Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) The Minister may, by legislative instrument:
(a) declare that there is a serious scarcity of specified medicine (the scarce medicine ) across the whole or a specified part or parts of Australia; and
(b) specify the medicine (the substitutable medicine ) that pharmacists are permitted to dispense in substitution for the scarce medicine and specify the circumstances in which that substitution is permitted.
Note 1: For specification by class, see subsection 13(3) of the Legislation Act 2003 .
Note 2: For variation and revocation, see subsection 33(3) of the Acts Interpretation Act 1901 .
Pre - conditions to making instrument
(2) The Minister may make an instrument under subsection (1) only if the Minister is satisfied:
(a) that either or both of the following apply:
(i) the supply of the scarce medicine in Australia is not currently meeting the demand for that medicine for all of the patients in Australia who take that medicine;
(ii) there is an imminent risk that supply of the scarce medicine in Australia will not, or will not be likely to, meet the demand for that medicine for all of the patients in Australia who take, or who may need to take, that medicine; and
(b) that there is a significant risk of adverse health consequences for patients in Australia if those patients are unable to take the scarce medicine; and
(c) of any other matters prescribed by the regulations for the purposes of this paragraph.
Kind of medicine that can be covered by instrument
(3) The scarce medicine, and the substitutable medicine, must be medicine:
(a) that contains one or more substances included in Schedule 4 to the current Poisons Standard; and
(b) that does not contain any substances included in Schedule 8 to that standard.
Suitability of substitutable medicine
(4) Without limiting paragraph (1)(b), the circumstances may relate to:
(a) the class of persons for whom the substitutable medicine is suitable; or
(b) the class of persons for whom the substitutable medicine is not suitable.
Period instrument in force
(5) Unless sooner revoked, an instrument under subsection (1) remains in force for the period specified in the instrument.
Note: For variation, see subsection 33(3) of the Acts Interpretation Act 1901 .