Document ID: chunk:federal_register_of_legislation:C2024C00632:section:30ef:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 30EF (pt 1/2)
Character Range: 339996–342640

30EF  Reporting medicine shortages
 (1) A person in relation to whom a reportable medicine is included in the Register must notify the Secretary of any shortage of the medicine in Australia at a particular time. The person must do so:
 (a) for a shortage that has a critical impact at that time—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 shortage; 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 shortage.
Note: For reportable medicine, see section 30EH. For shortage of a medicine in Australia, see section 30EI.

Critical impact
 (2) The shortage of a medicine in Australia at a particular time has a critical impact if, at that time, the medicine is included in an instrument under section 30EJ.
 (3) The shortage of a medicine in Australia at a particular time also has a critical impact if:
 (a) either:
 (i) at that time, there are no registered goods that could reasonably be used as a substitute for the medicine; or
 (ii) at that time, there are other registered goods that could reasonably be used as a substitute for the medicine but the other registered goods are not likely to be available in sufficient quantities to meet the demand for the other registered goods that is likely to arise because of the shortage; and
 (b) the shortage has the potential to have a life‑threatening impact on, or a serious impact on the physical or mental health or functioning of, persons who take, or who may need to take, the medicine.

Notification requirements
 (4) A notification under subsection (1) must:
 (a) be in accordance with a form that is approved, in writing, by the Secretary; and
 (aa) specify the period of the shortage of the medicine in Australia; and
 (b) contain any other information required by that form.
Note: For period of a shortage of a medicine in Australia, see section 30EIA.
 (5) 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
 (6) A person contravenes this subsection if:
 (a) the person is subject to a requirement under subsection (1); 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.

Exceptions
 (7) Subsection (6) does not apply if:
 (a) paragraph (1)(a) and subsection (3) apply in relation to the