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Change table: Formulation changes - excipient ingredients
Change codes | Formulation changes - excipient ingredients | Status codes | Assurance codes | Application level | Applicable section of the Act |
---|---|---|---|---|---|
ERT |
Removal of a fragrance, flavour, printing ink and/or colouring agent(s) if the total agent(s) are present at not more than 2% w/w or w/v (if grouping applies) Note: this change may result in consequential changes to labelling (including the PI/CMI) and/or specifications (e.g. deletion from the label of declared ingredients or change to visual identification) which should also be addressed in accordance with the 'Changes Table'. |
SAR | 1, 5, 13 | C1 | 23 |
GPI | Removal and/or addition of a fragrance, flavour, printing ink and/or colouring agent(s) (if grouping applies), other than change ERT | A | 1, 5, 13 | C2 | 23 |
Removal or addition of a fragrance, flavour, printing ink or colouring agent (if grouping doesn't apply) | NEW | ||||
GPR | The replacement of one proprietary ingredient with a different proprietary ingredient where the only difference between the two proprietary ingredients (other than name) is a change to the amount of an inactive component of the proprietary ingredient and/or manufacturing process (if grouping applies) other than ERT or GPI | A | 1, 5, 13 | C2 | 23 |
The replacement of one proprietary ingredient with a different proprietary ingredient other than GPI or GPR | NEW | ||||
Addition or deletion of an excipient other than those above in change GPI | NEW | ||||
GEX |
Amount of excipient (if grouping applies) provided the content of the excipient is not higher than previously approved for the dosage form - if unsure, contact OTC Medicines See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3 |
A | 1, 5, 13 | C2 | 23 |
GED |
Increase in the amount of an excipient (if grouping applies) where the content of the excipient is higher than previously approved for the dosage form - if unsure, contact OTC Medicines See also 'Batch to batch variations in quantities of certain excipients' ARGOM Appaendix 2, section 5.3 |
A | 1, 5, 13 | C3 | 23 |
Amount of excipient (if grouping doesn't apply) - see also 'Batch to batch variations in quantities of certain excipients' ARGOM Appendix 2, section 5.3 | NEW | ||||
EST | Type of starch (no change to quantity) |
N |
5, 12 | CN | 9D(2C) |