Therapeutic Goods Regulations 1990

The Secretary may, by written notice given to the sponsor of a designated orphan drug, revoke the designation:

on application by the sponsor; or

if the Secretary is satisfied that:

if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or

if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.

Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.