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Guidance on product changes in ELF3

31 August 2012

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Changes table: Active ingredient formulation changes

Product details Type of change Fee payable
1. Animal content in a product
Change or update addition to animal part, animal preparation or animal type. ARTG No
Change or update to the country of origin for an ingredient of animal origin. ARTG No
Change or update deletion to the Pre-clearance Number for an ingredient of animal origin. ARTG No
Change to the 'Is this ingredient of human or animal origin' field when the ingredient type is an AAN. ARTG No
2. Carrier details
Change to the carrier quantity or carrier unit when the carrier is restricted. Group Yes
Change, addition or deletion of a carrier when the ingredient type is an AHN. New Yes
Change to the quantity of a non restricted carrier. Vary Yes
3. Component details
Update addition of a restricted component. ARTG No
Update addition to the field 'component standardised on this ingredient'. ARTG No
Update addition to the quantity or unit of a restricted component. ARTG No
Update addition to the quantity or quantity unit of a non-restricted mandatory component. ARTG No
Update addition of a mandatory unrestricted component. ARTG No
Change, addition or deletion to a standardised component of an active ingredient when the ingredient type is an AHN. ARTG No
Change to the quantity or units of a standardised component when the ingredient type is an AHN. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has changed. New Yes
Change to the equivalent quantity or unit when the ingredient is AHN and the component is not standardised. New Yes
Change to the ingredient quantity or units when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has changed. New Yes
Change to the component when the component is restricted. ARTG No
Change to the quantity or unit of a restricted component. New Yes
Change to the final preparation ratio amount or type when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has not changed. New Yes
Change to the ingredient quantity or unit when the ingredient type is an AHN, the component is not standardised and the equivalent preparation quantity has not changed. New Yes
Change to the 'component standardised on this ingredient' field when the ingredient type is an AHN. Vary Yes
Change to the quantity of an unrestricted mandatory component. Vary Yes
Change to a mandatory unrestricted and non-standardised component. Vary Yes
Change, update addition or update deletion to the component quantity or component unit when the component is unrestricted, non-mandatory and non-standardised. Vary Yes
Change to the equivalent quantity or unit when the ingredient type is AHN and a component is standardised and the standardised component quantity has not changed. Vary Yes
Change to the ingredient quantity or unit when the ingredient type is AHN and a component is standardised and the standardised component quantity has not changed. Vary Yes
4. Equivalent preparation, equivalent quantity or equivalent unit details
Update addition or update deletion to the equivalent preparation when the ingredient type is an AHN. ARTG No
Update addition to the equivalent preparation when the ingredient type is an AHN and the equivalent is restricted. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit when the ingredient type is an AHS. ARTG No
Change to the equivalent preparation, equivalent quantity or equivalent unit when the ingredient type is an AHS. Vary Yes
5. Homoeopathic product
Addition to the potency of an active homoeopathic ingredient ARTG No
Update addition to the ingredient quantity or ingredient unit when the ingredient role is active homoeopathic. ARTG No
Addition to the diluent quantity or unit of an active homoeopathic ingredient when the diluent is not restricted. ARTG No
Update addition in the 'Label name' field of an active homoeopathic. ARTG No
Addition to the percentage of diluent of an active homoeopathic ingredient. ARTG No
Addition to the diluent quantity or diluent unit when the diluent is restricted and the ingredient role is active homoeopathic. ARTG No
Update addition or update deletion to the equivalent preparation, equivalent quantity or equivalent unit of an active homoeopathic when the ingredient type is an AHN or an AHS. ARTG No
Update addition or update deletion in the field 'Diluent Not Present' when the role is active homoeopathic. ARTG No
Change to the percentage of diluent of an active homoeopathic ingredient. Group Yes
Change to the diluent quantity or diluent unit when the diluent is restricted and the ingredient role is active homoeopathic. Group Yes
Change to the potency of an active homoeopathic ingredient. New Yes
Change to the diluent quantity or unit of an active homoeopathic ingredient when the diluent is not restricted. Vary Yes
Change in the 'Label name' field of an active homoeopathic. Vary Yes
Change to the equivalent preparation, equivalent quantity or equivalent unit of an active homoeopathic when the ingredient type is AHN or AHS. Vary Yes
6. Ingredient type - AAN, ABN, AHN, AHS
Update addition to the ingredient quantity or ingredient unit when the ingredient type is AAN, ABN, AHN or AHS. ARTG No
Change, addition or deletion of an active ingredient. New Yes
Change in the quantity or concentration of an active ingredient. New Yes
Change to the final preparation ratio type when the ingredient type is AHN. New Yes
Change to the equivalent quantity or unit when the ingredient type is AHN and the standardised component quantity has changed. New Yes
Change to the equivalent preparation when the ingredient type is AHN. New Yes
Change to the ingredient quantity or units when the ingredient type is AHN and the component is standardised and the standardised component quantity has changed. New Yes
Change to the final preparation ratio amount when the ingredient type is AHN. New Yes
7. Plant part or preparation of an ingredient that is an AHN
Addition to plant part or preparation when the ingredient type is an AHN. ARTG No
Change to plant part or preparation when the ingredient type is an AHN. New Yes
8. Solvent
Addition of a solvent when the ingredient type is an AHN. ARTG No
Addition of the percentage of solvent when 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
Update addition of solvent residue when the solvent is restricted and the ingredient type is an AHN. ARTG No
Update addition or update deletion to the solvent residue quantity or solvent residue unit when the solvent is unrestricted and the ingredient type is an AHN. ARTG No
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 of a solvent when the ingredient type is an AHN. New Yes
Change to the percentage of solvent when the ingredient type is an AHN. New Yes
Change, addition or deletion of residual solvent when the solvent is not restricted and the ingredient is an AHN. Vary Yes
Change to the solvent residue quantity or solvent residue unit when the solvent is not restricted and the ingredient type is an AHN. Vary Yes
9. Step in preparation
Addition of a step in preparation when the ingredient type is an AHN. 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 preparation when the ingredient type is an AHN. New Yes
Change to the preparation step ratio or preparation step ratio type when the ingredient type is an AHN. Vary Yes

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