|Column I||Column II|
|1||Any applicable component listed in Schedule II.||See Schedule II|
|2||Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form.||$2,900|
|3||For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product.||2,900|
|4||Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.Footnote for ABBREVIATED NEW DRUG SUBMISSION AND SUPPLEMENT TO AN ABBREVIATED NEW DRUG SUBMISSION 1||4,840|
|5||Chemistry and manufacturing data to support a single dosage form.||4,840|
|6||Documentation to support||250|
|(a) a change of manufacturer, in the case of an abbreviated new drug submission; or|
|(b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission.Footnote for ABBREVIATED NEW DRUG SUBMISSION AND SUPPLEMENT TO AN ABBREVIATED NEW DRUG SUBMISSION 2|
Return to footnote 1A medicinal ingredient that has been evaluated, within the last three years, in another submission to which reference is made is not required to be re-evaluated.
Return to footnote 2This item applies only where an abbreviated new drug submission or a supplement to an abbreviated new drug submission does not include any of the components set out in items 1 to 5.
- Date modified: