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  1. Veterinary Drug Evaluation Fees Regulations - SOR/96-143 (SCHEDULE VI)

    [...]

    Experimental Studies Certificate

    Column I Column II
    Item Component Fee
    1 Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal. $960
    2 Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal. 480
    3 Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal. 2,900
    4 Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal. 480

  2. Veterinary Drug Evaluation Fees Regulations - SOR/96-143 (SCHEDULE V)

    [...]

    Preclinical New Drug Submission

    Column I Column II
    Item Component Fee
    1 Efficacy 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
    2 Efficacy 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
    3 For 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
    4 For 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
    5 For 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
    6 For 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

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  3. Veterinary Drug Evaluation Fees Regulations - SOR/96-143 (SCHEDULE II)

    [...]

    Supplement to aNew Drug Submission

    Column I Column II
    Item Component Fee
    9 For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species. 2,900
    10 For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species. 14,520
    11 For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period. 7,260
    12 For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required. 5,810

    • [...]

    • Return to footnote 2One study to support strengths may be included with a supplement to a new drug submission, under item 1, 2 or 3, without payment of the fee set out in item 8.


  4. Veterinary Drug Evaluation Fees Regulations - SOR/96-143 (SCHEDULE I)

    [...]

    New Drug Submission

    Column I Column II
    Item Component Fee
    7 For 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
    8 For 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
    9 For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration. 2,900
    10 For 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

    • [...]

    • 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.


  5. Veterinary Drug Evaluation Fees Regulations - SOR/96-143

    Experimental Studies Certificate


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