Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 32EE

Imposition or variation or removal of conditions after biological included in the Register

             (1)  The Secretary may, by notice in writing given to the person in relation to whom a biological is included in the Register, impose new conditions on the inclusion or vary or remove conditions imposed under section 32ED or this subsection.

             (2)  The Secretary's power under subsection (1) may be exercised at the request of the person concerned or on the Secretary's own initiative. A request must be accompanied by the prescribed fee.

             (3)  The imposition or variation or removal of a condition under subsection (1) takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or

                    (aa)  in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

                   (ab)  in the case of a removal to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 28 days after the notice is given to the person, unless the person has agreed to an earlier day; or

                     (b)  in any other case--on a later day specified in the notice, being a day not earlier than 28 days after the notice is given to the person.

          (3A)  For the purposes of paragraphs (3)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.

             (4)  A notice under subsection (1) is not a legislative instrument.



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