Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 30EFA

Reporting changes to the period of a shortage

  (1)   A person who has notified the period of a shortage of a medicine in Australia in accordance with section   30EF or this section must notify the Secretary of any change to that period. The person must do so:

  (a)   if the shortage was first required to be notified in accordance with paragraph   30EF(1)(a)--as soon as possible, but no later than 2 working days, after the first day the person knows, or ought reasonably to have known, of the change to that period; or

  (b)   in any other case--before the end of 10 working days beginning on the first day the person knows, or ought reasonably to have known, of the change to that period.

Reporting the resolution of a shortage

  (2)   A person who has notified the period of a shortage of a medicine in Australia in accordance with section   30EF or this section must notify the Secretary of any resolution of the shortage. The person must do so:

  (a)   if the shortage was first required to be notified in accordance with paragraph   30EF(1)(a)--as soon as possible, but no later than 2 working days, after the first day the person knows, or ought reasonably to have known, that the period of the shortage has ended; or

  (b)   in any other case--before the end of 10 working days beginning on the first day the person knows, or ought reasonably to have known, that the period of the shortage has ended.

Notification requirements

  (3)   A notification under subsection   (1) or (2) must:

  (a)   be in accordance with a form that is approved, in writing, by the Secretary; and

  (b)   for a notification under subsection   (1)--specify the period of the shortage of the medicine in Australia; and

  (c)   for a notification under subsection   (2)--specify the day the period of the shortage of the medicine in Australia ended; and

  (d)   contain any other information required by that form.

  (4)   An approval of a form may require or permit information to be given in accordance with specified software requirements:

  (a)   on a specified kind of data processing device; or

  (b)   by way of a specified kind of electronic transmission.

Civil penalty

  (5)   A person contravenes this subsection if:

  (a)   the person is subject to a requirement under subsection   (1) or (2); and

  (b)   the person contravenes the requirement.

Maximum civil penalty:

  (a)   for an individual--100 penalty units; and

  (b)   for a body corporate--1,000 penalty units.