Therapeutic Goods (Charges) Regulations 2018
5Definitions
Start here
Get a plain-English read of 5
Turn the raw legal text into a practical explanation grounded in Therapeutic Goods (Charges) Regulations 2018.
5 Definitions
Note: Subsection 3(1) of the Act incorporates the Therapeutic Goods Act 1989. A number of expressions used in this instrument are defined in the Therapeutic Goods Act 1989, including the following:
(a) biological (see also section 6 for classes of biological, but see the note to the definition of biologic);
(b) current Poisons Standard;
(c) grouped therapeutic goods;
(d) medical device (see also section 6 for classes of medical device);
(e) medicine;
(f) Register;
(g) registered goods;
(h) therapeutic goods.
In this instrument:
Act means the Therapeutic Goods (Charges) Act 1989.
biologic means therapeutic goods in which the active ingredient is a substance of biological origin (within the ordinary meaning of the term “biological”) that:
(a) in many cases, is chemically complex and with a molecular weight of more than 1,000; and
(b) is not defined by a chemical name because its purity, strength and exact composition cannot be readily determined by chemical analysis.
Note: Example: Hormones, enzymes and related substances are substances of biological origin of the type described. Herbal substances and antibiotics are not.
Note: The term “biological” is not used in this definition as defined in the Therapeutic Goods Act 1989.
charge year, in relation to an annual charge, means the financial year to which the charge relates.
haematopoietic progenitor cells has the same meaning as in Schedule 9 of the Therapeutic Goods Regulations 1990.
parent goods: see subsection 8(7).
relevant goods: see subsection 8(5).