Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021
6Application
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6 Application
This instrument applies to HCT products, other than: (a) a faecal microbiota transplant product; or (b) a sample of human cells or human tissues: (i) biopsied for in vitro diagnostic examination; and (ii) not for further manufacture, or reintroduction or transplant to a person; or (c) an HCT product for which all of the following subparagraphs apply: (i) the product is manufactured for autologous use only; and (ii) 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 (iii) the product is manufactured for administration to, or application in the treatment of, a patient by, or under the professional supervision or direction of, a medical or dental practitioner; and (iv) the practitioners mentioned in subparagraphs (ii) and (iii) are registered in a State or internal Territory.