Commonwealth Numbered Regulations

NATIONAL HEALTH (PHARMACEUTICALS AND VACCINES -- COST RECOVERY) REGULATIONS 2009 (SLI NO 372 OF 2009) - REG 2.10

                An application is in the minor category if:

                (a)    it is resubmitted under regulation 2.20; and

               (b)    it was previously evaluated by the Committee in the major category; and

                (c)    it does not include, in support of a request that was previously considered by the Committee, data that is:

                          (i)    a reconstruction of a modelled economic evaluation previously considered by the Committee; or

                         (ii)    a new methodological basis to support a variable in a modelled economic evaluation previously considered by the Committee; and

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

                (e)    if it includes a request that was not previously considered by the Committee -- that request does not satisfy the requirements for a major application under a provision in Subdivision 2.