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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: Formulation changes - excipient ingredients

Changes to the formulation of excipient ingredients, 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 Formulation changes - excipient ingredients Status codes Assurance codes Application level Applicable section of the Act
ERT

Removal of a fragrance, flavour, printing ink and/or colouring agent(s) if the total agent(s) are present at not more than 2% w/w or w/v (if grouping applies)

Note: this change may result in consequential changes to labelling (including the PI/CMI) and/or specifications (e.g. deletion from the label of declared ingredients or change to visual identification) which should also be addressed in accordance with the 'Changes Table'.

SAR 1, 5, 13 C1 23
GPI Removal and/or addition of a fragrance, flavour, printing ink and/or colouring agent(s) (if grouping applies), other than change ERT A 1, 5, 13 C2 23
Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply) NEW
GPR The replacement of one proprietary ingredient with a different proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is a change to the amount of an inactive component of the proprietary ingredient and/or manufacturing process (if grouping applies) other than ERT or GPI A 1, 5, 13 C2 23
The replacement of one proprietary ingredient with a different proprietary ingredient other than GPI or GPR NEW
Addition or deletion of an excipient other than those above in change GPI NEW
GEX

Amount of excipient (if grouping applies) provided the content of the excipient is not higher than previously approved for the dosage form - if unsure, contact OTC Medicines

See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3

A 1, 5, 13 C2 23
GED

Increase in the amount of an excipient (if grouping applies) where the content of the excipient is higher than previously approved for the dosage form - if unsure, contact OTC Medicines

See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appaendix 2, section 5.3

A 1, 5, 13 C3 23
Amount of excipient (if grouping doesn't apply) - see also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3 NEW
EST Type of starch (no change to quantity)

N

See notifications guidance

5, 12 CN 9D(2C)

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