30EFReporting medicine shortages

#### 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 shortage but subsection (2) does not; and (b) as a result of steps taken by the person, it was reasonable for the person to assume that paragraph (1)(b) applied in relation to the shortage; and (c) the person complied with paragraph (1)(b) in relation to the shortage. (8) A person is not subject to a requirement under subsection (1), in relation to a shortage (the relevant shortage) of a medicine in Australia at a particular time, if: (a) the person has complied with the requirement under subsection (1) in relation to a shortage (the notified shortage) of the same medicine at an earlier time; and (b) the period of the shortage of the medicine in respect of the notified shortage (including any change to that period) is the same as the period of the shortage of the medicine in respect of the relevant shortage. > Note: Example: There is a shortage of a medicine in Australia on 1 January 2024 because, at a time in the 6 months after that day, the supply of the medicine in Australia will not meet demand for the medicine (see section 30EI). The period of the shortage of the medicine will start on 1 March 2024 and end on 31 March 2024 (see section 30EIA). > Note: The person in relation to whom the medicine is included in the Register has notified the Secretary of the shortage under this section. > Note: On 1 February 2024 the period of the shortage of the medicine changes to a period that will start on 1 May 2024 and end on 31 May 2024. > Note: The person must notify the change to the period of the shortage (see subsection 30EFA(1)). The person is not required to notify, under this section, of another shortage of the same medicine in respect of that same period starting on 1 May 2024 and ending on 31 May 2024.