Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) The Secretary must consider the application.
(2) The Secretary must designate the medicine, in writing, as an orphan drug if the Secretary is satisfied that the statements made in the application are correct.
(3) The Secretary must refuse to designate the medicine as an orphan drug if the Secretary is not satisfied that all of the statements made in the application are correct.
(4) The Secretary must tell the applicant in writing, as soon as practicable after making the decision, whether the medicine has been designated.
Note There is no fee for making the Secretary's decision: see subregulation 45 (12).
(5) If the Secretary designates the medicine, the Secretary must publish a notice in the Gazette , as soon as practicable after making the decision, giving the following information:
(a) the sponsor's name;
(b) the medicine's dose form and indication;
(c) a statement that the medicine is a designated orphan drug.