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  1. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (SCHEDULE 2)

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    Fees for Examination of a Submission — Drugs for Veterinary Use Only

    Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9
    Type of Submission Component Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($)
    Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
    2020-2021 2021-2022 2022-2023 2023-2024 2024-2025 2025-2026 2026-2027
    11 New drug submission 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 27,783 34,729 43,412 51,861 59,270 66,678 74,086
    12 New drug submission 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 37,040 46,300 57,875 69,140 79,017 88,893 98,770
    13 New drug submission For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    14 New drug submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    27 Supplement to a new drug submission 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 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    28 Supplement to a new drug submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    29 Supplement to a new drug submission For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period 9,257 11,571 14,464 17,279 19,748 22,216 24,684
    30 Supplement to a new drug submission 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 7,409 9,261 11,576 13,829 15,804 17,780 19,755
    39 Abbreviated new drug submission or supplement to an abbreviated new drug submission For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    43 Preclinical submission 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 6,171 7,715 9,644 11,520 13,166 14,811 16,456
    44 Preclinical submission 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 4,935 6,169 7,712 9,211 10,527 11,843 13,158
    45 Preclinical submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    46 Preclinical submission 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 27,783 34,729 43,412 51,861 59,270 66,678 74,086
    47 Preclinical submission 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 37,040 46,300 57,875 69,140 79,017 88,893 98,770
    48 Preclinical submission 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 9,257 11,571 14,464 17,279 19,748 22,216 24,684
    53 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal 980 980 980 980 980 980 980
    54 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal 490 490 490 490 490 490 490
    55 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal 2,958 2,958 2,958 2,958 2,958 2,958 2,958
    56 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal 490 490 490 490 490 490 490
    58 Protocol A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate 1,658 2,073 2,591 3,095 3,537 3,978 4,420

    [...]


  2. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (SCHEDULE 2)

    [...]

    [...]

    Fees for Examination of a Submission — Drugs for Veterinary Use Only

    Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9
    Type of Submission Component Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($) Fee ($)
    Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year
    2020-2021 2021-2022 2022-2023 2023-2024 2024-2025 2025-2026 2026-2027
    11 New drug submission 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 27,783 34,729 43,412 51,861 59,270 66,678 74,086
    12 New drug submission 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 37,040 46,300 57,875 69,140 79,017 88,893 98,770
    13 New drug submission For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    14 New drug submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    27 Supplement to a new drug submission 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 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    28 Supplement to a new drug submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    29 Supplement to a new drug submission For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period 9,257 11,571 14,464 17,279 19,748 22,216 24,684
    30 Supplement to a new drug submission 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 7,409 9,261 11,576 13,829 15,804 17,780 19,755
    39 Abbreviated new drug submission or supplement to an abbreviated new drug submission For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product 3,698 4,623 5,779 6,903 7,889 8,876 9,861
    43 Preclinical submission 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 6,171 7,715 9,644 11,520 13,166 14,811 16,456
    44 Preclinical submission 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 4,935 6,169 7,712 9,211 10,527 11,843 13,158
    45 Preclinical submission 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 18,513 23,142 28,928 34,558 39,495 44,432 49,368
    46 Preclinical submission 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 27,783 34,729 43,412 51,861 59,270 66,678 74,086
    47 Preclinical submission 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 37,040 46,300 57,875 69,140 79,017 88,893 98,770
    48 Preclinical submission 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 9,257 11,571 14,464 17,279 19,748 22,216 24,684
    53 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal 980 980 980 980 980 980 980
    54 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal 490 490 490 490 490 490 490
    55 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal 2,958 2,958 2,958 2,958 2,958 2,958 2,958
    56 Experimental studies certificate Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal 490 490 490 490 490 490 490
    58 Protocol A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate 1,658 2,073 2,591 3,095 3,537 3,978 4,420

    [...]


  3. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (SCHEDULE 1)

    [...]

    Fees for Examination of a Submission — Drugs for Human Use

    Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6
    Submission Class Description Fee ($) Fee ($) Fee ($) Fee ($)
    Fiscal Year Fiscal Year Fiscal Year Fiscal Year
    2020-2021 2021-2022 2022-2023 2023-2024
    4 Comparative studies Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance 53,836 55,848 57,859 59,870

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  4. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (SCHEDULE 1)

    [...]

    [...]

    Fees for Examination of a Submission — Drugs for Human Use

    Item Column 1 Column 2 Column 3 Column 4 Column 5 Column 6
    Submission Class Description Fee ($) Fee ($) Fee ($) Fee ($)
    Fiscal Year Fiscal Year Fiscal Year Fiscal Year
    2020-2021 2021-2022 2022-2023 2023-2024
    4 Comparative studies Submissions based on comparative studies (e.g., clinical or non-clinical data, bioavailability data and data on the pharmacokinetics and pharmacodynamics of the drug) with or without chemistry and manufacturing data for a drug that does not include a new active substance 53,836 55,848 57,859 59,870

  5. Fees in Respect of Drugs and Medical Devices Order - SOR/2019-124 (Section 2)
    Marginal note:Purpose — fees

    • 2 (1) The purpose of this Order is to fix the fees for the following:

      • [...]

      • (b) in respect of drugs for veterinary use only, the examination of a notification for a veterinary health product filed under subsection C.01.615(1) of the Food and Drug Regulations, a preclinical submission filed under subsection C.08.005(1) of those Regulations, information filed under section C.08.010 of those Regulations for the purpose of obtaining a letter of authorization, information and material filed under section C.08.014 of those Regulations for the purpose of obtaining an experimental studies certificate, information and material filed with the Minister in respect of a notifiable change or a protocol filed with the Minister;

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