Change table: Formulation changes - active ingredients

Version 2.4, 4 December 2017

Last updated

4 December 2017

Changes to the formulation of the active ingredient, 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 - active ingredients	Status codes	Assurance codes	Application level	Applicable section of the Act
	Addition of active ingredient	NEW
	Deletion of active ingredient	NEW
	Amount of an active ingredient - see also 'Overages and ranges' in ARGOM Appendix 2, section 4.1	NEW
AOV	Overage - decrease or removal	N See guidance	5	CN	9D(2C)
AOA	Overage - increase	A	5	C2	9D(3)
GPA	Replacement of a proprietary ingredient which contains an active substance with another proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is to the amount of an excipient(s) ingredient (if grouping applies)	A	1, 5	C2	23
	Replacement of a proprietary ingredient which contains an active ingredient with another proprietary ingredient, other than as above in change GPA	NEW