Commonwealth Numbered Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 2.11

                An application is in the minor category if:

                (a)    it includes a request that satisfies the requirements for a major application under a provision in Subdivision 2; and

               (b)    the request relates to a drug or medicinal preparation that is a medicinal food; and

                (c)    it is not possible for the applicant to comply with the requirement under regulation 2.6 to provide an economic evaluation because the patient population is too small; and

               (d)    no other request in the application:

                          (i)    relates to a drug or medicinal preparation that is not a medicinal food; and

                         (ii)    meets the criteria for a major application under a provision in Subdivision 2.