Commonwealth Consolidated Acts

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When the Secretary must not use protected information

  (1)   When evaluating therapeutic goods for registration, the Secretary must not use information about other therapeutic goods that is protected information.

  (2)   Information is protected information if:

  (a)   the information was given to the Secretary in relation to an application to register therapeutic goods (the new goods ) consisting of, or containing, an active component; and

  (b)   the information is about the active component and is not available to the public; and

  (c)   when the application to register the new goods was lodged:

  (i)   no other therapeutic goods consisting of, or containing, that active component were included in the Register; and

  (ii)   no such therapeutic goods had been included in the Register at any time before then; and

  (d)   the new goods became registered on or after the commencement of this subsection; and

  (e)   5 years have not passed since the day the new goods became registered; and

  (f)   the person in relation to whom the new goods are registered has not given the Secretary permission in writing for the Secretary to use the information.

  (3)   For the purposes of subsection   (2), an active component , in relation to therapeutic goods, is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods.

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