Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 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.



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