Document ID: chunk:federal_register_of_legislation:F2021L01325:clause:2_10
Version: federal_register_of_legislation:F2021L01325
Segment Type: clause
Provision Reference: sch 2 cl 10
Character Range: 7949–9756

10  Labels of biologicals
 (1) Subject to subsection (2), a biological must be labelled in accordance with the following:
 (a) all Part 1 information:
 (i) must be on or attached to the container and the primary pack of the biological; or
 (ii) where the biological is packaged in a sterile container— may instead be on or attached to the first external non-sterile layer of packaging and the primary pack of the biological; and
 (b) all Part 2 information must be:
 (i) on or attached to the container or the primary pack of the biological; or
 (ii) supplied with the container or the primary pack of the biological, including where the information is contained in an electronic reference document, with a link or QR code to the document on or attached to the container or the primary pack of the biological.
 (2) A biological exported from Australia must be labelled with information specified in item 1 of Part 1 of Schedule 2, that is on or attached:
 (a) to the container or the primary pack of the biological; or
 (b) where the biological is packaged in a sterile container—to the first external non-sterile layer of packaging and the primary pack of the biological.
 (3) In this section:
Part 1 information, in relation to a biological, means the information specified in an item of the table in Part 1 of Schedule 2 if:
 (a) the expression "in all cases" is mentioned in column 3 of that item; or
 (b) the circumstances mentioned in column 3 of that item exist in relation to the biological.
Part 2 information, in relation to a biological, means the information specified in an item of the table in Part 2 of Schedule 2 if:
 (a) the expression "in all cases" is mentioned in column 3 of that item; or
 (b) the circumstances mentioned in column 3 of that item exist in relation to the biological.