Therapeutic Goods (Medicines and OTG—Authorised Supply) Rules 2022
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4 Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) health practitioner;
(b) listed goods;
(c) medicine;
(d) Register;
(e) registered goods;
(f) sponsor;
(g) supply;
(h) therapeutic goods.
In this instrument:
Act means the Therapeutic Goods Act 1989.
active ingredient has the same meaning as in the Regulations.
adverse event means the following:
(a) in relation to a medicine—an adverse event that occurs in relation to a person in Australia following the administration of a medicine;
(b) in relation to a therapeutic good that is not a medicine—an adverse event that occurs in relation to a person in Australia following the use of the therapeutic good that led, or might have led, to the death of, a serious injury to, or serious deterioration in the health of, that person.
Note: An adverse event may not necessarily have a causal relationship with the administration or use of the therapeutic good.
nurse practitioner means a person who is:
(a) registered under a law of a state or internal territory as a registered nurse; and
(b) endorsed as a nurse practitioner by the Nursing and Midwifery Board of Australia.
Note: The Nursing and Midwifery Board of Australia works in partnership with the Australian Health Practitioner Regulation Agency.
Regulations means the Therapeutic Goods Regulations 1990.
Therapeutic Goods Administration has the same meaning as in the Therapeutic Goods Regulations 1990.
therapeutic vaping kit has the same meaning as in the Regulations.
therapeutic vaping pack has the same meaning as in Regulations.
therapeutic vaping substance has the same meaning as in the Regulations.