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Therapeutic Goods Act 1989
23AAApplications for provisional registration of medicine
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#### 23AA Applications for provisional registration of medicine
(1) If:
(a) a person makes an application under section 23 for the registration of a medicine; and
(b) a provisional determination under section 22D relating to the person, the medicine and the indication to which the application relates is in force when the application is made;
then, for the purposes of this Act, the application is taken to be an application for provisional registration of the medicine.
(2) If:
(a) in accordance with subsection 29(2), a medicine (the original medicine) is provisionally registered because of an application by a person that, under subsection (1) of this section, is taken to be an application for provisional registration of the original medicine; and
(b) another medicine (the new medicine) is taken, under subsection 16(1), to be separate and distinct from the original medicine; and
(c) the person makes an application under section 23 for the registration of the new medicine; and
(d) the person makes the application before the end of the provisional registration period for the original medicine under subsection 29(3) (including that period as extended under subsection 29(6)); and
(e) the person specifies in the application that the person is seeking provisional registration of the new medicine; and
(f) at the time the person makes the application, the active ingredients of the new medicine are the same as the active ingredients of the original medicine; and
(g) at the time the person makes the application, the indications of the new medicine are the same as the indications of the original medicine;
then, for the purposes of this Act, the application is taken to be an application for provisional registration of the new medicine.