Commonwealth Numbered Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 3.1

                This Part applies to an application mentioned in Subdivision 2 or 3 of Part 2, or regulation 2.12 or 2.13, if:

                (a)    the Committee advises or makes a recommendation to the Minister; and

               (b)    the advice or recommendation results in:

                          (i)    the Minister making or varying a price agreement with the applicant under section 85AD of the Act; or

                         (ii)    the Minister making a price determination under section 85B of the Act; or

                         (iii)    the Minister arranging for a price for which a designated vaccine may be supplied under section 9B of the Act; or

                        (iv)    the Minister making or varying an agreement with the applicant about the price of a special pharmaceutical product for its supply under section 100 of the Act.

Note    There are no fees payable under these Regulations for price agreements and determinations being made as a result of applications in the new brand of existing pharmaceutical item evaluation category: see regulation  2.18.