Veterinary Drug Evaluation Fees Regulations (SOR/96-143)

Regulations are current to 2017-11-20

SCHEDULE III(Section 7)

ABBREVIATED NEW DRUG SUBMISSION AND SUPPLEMENT TO AN ABBREVIATED NEW DRUG SUBMISSION

Column IColumn II
ItemComponentFee
1Any applicable component listed in Schedule II.See Schedule II
2Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form.$2,900
3For 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
4Chemistry 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 14,840
5Chemistry and manufacturing data to support a single dosage form.4,840
6Documentation to support250
(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.

 
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