Document ID: chunk:federal_register_of_legislation:F2024C00988:reg:84
Version: federal_register_of_legislation:F2024C00988
Segment Type: reg
Provision Reference: reg 84
Character Range: 145099–146845

84  Originator brands
 (1) Information provided under section 85 about an originator brand must not be taken into account if:
 (a) on the first day of each calendar month in the data collection period (from its beginning in relation to the originator brand) on which the originator brand is a listed brand, there is another listed brand of pharmaceutical item that:
 (i) is not an originator brand; but
 (ii) has the same pharmaceutical item as the originator brand; and
 (b) at the end of the previous data collection period either:
 (i) the drug in the WADP brand had been on F2 for at least 18 months and during that period there has been no price reduction under Division 3B of Part VII of the Act to any brand of pharmaceutical item that has the same drug and manner of administration as the WADP brand; or
 (ii) the drug in the WADP brand had been on F2 for at least 30 months; and
 (c) on a day at least as many months as mentioned in subparagraph (b)(i) or (ii) (whichever is applicable) before the end of the previous data collection period:
 (i) there was a related brand of the WADP brand that had the same pharmaceutical item as, or was bioequivalent or biosimilar to, the WADP brand; or
 (ii) there were 2 or more related brands of the WADP brand that had the same pharmaceutical item as, or were bioequivalent or biosimilar to, each other.
 (2) Paragraph (1)(a) has effect even if the other listed brand is different from month to month.
 (3) However, subsection (1) does not apply if taking the information into account would result in a higher weighted average percentage difference under section 80 (weighted average percentage difference for the WADP brand and all related brands).

Subdivision D—Price disclosure requirements