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) biological;
(b) container;
(c) health practitioner;
(d) manufacture;
(e) medicine;
(f) Register;
(g) standard:
(h) supply; and
(i) therapeutic goods.

In this instrument:

accepted donor has the meaning given by subsection 10(2).

Act means the Therapeutic Goods Act 1989.

allogeneic use, in relation to an FMT product, means administration to, or application in the treatment of, a person other than the person from whom the stool used in the manufacture of the FMT product was collected.

autologous use, in relation to an FMT product, means administration to, or application in the treatment of, the person from whom the stool used in the manufacture of the FMT product was 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) haematopoietic progenitor cells;
(b) plasma;
(c) platelets;
(d) red cells;
(e) white cells.

collection period, in relation to an accepted donor, means a period of 90 days or less over the course of which stool is collected from the accepted donor for use in the manufacture of FMT products, other than fresh FMT products.

critical materials means all the materials used in the collection of stool or the manufacture of FMT products that may directly affect the quality, safety or efficacy of the FMT products.

faecal microbiota transplant product has the same meaning as in the Regulations.

FMT products means therapeutic goods that are faecal microbiota transplant products.

fresh FMT products means FMT products that are:

(a) manufactured using stool that is processed in accordance with subsection 17(3); and
(b) administered to, or applied in the treatment of, a person in accordance with subsection 17(4).

haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells.

HBsAg means hepatitis B surface antigen.

HAV means hepatitis A virus.

HBV means hepatitis B virus.

HCV means hepatitis C virus.

HIV-1 means human immunodeficiency virus type 1.

HIV-2 means human immunodeficiency virus type 2.

HTLV-1 means human T-lymphotropic virus type 1.

HTLV-2 means human T-lymphotropic virus type 2.

in-house IVD medical device has the same meaning as in the MD Regulations.

IVD medical device has the same meaning as in the MD Regulations.

MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

proposed donor has the meaning given by subsection 10(1).

Regulations means the Therapeutic Goods Regulations 1990.

TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.

Note: TGO 108 is published on the Federal Register of Legislation at www.legislation.gov.au.

Therapeutic Goods Administration has the same meaning as in the Regulations.