Document ID: chunk:federal_register_of_legislation:C2024C00632:section:25aa:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 25AA (pt 2/2)
Character Range: 224430–226720

takes effect, a person made an application to include medicine in the Register; and
 (b) before that day and in relation to that application, the Secretary, in a notice given under subsection 25(4) (as in force on that day) to the person, specified the product information that was approved by the Secretary in relation to the medicine; and
 (c) on or after that day and in relation to that application, the Secretary includes the medicine in the Register in relation to the person;
then that product information (including as varied before that inclusion) is, on and after the day the registration of the medicine commences, the product information that is approved under this section in relation to the medicine.
Note: Subsection (4) deals with variation of the product information.

Variations
 (4) If:
 (a) there is medicine included in the Register in relation to a person and there is product information approved under this section in relation to the medicine; and
 (b) either:
 (i) under section 9D, the Secretary varies the entry in the Register in relation to the medicine; or
 (ii) there is a change in the conditions to which the inclusion of the medicine is subject; and
 (c) as a result of that variation or change, the Secretary is satisfied that a variation to that product information is required;
the Secretary may, by notice in writing given to the person, make any variations that the Secretary considers appropriate to the product information that is approved in relation to the medicine.
 (4A) Without limiting subsection (4), a variation to the product information is not appropriate unless:
 (a) if subparagraph (4)(b)(i) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 9D to vary the entry in the Register in relation to the medicine; or
 (b) if subparagraph (4)(b)(ii) applies—the product information, as varied, reflects the basis on which the Secretary decided under section 28 to change the conditions to which the inclusion of the medicine is subject.
 (5) To avoid doubt, if product information that is approved in relation to medicine is varied under this section, that product information, as varied, becomes the product information that is approved under this section in relation to the medicine.