Document ID: chunk:federal_register_of_legislation:F2021L00333:reg:7
Version: federal_register_of_legislation:F2021L00333
Segment Type: reg
Provision Reference: reg 7
Character Range: 5270–6675

7  General requirements

Requirements for medicines that are serialised
 (1) The requirements in relation to a medicine that is serialised, other than a medicine mentioned in subsection (2), are those requirements specified in:
 (a) section 8; and
 (b) section 9; and
 (c) section 10.
 (2) The requirements in relation to a medicine that is serialised without the application of a data matrix code, but which has a data matrix code containing a GTIN for a purpose other than serialisation, where the medicine satisfies the circumstance specified in subsection (3), are those requirements specified in:
 (a) section 9; and
 (b) section 10.
 (3) For subsection (2), the circumstance is that the medicine is dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person by a person mentioned in column 2 of item 1, 2, 3 or 4 in Schedule 8 to the Regulations.

Requirements for medicines that are not serialised
 (4) The requirements in relation to a medicine that is not serialised, but which has a data matrix code containing a GTIN applied to a unit of the medicine at a relevant level of packaging, are the requirements specified in:
 (a) section 9; and
 (b) section 10.
Note: The requirements in sections 9 and 10 only apply in relation to the units of the medicine that have a data matrix code containing a GTIN applied at a relevant level of packaging.