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.