Document ID: chunk:federal_register_of_legislation:C2014A00004:clause:5_5
Version: federal_register_of_legislation:C2014A00004
Segment Type: clause
Provision Reference: sch 5 cl 5
Character Range: 23121–23873

5  Subsection 25AA(1)
Repeal the subsection, substitute:
 (1) The Secretary must approve product information in relation to therapeutic goods if:
 (a) the Secretary decides, under subsection 25(3), to register the goods; and
 (b) the goods are:
 (i) restricted medicine; or
 (ii) medicine in respect of which the applicant has been given a notice of the kind referred to in subparagraph 25(1)(da)(ii).
Note: Subsection (4) deals with variation of the product information.
 (1A) However, the Secretary must not approve product information in relation to therapeutic goods under subsection (1) unless the Secretary is satisfied that the product information reflects the basis on which the Secretary decided under subsection 25(3) to register the goods.