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Guidance on product changes in ELF3

31 August 2012

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Changes table: Product details change

Product details Type of change Fee payable
1. Code stock
Change to code stock container type. ARTG No
Update addition or update deletion to code stock type container closure, volume or unit or container type. ARTG No
Change to the code stock container closure, code stock container volume or code stock container volume unit. Vary Yes
2. Coded warning
Change, update addition, addition or deletion of coded warning. ARTG No
3. Confidentiality flags
Change to the confidentiality flags (e.g. 'Can this product be used as a code stock, Will excipient ingredients be confidential from agents') ARTG No
4. Container
Change, update addition or update deletion to container type. ARTG No
Change, update addition or update deletion to the type of container closure, volume or volume unit. ARTG No
Change to the type of container closure, volume, volume unit. Vary Yes
5. Daily dose
Update addition or update deletion to the quantity or unit of the maximum recommended daily dose (MRD) when the formulation does not contain an ingredient restricted by MRD. ARTG No
Update addition to the MRD quantity or unit when the formulation contains an ingredient restricted by MRD. ARTG No
Change to the MRD quantity or unit when the formulation contains an ingredient restricted by MRD. New Yes
Change to the quantity or unit of the MRD when the formulation does not contain an ingredient restricted by MRD. Vary Yes
Change to the MRD quantity or unit and change to the product name. New Yes
6. Dose - single recommended
Change to the maximum recommended single dose (MRS) quantity or unit when the formulation contains an ingredient restricted by MRS. New Yes
Change to the quantity or unit of MRS when the formulation does not contain an ingredient restricted by MRS. Vary Yes
Update addition or update deletion to the quantity or unit of the MRS when the formulation does not contain an ingredient restricted by MRS. ARTG No
Update addition to the MRS quantity or unit when the formulation contains an ingredient restricted by MRS. ARTG No
Change to the MRS quantity or unit and change to the product name. New Yes
7. Dosage form - including maximum and minimum weights
Update addition to the dosage form. ARTG No
Change to the dosage form. New Yes
Change or update addition to the minimum weight of divided dosage form quantity or unit when the formulation contains an ingredient restricted by concentration. ARTG No
Change, update addition or update deletion to the quantity or unit of the minimum weight of divided dosage form and the formulation does not contain an ingredient restricted by concentration. ARTG No
8. Formulation name
Update addition of Medicine formulation name. ARTG No
Addition or deletion of Medicine formulation name. New Yes
Change to Medicine formulation name. Vary Yes
9. Indications
Change, addition or deletion to indications. Group Yes
Change, addition or deletion to indications and change to product name. New Yes
10. Manufacturer details
Change of manufacturer location. ARTG No
Change, addition or deletion of manufacturer name. ARTG No
Change, addition or deletion of manufacturer steps. ARTG No
Update addition of manufacturer location. ARTG No
11. Medicine kit
Change, addition or deletion of a medicine from a Medicine kit. New Yes
12. Product type and name
Change to the product type. ARTG No
Update addition to the product type. ARTG No
Change to product name. Group Yes
Change, addition or deletion to product export names. Group Yes
Change to product name and change, addition or deletion to indications. New Yes
Change to product name and change to the MRD quantity or unit or change to the MRS quantity or unit. New Yes
13. Route of administration
Change, addition or deletion to the route of administration. Vary Yes

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