Document ID: chunk:federal_register_of_legislation:F2024C00984:reg:43
Version: federal_register_of_legislation:F2024C00984
Segment Type: reg
Provision Reference: reg 43
Character Range: 85099–86054

43  Pricing applications in Pricing Pathway B category
 (1) A pricing application is in Pricing Pathway B category if:
 (a) the pricing application seeks the entering into of a deed under section 85E of the Act relating to the drugs or medicinal preparations to which the pricing application relates (the new drugs); and
 (b) no deed under that section is in force (between the Commonwealth and any person) that contains terms (the pricing terms) about the following:
 (i) reimbursing the Commonwealth;
 (ii) providing the Commonwealth with information;
  that are substantially similar to the pricing terms that are appropriate for the new drugs; and
 (c) the pricing application is not in Pricing Pathway A category.
Note: Section 45 is relevant to paragraph (b).
 (2) For the purposes of paragraph (1)(b), the pricing terms are appropriate for the new drugs if they are consistent with the Committee's recommendation or advice covering the new drugs.