Document ID: chunk:federal_register_of_legislation:F2021L01332:reg:6
Version: federal_register_of_legislation:F2021L01332
Segment Type: reg
Provision Reference: reg 6
Character Range: 10084–10584

6  Application
 (1) Subject to subsection (2), this instrument applies to biologicals.
 (2) This instrument does not apply to biologicals that are:
 (a) faecal microbiota transplant products; or
 (b) mentioned in item 13 of Schedule 5A to the Regulations, subject to compliance with the condition specified in that item; or
 (c) samples of HCT materials that are:
 (i) biopsied for in vitro diagnostic examination; and
 (ii) not for further manufacture, or reintroduction or transplant to a person.