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

Regulations are current to 2017-10-13

SCHEDULE V(Section 9)

PRECLINICAL NEW DRUG SUBMISSION

Column IColumn II
ItemComponentFee
1Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species.$4,840
2Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated.3,870
3For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species.14,520
4For 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
5For 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
6For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species.7,260
7Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient.Footnote for PRECLINICAL NEW DRUG SUBMISSION 114,840
8Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient.2,420
  • 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. In that case, the fee for item 8 would apply.

 
Date modified: