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Guidance on product changes in ELF3

31 August 2012

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Changes table: Proprietary ingredients (PI) formulation changes

Product details Type of change Fee payable
Addition, deletion or change to ingredient name when the PI purpose is film coating or coating solutions. Group Yes
Change, addition or deletion to the PI name when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to PI quantity or ingredient unit when the ingredient is restricted and the PI is not an active pre-mix. Group Yes
Addition or deletion of PI name when the ingredient purpose is as a cream base, oral base, empty capsule shell, preservative pre-mix, excipient pre-mix or sweetener. New Yes
Update deletion to PI quantity or ingredient unit when the ingredient is not restricted and the PI is not an active pre-mix. ARTG No
Change, addition or deletion to the PI name when the purpose is active pre-mix. New Yes
Change, update addition or update deletion to PI quantity or ingredient unit when the ingredient is not restricted and the PI is not an active pre-mix. Vary Yes

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