Fees in Respect of Drugs and Medical Devices Order (SOR/2019-124)
Full Document:
- HTMLFull Document: Fees in Respect of Drugs and Medical Devices Order (Accessibility Buttons available) |
- XMLFull Document: Fees in Respect of Drugs and Medical Devices Order [322 KB] |
- PDFFull Document: Fees in Respect of Drugs and Medical Devices Order [616 KB]
Regulations are current to 2024-10-14 and last amended on 2024-01-03. Previous Versions
SCHEDULE 2(Section 21)
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 | |||
1 | Application for drug identification number | Information, other than that referred to in item 2, to support an application for a drug identification number, including the submission of labelling material for a second review, if required | 918 | 1,148 | 1,436 | 1,714 | 1,959 | 2,204 | 2,448 |
2 | Application for drug identification number | Published references or other data | 638 | 798 | 998 | 1,191 | 1,361 | 1,532 | 1,701 |
3 | Application for drug identification number | Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only1 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
4 | Notification — veterinary health product | Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product | 486 | 486 | 486 | 486 | 486 | 486 | 486 |
5 | New drug submission | Efficacy 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) | 20,375 | 25,469 | 31,837 | 38,033 | 43,467 | 48,900 | 54,333 |
6 | New drug submission | Efficacy 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 | 12,342 | 15,428 | 19,286 | 23,039 | 26,331 | 29,622 | 32,913 |
7 | New drug submission | Efficacy 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 and dosage form and two indications in one animal species | 29,631 | 37,040 | 46,300 | 55,312 | 63,214 | 71,116 | 79,017 |
8 | New drug submission | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 40,125 | 50,157 | 62,697 | 74,899 | 85,599 | 96,299 | 106,998 |
9 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
10 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
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 |
15 | New drug submission | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
16 | New drug submission | Chemistry and manufacturing data to support one strength of a single dosage form | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
17 | New drug submission | Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 16 | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
18 | New drug submission | Documentation to support a change of manufacturerFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only2 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
19 | Supplement to a new drug submission | Efficacy data to support an additional indication in one animal species | 16,053 | 20,067 | 25,084 | 29,965 | 34,246 | 38,527 | 42,807 |
20 | Supplement to a new drug submission | Efficacy 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 | 12,342 | 15,428 | 19,286 | 23,039 | 26,331 | 29,622 | 32,913 |
21 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support an indication in another animal species | 20,375 | 25,469 | 31,837 | 38,033 | 43,467 | 48,900 | 54,333 |
22 | Supplement to a new drug submission | Efficacy 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 and dosage form and two indications in one animal species | 29,631 | 37,040 | 46,300 | 55,312 | 63,214 | 71,116 | 79,017 |
23 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species | 40,125 | 50,157 | 62,697 | 74,899 | 85,599 | 96,299 | 106,998 |
24 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species | 9,869 | 12,336 | 15,421 | 18,422 | 21,053 | 23,685 | 26,316 |
25 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
26 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
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 |
31 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
32 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in formulation or dosage form | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
33 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the packaging or sterilization process | 2,462 | 3,078 | 3,848 | 4,595 | 5,250 | 5,906 | 6,562 |
34 | Supplement to a new drug submission | Chemistry and manufacturing data to support an extension of the expiry date | 1,850 | 2,313 | 2,891 | 3,452 | 3,945 | 4,437 | 4,930 |
35 | Supplement to a new drug submission | Chemistry and manufacturing data to support the concurrent use of two drugs | 1,850 | 2,313 | 2,891 | 3,452 | 3,945 | 4,437 | 4,930 |
36 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form | 612 | 765 | 957 | 1,143 | 1,306 | 1,469 | 1,632 |
37 | Supplement to a new drug submission | Documentation to support a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only3 | 320 | 400 | 500 | 596 | 681 | 765 | 850 |
38 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form | 3,698 | 4,623 | 5,779 | 6,903 | 7,889 | 8,876 | 9,861 |
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 |
40 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
41 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Chemistry and manufacturing data to support a single dosage form | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
42 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Documentation to support
| 320 | 400 | 500 | 596 | 681 | 765 | 850 |
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 |
49 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient | 6,171 | 7,715 | 9,644 | 11,520 | 13,166 | 14,811 | 16,456 |
50 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | 3,086 | 3,858 | 4,823 | 5,760 | 6,584 | 7,407 | 8,229 |
51 | Sale of new drug for emergency treatment | Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal | 51 | 51 | 51 | 51 | 51 | 51 | 51 |
52 | Sale of new drug for emergency treatment | Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal | 102 | 102 | 102 | 102 | 102 | 102 | 102 |
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 |
57 | Notifiable change | Information and material to support an application for a notifiable change | 1,658 | 2,073 | 2,591 | 3,095 | 3,537 | 3,978 | 4,420 |
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 |
Return to footnote 1This item applies only to an application for a drug identification number that does not include either of the components set out in items 1 and 2.
Return to footnote 2This item applies only to a new drug submission that does not include any of the components set out in items 5 to 17.
Return to footnote 3This item applies only to a supplement to a new drug submission that does not include any of the components set out in items 19 to 36.
Return to footnote 4This item applies only to an abbreviated new drug submission or a supplement to an abbreviated new drug submission that does not include any of the components set out in items 38 to 41.
- Date modified: