Document ID: chunk:federal_register_of_legislation:F2021L01325:clause:2_4
Version: federal_register_of_legislation:F2021L01325
Segment Type: clause
Provision Reference: sch 2 cl 4
Character Range: 1940–4242

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) batch;
(b) bioburden;
(c) biological;
(d) container;
(e) label;
(f) manufacture;
(g) primary pack;
(h) Register;
(i) standard.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
allogeneic use, in relation to a biological that comprises, contains or is derived from HCT materials, means administration to, or application in the treatment of, a person other than the person from whom the HCT materials used in the manufacture of the biological were collected.
autologous use, in relation to a biological that comprises, contains or is derived from HCT materials, means administration to, or application in the treatment of, the person from whom the HCT materials used in the manufacture of the biological were collected.
Class 1 biological has the same meaning as in the Regulations.
Class 2 biological has the same meaning as in the Regulations.
Class 3 biological has the same meaning as in the Regulations.
Class 4 biological has the same meaning as in the Regulations.
directed allogeneic use, in relation to a biological that comprises, contains or is derived from HCT materials, means allogeneic use for which all of the following paragraphs apply:
 (a) the HCT materials used in the manufacture of the biological are collected by, or under the professional supervision or direction of, a medical or dental practitioner; and
 (b) the biological is manufactured for administration to, or application in the treatment of, a designated patient who has a pre-existing condition by, or under the professional supervision or direction of, a medical or dental practitioner; and
 (c) the medical or dental practitioners mentioned in paragraphs (a) and (b) are registered in a State or internal Territory.
expiry date has the same meaning as in the Regulations.
HCT materials means one or more of the following materials:
 (a) human cells;
 (b) human tissues;
 (c) human stool;
that are collected for use in the manufacture of a biological and are:
 (d) materials intended to comprise, or be contained in, the biological; or
 (e) materials from which the biological is intended to be derived.
Regulations means the Therapeutic Goods Regulations 1990.