THERAPEUTIC GOODS ACT 1989 - SECT 28A Certification of manufacturing steps outside Australia following application for listing

THERAPEUTIC GOODS ACT 1989 - SECT 28A

  (1)   The person in relation to whom medicine is listed under section   26A or 26AE may apply to the Secretary for a certification under this section of a step in the manufacture of the medicine that is to be carried out outside Australia.

Note:   The listing of medicine is subject to the condition that each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection   26A(3) or subsection   (2) of this section: see subsection   28(5B).

  (2)   If an application is made to the Secretary under this section, the Secretary may, by writing, certify that the manufacturing and quality control procedures used in that step are acceptable. The Secretary must give the person written notice of the certification.

  (3)   In deciding whether to give the certification:

  (a)   subsection   26A(4) applies in a way corresponding to the way in which it applies for the purposes of subsection   26A(3); and

  (b)   subsection   26AB(5) applies in a way corresponding to the way in which it applies for the purposes of subsection   26AB(4).