Department of Health
The Department of Health will remake without amendment the Therapeutic Goods Act 1989 – Determination under subsection 19A(3). The Determination contains a list of 9 countries. The Secretary is able to approve the importing or supply of an unapproved medicine (in the event of a shortage or lack of supply of a medicine that has been registered by the Therapeutic Goods Administration) if, amongst other things the unapproved medicine has been approved for general marketing in one of those countries. In line with the Australian Government best practice regulation requirements for sunsetting legislative instruments, the Department of Health has assessed the operation of this instrument, in consultation with affected stakeholders, and has certified that the instrument is operating efficiently and effectively. Therefore the Office of Best Practice Regulation notes that a Regulation Impact Statement is not required for the Regulations to be remade. As the instrument was remade without amendments there are no compliance cost changes.
