Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsNote: 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.
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).