Document ID: chunk:federal_register_of_legislation:F2021L01325:clause:2_8
Version: federal_register_of_legislation:F2021L01325
Segment Type: clause
Provision Reference: sch 2 cl 8
Character Range: 5630–6821

8  General requirements
 (1) The information that is displayed on a label of a biological or HCT materials must be:
 (a) in English; and
 (b) clearly visible and not obscured; and
 (c) in legible and durable characters, with a letter height of not less than 1.5 millimetres; and
 (d) in metric units of measurement.
 (2) The label of a biological or HCT materials must:
 (a) be securely attached to the container and primary pack in which the biological or HCT materials are supplied; and
 (b) maintain integrity and remain attached to the container and primary pack at the relevant storage conditions for the biological and HCT materials.
 (3) The container of a biological or HCT materials must be labelled to ensure traceability to the donor of the HCT materials at each step of manufacture.
 (4) To avoid doubt, the requirements set out in this instrument do not apply in relation to transparent coverings, where those coverings enclose or wrap:
 (a) a container containing HCT materials; or
 (b) a container or primary pack containing a biological; and
the information required to be on or attached to the container or primary pack is clearly visible and not obscured by the covering.