the weighted average disclosed price.

Subdivision B—Weighted average disclosed price