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

Regulations are current to 2017-10-13

SCHEDULE I(Section 5)

NEW DRUG SUBMISSION

Column IColumn II
ItemComponentFee
1Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species. (In the case of an antiparasitic drug, several indications in one food animal species.)$15,980
2Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species.9,680
3Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration, dosage form and two indications in one animal species.23,240
4Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species.31,470
5Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration.Footnote for NEW DRUG SUBMISSION 12,900
6Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength.Footnote for NEW DRUG SUBMISSION 2480
7For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.21,790
8For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.29,050
9For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration.2,900
10For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species.14,520
11Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.Footnote for NEW DRUG SUBMISSION 34,840
12Chemistry and manufacturing data to support one strength of a single dosage form.4,840
13Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 12.2,420
14Documentation to support a change of manufacturer.Footnote for NEW DRUG SUBMISSION 4250
  • Return to footnote 1This is in addition to a route of administration referred to in item 1, 2 or 3.

  • Return to footnote 2One study to support strengths may be included with a new drug submission, under item 1, 2 or 3, without payment of the fee set out in item 6.

  • Return to footnote 3A 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 4This item applies only where a new drug submission does not include any of the components set out in items 1 to 13.

 
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