Document ID: chunk:federal_register_of_legislation:C2024C00632:section:19:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 19 (pt 2/4)
Character Range: 137338–139999

of the reasons for the decision.
 (4A) The use by a person for experimental purposes in humans of specified therapeutic goods that are the subject of an approval granted to someone else under paragraph (1)(b) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:
 (a) the preconditions on the use of the goods for those purposes;
 (b) the principles to be followed in the use of the goods for those purposes;
 (c) the monitoring of the use, and the results of the use, of the goods for those purposes;
 (d) the circumstances in which the person must cease the use of the goods for those purposes.
 (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.
 (5) The Secretary may, in writing, authorise a specified medical practitioner to supply:
 (a) specified therapeutic goods for use in the treatment of humans; or
 (b) a specified class of such goods;
to the class or classes of recipients specified in the authority.
 (5AA) An application for an authority under subsection (5) must be in a form (if any) approved, in writing, by the Secretary.
 (5A) An authority may be given subject to the conditions (if any) specified in the authority.
 (5B) The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).