Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of subsection 18 (1) of the Act, all medicines, other than medicines of a class or kind listed in the 9th Schedule to the Poisons Standard, as in force from time to time, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).
(2) The exemption of a medicine is subject to the following conditions:
(a) the medicine is to be given to a person who satisfies the following criteria:
(i) the person is a Category A patient (as defined in subregulation (5)); and
(ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine being given to the person; and
(iii) the medical practitioner by whom, or at whose direction, the medicine is to be given to the person has signed a statement in relation to the person in the form approved by the Secretary for the purposes of this paragraph; and
(b) the medicine is dispensed on the prescription of a medical practitioner who has prescribed the medicine in accordance with good medical practice.
(3) A person who signs a statement referred to in subparagraph (2) (a) (iii) must send a copy of the statement to the Secretary within 4 weeks of signing it.
Penalty: 10 penalty units.
(3A) An offence under subregulation (3) is an offence of strict liability.
Note For strict liability , see section 6.1 of the Criminal Code .
(4) This regulation does not affect the operation of regulation 12.
(5) In this regulation:
"Category A patient" means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
"informed consent" , in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.