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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