Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:4:p2
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 4 (pt 2/2)
Character Range: 5825–8668

is published on the European Medicines Agency website at www.ema.europa.eu/en.
HCT materials means one or more of the following materials:
 (a) human cells;
 (b) human tissues;
that are collected for use in the manufacture of a biological and are:
 (c) materials intended to comprise, or be contained in, the biological; or
 (d) materials from which the biological is intended to be derived.
Note: Human cells and human tissues include human musculoskeletal tissue, human cardiovascular tissue, human ocular tissue, human skin, and human amnion.
human amnion product means a biological that comprises, contains or is derived from human amnion.
human cardiovascular tissue product means a biological that comprises, contains or is derived from human cardiovascular tissue, including aortic, pulmonary, mitral or tricuspid heart valves or any part of such valves, conduit or greater vessel graft, peripheral vascular tissue graft, or pericardial graft.
human ocular tissue product means a biological that comprises, contains or is derived from human ocular tissue, including the eye globe, cornea or sclera.
human musculoskeletal tissue product means a biological that comprises, contains or is derived from human musculoskeletal tissue, including bone, cartilage, fascia lata, ligament, muscle, and tendon.
human skin product means a biological that comprises, contains or is derived from human skin.
microorganism or microbe includes a bacterium, fungus, mycoplasma and rickettsia, but does not include a virus or prion.
Note: Other grammatical forms of the words microorganism and microbe have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901).
Example: Microbe and microbial have corresponding meanings.
minimal manipulation has the same meaning as in the Regulations.
processing, in relation to HCT materials, means any activity involved in the preparation, manipulation, preservation for storage and packaging of the materials.
Regulations means the Therapeutic Goods Regulations 1990.
skin means the outer integument or covering of the body, consisting of the dermis and the epidermis and resting on subcutaneous tissue.
specified microorganism means a microorganism of clinical significance that, if detected, necessitates rejection of HCT materials or a biological.
TGA Approach to TSE means the document titled Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure (Version 2.0, April 2014) published by the Therapeutic Goods Administration, as in force or existing from time to time.
Note: The TGA Approach to TSE is published on the Therapeutic Goods Administration website at www.tga.gov.au.
transportation means the transfer of a substance, material or product, within or between premises including manufacturing sites, under appropriate controlled conditions.