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THERAPEUTIC GOODS REGULATIONS 1990 - REG 16K
Period during which designation is in force
(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.
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