Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person in relation to whom a reportable medicine is included in the Register must notify the Secretary of any decision (the discontinuation decision ) of the person to permanently discontinue the supply of the medicine in Australia. The person must do so:
(a) if the discontinuation is likely to be of critical impact:
(i) at least 12 months before the discontinuation is proposed to occur; or
(ii) if the person is unable to comply with subparagraph (i)--as soon as practicable after the decision is made; or
(b) in any other case:
(i) at least 6 months before the discontinuation is proposed to occur; or
(ii) if the person is unable to comply with subparagraph (i)--as soon as practicable after the decision is made.
Note: For reportable medicine , see section 30EH.
Critical impact
(2) The discontinuation of the supply of a medicine in Australia is likely to be of critical impact if, when the discontinuation decision is made, the medicine is included in an instrument under section 30EJ.
(3) The discontinuation of the supply of a medicine in Australia is also likely to be of critical impact if:
(a) either:
(i) when the discontinuation decision is made, there are no registered goods that could reasonably be used as a substitute for the medicine; or
(ii) when the discontinuation decision is made, 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 discontinuation; and
(b) the discontinuation 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
(b) contain the information required by that form.
(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.
Exception
(7) Subsection (6) does not apply if:
(a) paragraph (1)(a) and subsection (3) apply in relation to the discontinuation 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 discontinuation; and
(c) the person complied with paragraph (1)(b) in relation to the discontinuation.