Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 16K

             (1)  A designation under regulation 16J of a medicine as an orphan drug:

                     (a)  comes into force when it is made; and

                     (b)  remains in force for a period of 6 months.

             (2)  Subregulation (1) has effect subject to regulations 16L and 16M.