Document ID: chunk:federal_register_of_legislation:C2020A00075:clause:3_3
Version: federal_register_of_legislation:C2020A00075
Segment Type: clause
Provision Reference: sch 3 cl 3
Character Range: 11262–12617

3  After subsection 19(4A)
Insert:
 (4B) If:
 (a) the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(b); and
 (b) the person requests the Secretary to do either or both of the following:
 (i) vary the therapeutic goods specified in the approval;
 (ii) vary the conditions imposed under subsection (1) on the approval; and
 (c) the request is in a form (if any) approved, in writing, by the Secretary; and
 (d) the request is accompanied by such information relating to the therapeutic goods as is required by the Secretary; and
 (e) the request is accompanied by the fee prescribed by the regulations;
the Secretary must, by notice in writing, vary or refuse to vary the approval. Any variation may be different than the variation requested and may involve imposing new conditions on the approval or varying or removing existing conditions.
 (4C) The Secretary must notify the person making the request under subsection (4B) of:
 (a) the Secretary's decision on the request; and
 (b) for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision.
 (4D) A variation under subsection (4B) takes effect at the time the Secretary notifies the person under subsection (4C) of the variation.