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
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'.
1, 5, 13
Removal and/or addition of a fragrance, flavour, printing ink and/or colouring agent(s) (if grouping applies), other than change ERT
1, 5, 13
Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply)
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
1, 5, 13
The replacement of one proprietary ingredient with a different proprietary ingredient other than GPI or GPR
Addition or deletion of an excipient other than those above in change GPI
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
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.