THERAPEUTIC GOODS ACT 1989 - SECT 22D Provisional determinations

THERAPEUTIC GOODS ACT 1989 - SECT 22D

  (1)   If a person makes an application, in accordance with subsection   22C(2), for a provisional determination relating to a medicine, the Secretary must decide to make, or to refuse to make, the determination.

Criteria

  (2)   The Secretary may make the determination if the Secretary is satisfied that the criteria prescribed by the regulations for the purposes of this subsection are met in relation to the medicine.

Content of determination

  (3)   The determination must specify:

  (a)   the person to whom the determination relates; and

  (b)   the medicine to which the determination relates; and

  (c)   the indication of the medicine to which the determination relates; and

  (d)   each active ingredient of the medicine to which the determination relates.

The determination may specify any other matters that the Secretary considers appropriate.

Notice of decision

  (4)   As soon as practicable after making the decision, the Secretary must:

  (a)   give the person written notice of the decision; and

  (b)   if the Secretary refuses to make the determination--set out the reasons for the refusal in the notice.