Veterinary Drug Submission Evaluation Fees

Veterinary Drug Submission and Application Review Fees as of April 1, 2019
Item Fee Category Fees as of April 1, 2018 Fees as of April 1, 2019
New drug submission
1 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.) $15,980.00 $16,331.56
2 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. $9,680.00 $9,892.96
3 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, dosage form and two indications in one animal species. $23,240.00 $23,751.28
4 Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. $31,470.00 $32,162.34
5 Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration. $2,900.00 $2,963.80
6 Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength. $480.00 $490.56
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. $21,790.00 $22,269.38
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. $29,050.00 $29,689.10
9 For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration. $2,900.00 $2,963.80
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. $14,520.00 $14,839.44
11 Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. $4,840.00 $4,946.48
12 Chemistry and manufacturing data to support one strength of a single dosage form. $4,840.00 $4,946.48
13 Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 12. $2,420.00 $2,473.24
14 Documentation to support a change of manufacturer. $250.00 $255.50
Supplement to a new drug submission
1 Efficacy data to support an additional indication in one animal species. $12,590.00 $12,866.98
2 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. $9,680.00 $9,892.96
3 Efficacy and safety data (in the intended species) to support an indication in another animal species. $15,980.00 $16,331.56
4 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. $23,240.00 $23,751.28
5 Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. $31,470.00 $32,162.34
6 Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species. $7,740.00 $7,910.28
7 Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration. $2,900.00 $2,963.80
8 Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength. $480.00 $490.56
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. $2,900.00 $2,963.80
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. $14,520.00 $14,839.44
11 For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period. $7,260.00 $7,419.72
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. $5,810.00 $5,937.82
13 Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process. $4,840.00 $4,946.48
14 Chemistry and manufacturing data to support a change in formulation or dosage form. $2,420.00 $2,473.24
15 Chemistry and manufacturing data to support a change in packaging or in the sterilization process. $1,930.00 $1,972.46
16 Chemistry and manufacturing data to support an extension of the expiry dating. $1,450.00 $1,481.90
17 Chemistry and manufacturing data to support the concurrent use of two drugs. $1,450.00 $1,481.90
18 Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms. $480.00 $490.56
19 Documentation to support a change to the name of a manufacturer or the brand name of a drug. $250.00 $255.50
Abbreviated new drug submission and supplement to an abbreviated new drug submission
1 Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form. $2,900.00 $2,963.80
2 For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product. $2,900.00 $2,963.80
3 Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. $4,840.00 $4,946.48
4 Chemistry and manufacturing data to support a single dosage form. $4,840.00 $4,946.48
5 Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the name of a manufacturer or the brand name of a drug, in the case of a supplement to an abbreviated new drug submission. $250.00 $255.50
Drug identification number application
1 Information, other than that referred to in item 2, to support an application for a DIN, including the submission of labelling material for a second review, if required. $720.00 $735.84
2 Published references or other data. $500.00 $511.00
3 Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug. $250.00 $255.50
Preclinical New Drug Submission
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. $4,840.00 $4,946.48
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. $3,870.00 $3,955.14
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. $14,520.00 $14,839.44
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. $21,790.00 $22,269.38
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. $29,050.00 $29,689.10
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. $7,260.00 $7,419.72
7 Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient. $4,840.00 $4,946.48
8 Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient. $2,420.00 $2,473.24
Notifiable change or protocol review
1

Information and material to support an application for a Notifiable Change.

$1,300.00 $1,300.00
2 Request for the review of scientific information outside of a regular drug submission (i.e. review of a proposed trial protocol). $1,300.00 $1,300.00
Experimental studies certificate
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. $960.00 $981.12
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. $480.00 $490.56
3 Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal. $2,900.00 $2,963.80
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. $480.00 $490.56
Emergency drug sale
1 Information and material to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal. $50.00 $51.10
2 Information and material to support the sale of a drug to be used in the emergency treatment of a food-producing animal. $100.00 $102.20
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