Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:4:p1
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 4 (pt 1/2)
Character Range: 3187–6077

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) bioburden;
(b) biological;
(c) container;
(d) manufacture;
(e) manufacturing site;
(f) standard;
(g) supply.
  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.
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 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.
critical materials means all the materials, other than HCT materials, used in the manufacture of a biological that may directly affect the quality, safety or efficacy of the biological.
cryopreservation, in relation to a biological, means suspension in a medium containing a suitable cryoprotectant and cooling according to a method that has been validated to allow maintenance for long periods.
Note: Other grammatical forms of the word cryopreservation (such as cryopreserved) have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901).
EBAANZ Standards for Eye Donation and Eye Tissue Banking means the document titled EBAANZ Medical and Quality Standards for Eye Donation and Eye Tissue Banking (Edition 2, April 2009) published by the Eye Bank Association of Australia and New Zealand (EBAANZ), as in force or existing at the commencement of this instrument.
Note: The document is published on the Eye Bank Association of Australia and New Zealand (EBAANZ) website at http://www.ebaanz.org/.
faecal microbiota transplant product has the same meaning as in the Regulations.
Guidance on Virus Validation Studies means the document titled Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses (February 1996) published by the European Medicines Agency, as in force or existing at the commencement of this instrument.
Note: The document 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)