Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_6
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 6
Character Range: 7558–8486

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.