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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 - active ingredients

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

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