Commonwealth Numbered Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 3.4

                An application is in the simple pricing category if:

                (a)    regulation 3.3 does not apply to the application; and

               (b)    when the application was made, it included:

                          (i)    a claim that the effectiveness of a specified dose of a drug, medicinal preparation or vaccine the subject of the application is equivalent to the dose of a listed drug, special pharmaceutical product, or designated vaccine; and

                         (ii)    a claim of cost minimisation; and

                (c)    the Committee's recommendation or advice to the Minister was in accord with the claims; and

               (d)    the resulting price is based on the claims.