Change table: Formulation changes - excipient ingredients

Version 2.4, 4 December 2017

Last updated

4 December 2017

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)