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Guidance on product changes in ELF3

31 August 2012

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Changes table: Excipient ingredients formulation changes

Product details Type of change Fee payable
1. Animal content in a product
Change, addition or deletion to the Pre-clearance Number from an AAN or an ABN ingredient type of animal origin. ARTG No
Change or update addition to animal part, animal preparation or animal type. ARTG No
Change or update to the country of origin for animal part, animal preparation or animal type. ARTG No
Change to field 'Is this ingredient of human or animal origin' when the ingredient type is an AAN. Vary Yes
2. Carrier details
Change in the carrier quantity or carrier unit when the carrier is restricted and the ingredient type is an AHN. Group Yes
Change, addition or deletion of a carrier when the ingredient type is an AHN. New Yes
Change to the quantity of an unrestricted carrier. Vary Yes
3. Component details
Update addition of a restricted component. ARTG No
Update addition of a mandatory unrestricted component. ARTG No
Update addition to the component quantity or component unit when the component is restricted. ARTG No
Change to the component quantity or component unit when the component is restricted. Group Yes
Change, addition or deletion of an unrestricted non-mandatory component. Vary Yes
Change, addition or update deletion to the quantity or unit of an unrestricted non-mandatory component. Vary Yes
Change, update addition or update deletion to the quantity or unit of an unrestricted mandatory component. Vary Yes
4. Equivalent preparation, equivalent quantity or equivalent unit
Change to the equivalent preparation when the ingredient type is an AHN or an AFN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the equivalent preparation when the ingredient type is an AHN or an AFN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Update addition or update deletion to the equivalent preparation and the equivalent is not restricted and the ingredient type is an AHN or AFN. Vary Yes
Change to the equivalent quantity or equivalent unit when the equivalent is not restricted and the ingredient type is an AHN. Vary Yes
Change, addition or update deletion of equivalent quantity or equivalent unit when the equivalent is not restricted and the ingredient type is an AFN. Vary Yes
Change to the equivalent preparation, equivalent quantity or equivalent unit the ingredient type is an AHS. Vary Yes
Update addition to the equivalent preparation when the equivalent is restricted and the ingredient type is an AFN or an AHN. ARTG No
Update addition to the equivalent quantity or equivalent unit when the equivalent is restricted and the ingredient type is an AFN. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit the ingredient type is an AHS. ARTG No
Change to the equivalent quantity or equivalent unit when the equivalent is restricted and the ingredient type is an AHN or an AFN. Group Yes
5. Step in preparation or step ratio
Addition of a step in the preparation of an AHN when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. ARTG No
Addition of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. ARTG No
Addition to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. ARTG No
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. Vary Yes
Change or deletion of a step in the preparation of an AHN when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
6. Plant part or plant preparation
Addition to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is not as a colour fragrance, flavouring, or printing ink. ARTG No
Addition to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. ARTG No
Change to the plant preparation when the ingredient type is an AFN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the plant preparation when the ingredient type is an AFN and the ingredient purpose is not as a colour, flavouring, fragrance or printing ink. New Yes
Change to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the plant part or plant preparation when the ingredient type is an AHN and the ingredient purpose is not as a colour, flavouring, fragrance or printing ink. New Yes
Update addition of solvent when the ingredient type is an AHN. ARTG No
Update addition of residual solvent when the solvent is restricted and the ingredient type is an AHN. ARTG No
Update addition to the solvent percentage when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink and the ingredient type is an AHN. ARTG No
Update addition to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. ARTG No
Change or deletion of a solvent when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change or deletion of solvent details for ingredients that are not a colour, fragrance, flavouring, or printing ink. New Yes
Change to the solvent percentage when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the solvent residue quantity or solvent residue unit when the solvent is restricted and the ingredient type is an AHN. Group Yes
Change to the percentage of solvent when the ingredient type is an AHN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change, addition or deletion of residual solvent when the solvent is not restricted and the ingredient is an AHN. Vary Yes
8. Ingredient details
Change, addition or deletion of an excipient when the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change, addition or deletion of an excipient when the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change to the ingredient quantity or ingredient unit when the ingredient is restricted. Group Yes
Update addition to the ingredient quantity or ingredient unit when the ingredient is unrestricted. ARTG No
Change, addition or update deletion to the ingredient quantity or ingredient unit when the ingredient is unrestricted. ARTG No
9. Final preparation ratio
Change to the final preparation ratio amount or type when the ingredient type is an AHN and the ingredient purpose is only as a colour, fragrance, flavouring, or printing ink. Group Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN and the ingredient purpose is not as a colour, fragrance, flavouring, or printing ink. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN or an AFN. New Yes

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