Document ID: chunk:federal_register_of_legislation:C2014A00004:clause:5_8
Version: federal_register_of_legislation:C2014A00004
Segment Type: clause
Provision Reference: sch 5 cl 8
Character Range: 24037–24606

8  After subsection 25AA(4)
Insert:
 (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.