Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The sponsor of an orphan drug may apply to the Secretary for the medicine to be designated as an orphan drug.
(2) The application must be made using an application form approved by the Secretary.
(3) The application must show why the medicine is an orphan drug.
(4) For a vaccine or in vivo diagnostic agent, the application must also state that the vaccine or agent will be administered in Australia to not more than 2,000 people in each year after it is registered for use for the disease or condition.
Note There is no fee for making the application: see subregulation 45 (12).