Document ID: chunk:federal_register_of_legislation:C2024C00632:section:29:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 29 (pt 3/3)
Character Range: 303634–305704

period—set out the reasons for the refusal in the notice.
Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3).
 (8) No more than 2 extensions may be granted in relation to a medicine on applications under subsection (4).
Note: Under subsection (9) the Secretary may extend the provisional registration period on his or her own initiative.
 (8A) The Secretary must not, under subsection (6A), extend the provisional registration period applicable under subsection (3A) for the new medicine so that period would end more than 6 years after the provisional registration for the original medicine concerned commenced.

Effect on provisional registration of later section 23 application
 (9) If:
 (a) before the provisional registration period ends, the person in relation to whom the medicine is provisionally registered makes an application under section 23 for registration of the medicine; and
 (b) the application is for the medicine to be included in the part of the Register for goods known as registered goods;
then the Secretary may, in connection with the application, end or extend the provisional registration period as the Secretary considers appropriate.
Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3).
 (10) In ending or extending, under subsection (9), the provisional registration period:
 (a) the Secretary must have regard to any matters prescribed by the regulations for the purposes of this paragraph; and
 (b) the Secretary must ensure the provisional registration period continues while the Secretary is considering the application, unless the medicine's registration is cancelled under this Part; and
 (c) the Secretary must not extend the provisional registration period so it would end more than 6 years after the provisional registration commenced, unless the extension is for the purposes of paragraph (b).