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Changing an OTC medicine: using the Changes Tables

Version 2.4, 4 December 2017

4 December 2017

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Change table: Packaging changes

Changes to the packaging for OTC medicines, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
Change codes Packaging changes Status codes Assurance codes Application level Applicable section of the Act
Container type (as defined in TGA Approved Terminology for Medicines) 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:

  1. Polystyrene to PVC, polyethylene, polypropylene or glass;
  2. PVC to polyethylene, polypropylene or glass;
  3. Polyethylene to glass or polypropylene of density ≥ 0.89;
  4. From one density of polyethylene to a higher density; or
  5. Any change between glass, polyethylene of density ≥ 0.95, and polypropylene of density ≥ 0.89.

N

See notifications guidance

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:

  1. PVC to PVC/PVDC or to PVC/PCTFE;
  2. PVC/PVDC to PVC/PCTFE;

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

See notifications guidance

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

See notifications guidance

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

  • Does not include any other changes to the labelling such as text, graphics, colour, font, etc.

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

See notifications guidance

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

See notifications guidance

5 CN 9D(2C)

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