Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

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

Regulations are current to 2021-02-15 and last amended on 2020-04-01. Previous Versions

SCHEDULE 2(Section 21)

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

ItemColumn 1Column 2Column 3Column 4Column 5Column 6Column 7Column 8Column 9
Type of SubmissionComponentFee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)Fee ($)
Fiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal YearFiscal Year
2020-20212021-20222022-20232023-20242024-20252025-20262026-2027
1Application for drug identification numberInformation, 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 required9181,1481,4361,7141,9592,2042,448
2Application for drug identification numberPublished references or other data6387989981,1911,3611,5321,701
3Application for drug identification numberDocumentation 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 Only1320400500596681765850
4Notification — veterinary health productInformation contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product486486486486486486486
5New drug submissionEfficacy 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)20,37525,46931,83738,03343,46748,90054,333
6New drug submissionEfficacy 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 species12,34215,42819,28623,03926,33129,62232,913
7New drug submissionEfficacy 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 species29,63137,04046,30055,31263,21471,11679,017
8New drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,998
9New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,861
10New drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,632
11New drug submissionFor 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 species27,78334,72943,41251,86159,27066,67874,086
12New drug submissionFor 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 species37,04046,30057,87569,14079,01788,89398,770
13New drug submissionFor food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration3,6984,6235,7796,9037,8898,8769,861
14New drug submissionFor 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 species18,51323,14228,92834,55839,49544,43249,368
15New drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,456
16New drug submissionChemistry and manufacturing data to support one strength of a single dosage form6,1717,7159,64411,52013,16614,81116,456
17New drug submissionChemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 163,0863,8584,8235,7606,5847,4078,229
18New drug submissionDocumentation to support a change of manufacturerFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only2320400500596681765850
19Supplement to a new drug submissionEfficacy data to support an additional indication in one animal species16,05320,06725,08429,96534,24638,52742,807
20Supplement to a new drug submissionEfficacy 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 species12,34215,42819,28623,03926,33129,62232,913
21Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support an indication in another animal species20,37525,46931,83738,03343,46748,90054,333
22Supplement to a new drug submissionEfficacy 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 species29,63137,04046,30055,31263,21471,11679,017
23Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species40,12550,15762,69774,89985,59996,299106,998
24Supplement to a new drug submissionEfficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species9,86912,33615,42118,42221,05323,68526,316
25Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration3,6984,6235,7796,9037,8898,8769,861
26Supplement to a new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength6127659571,1431,3061,4691,632
27Supplement to a new drug submissionFor 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 species3,6984,6235,7796,9037,8898,8769,861
28Supplement to a new drug submissionFor 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 species18,51323,14228,92834,55839,49544,43249,368
29Supplement to a new drug submissionFor food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period9,25711,57114,46417,27919,74822,21624,684
30Supplement to a new drug submissionFor 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 required7,4099,26111,57613,82915,80417,78019,755
31Supplement to a new drug submissionChemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process6,1717,7159,64411,52013,16614,81116,456
32Supplement to a new drug submissionChemistry and manufacturing data to support a change in formulation or dosage form3,0863,8584,8235,7606,5847,4078,229
33Supplement to a new drug submissionChemistry and manufacturing data to support a change in the packaging or sterilization process2,4623,0783,8484,5955,2505,9066,562
34Supplement to a new drug submissionChemistry and manufacturing data to support an extension of the expiry date1,8502,3132,8913,4523,9454,4374,930
35Supplement to a new drug submissionChemistry and manufacturing data to support the concurrent use of two drugs1,8502,3132,8913,4523,9454,4374,930
36Supplement to a new drug submissionChemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form6127659571,1431,3061,4691,632
37Supplement to a new drug submissionDocumentation to support a change to the brand name of a drugFootnote for Fees for Examination of a Submission — Drugs for Veterinary Use Only3320400500596681765850
38Abbreviated new drug submission or supplement to an abbreviated new drug submissionComparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form3,6984,6235,7796,9037,8898,8769,861
39Abbreviated new drug submission or supplement to an abbreviated new drug submissionFor 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 product3,6984,6235,7796,9037,8898,8769,861
40Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data for a non-compendial medicinal ingredient of a drug6,1717,7159,64411,52013,16614,81116,456
41Abbreviated new drug submission or supplement to an abbreviated new drug submissionChemistry and manufacturing data to support a single dosage form6,1717,7159,64411,52013,16614,81116,456
42Abbreviated new drug submission or supplement to an abbreviated new drug submission

Documentation to support

320400500596681765850
43Preclinical submissionEfficacy 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 species6,1717,7159,64411,52013,16614,81116,456
44Preclinical submissionEfficacy 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 treated4,9356,1697,7129,21110,52711,84313,158
45Preclinical submissionFor 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 species18,51323,14228,92834,55839,49544,43249,368
46Preclinical submissionFor 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 species27,78334,72943,41251,86159,27066,67874,086
47Preclinical submissionFor 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 species37,04046,30057,87569,14079,01788,89398,770
48Preclinical submissionFor 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 species9,25711,57114,46417,27919,74822,21624,684
49Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient6,1717,7159,64411,52013,16614,81116,456
50Preclinical submissionChemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient3,0863,8584,8235,7606,5847,4078,229
51Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal51515151515151
52Sale of new drug for emergency treatmentInformation and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal102102102102102102102
53Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal980980980980980980980
54Experimental studies certificateInformation 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 animal490490490490490490490
55Experimental studies certificateInformation and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal2,9582,9582,9582,9582,9582,9582,958
56Experimental studies certificateInformation 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 animal490490490490490490490
57Notifiable changeInformation and material to support an application for a notifiable change1,6582,0732,5913,0953,5373,9784,420
58ProtocolA 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 certificate1,6582,0732,5913,0953,5373,9784,420
  • 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: