Change codes | Packaging changes | Status codes | Assurance codes | Application level | Applicable section of the Act |
---|---|---|---|---|---|
Container type (as defined in Other terminology) | NEW | ||||
KBT | Container material - if the container is a bottle, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:
| N | 5, 13, 16 & 25 | CN | 9D(2C) |
KGL | Container material - clear to coloured glass | O | |||
KBL | Container material - if the container is a blister pack, the goods are a solid dosage form (e.g. tablet) and the change in material is of a type described below:
or the change to the plastic component is to a material with demonstrated lower or equivalent water permeability than the existing material (see for example USP monograph '<671> Containers Permeation'). | N | 5, 13 & 25 | CN | 9D(2C) |
KCI | Container - increase in container wall thickness | O | |||
KCT | Container - decrease in container wall thickness where the decrease in thickness is not considered to increase permeability of the container (e.g. a decrease in the wall thickness of a glass bottle) and where stability testing will continue for the full term of the products' shelf life and the TGA advised immediately of any batches not meeting specification. | O | |||
KCD | Container - decrease in container wall thickness, except where KBT, KBL or KCT apply | A | 5 | C2 | 9D(3) |
KOT | Container material-other than in changes KBT, KGL, KBL, KCI, KCD or KCT | A | 5 | C2 | 9D(3) |
KCL | Closure - other than changes in KCM or MDA | N | 5, 13 | CN | 9D(2C) |
KCM | Closure, where the closure also serves as a metering component (other than MDA) | A | 5 | C2 | 9D(3) |
MDA | Changes in pump or pump components of meter-dose aerosol (e.g. valve material) | A | 5 | C2 | 9D(3) |
KSL | Tamper evident seal - addition (including label notice to alert consumers to presence of seal). See also LAB | O | |||
KSX | Tamper evident seal - removal (including removal of label notice re seal). See also LAB | O | |||
KWA | Inert wadding material - addition, substitution or removal where stability is not affected by the action | O | |||
KDA | Desiccant - inclusion in container | A | 5 | C2 | 9D(3) |
KDX | Desiccant - removal from container | A | 5 | C2 | 9D(3) |
KPP | Specifications of primary pack except where the primary pack is also the container
Note: primary pack is defined in subsection 3(1) of the Act as "primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers" | O | |||
KSP | Introduction of a measuring device (e.g. spoon, cylinder) or applicator (e.g. finger cot). This change can include graphical representation (and associated wording where required) of the device on the label. A copy of current & proposed label must be supplied if the label is changed | SAR | 5, 24 | C1 | 9D(3) |
KMO | Removal of a measuring device where other means of accurately measuring the dose are readily available. This change can include the deletion of graphical representation of the device (including associated wording) on the label. Does not include changes to the directions for use or any other changes to labelling such as reformatting. A copy of current & proposed label must be supplied if the label is changed. | N | 5 | CN | 9D(2C) |
KMD | Changes to existing measuring device (e.g. spoon, cylinder) or applicator supplied with the goods or removal of an applicator, where other means of accurately administering the dose are readily available. This change can include changes to the graphical representation (and associated wording where required) of the device on the label. It can also include the addition or deletion of graphical representation (including associated wording) of the device on the label. A copy of current & proposed label must be supplied if the label is changed. | SAR | 5, 24 | C1 | 9D(3) |
KPA | Introduction of a primary pack (no new text or graphics) Note: primary pack is defined in subsection 3(1) of the Act as "primary pack, in relation to therapeutic goods, means the complete pack in which the goods, or the goods and their container, are to be supplied to consumers" | SAR | 5, 14 | C1 | 9D(3) |
KPX | Removal of a primary pack | SAR | 5, 17 | C1 | 9D(3) |
KRP | Introduction of a refill pack | A | 5 | C2 | 9D(3) |
KRR | Removal of refill pack | N | 5 | CN | 9D(2C) |
Change table: Packaging changes
Version 2.4, 4 December 2017
Last updated