4Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) export only medicine;
(b) manufacture;
(c) medicine;
(d) Register;
(e) standard;
(f) supply;
(g) therapeutic goods.

In this instrument:

Act means the Therapeutic Goods Act 1989.

allogeneic use, in relation to an HCT product, 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 product were collected.

asystole, in relation to a donor of HCT materials, means the reference time for cardiac death, being:

(a) the documented pronounced time of death; or
(b) if death is not witnessed—the last time the donor was known to be alive; or
(c) if the donor of the HCT materials is also a solid organ donor—the cross-clamp time.

autologous use, in relation to an HCT product, means administration to, or application in the treatment of, the person from whom the HCT materials used in the manufacture of the product were collected.

blood means whole blood collected from a single human donor and that is:

(a) used for infectious disease testing; or
(b) processed either for transfusion or further manufacturing.

blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:

(a) plasma;
(b) platelets;
(c) red cells;
(d) white cells;

but does not include haematopoietic progenitor cells.

directed allogeneic use, in relation to an HCT product, means allogeneic use for which all of the following paragraphs apply:

(a) the HCT materials used in the manufacture of the product are collected by, or under the professional supervision or direction of, a medical or dental practitioner; and
(b) the product 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.