Fees for the examination of a submission: drugs for veterinary use only
| Item | Type of submission | Component | Fees as of April 1, 2023 | Fee as of April 1, 2024 |
|---|---|---|---|---|
| 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 | $1,891 | $2,257 |
| 2 | Application for drug identification number | Published references or other data | $1,314 | $1,569 |
| 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 drug | $658 | $786 |
| 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 | $538 | $562 |
| 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) | $41,917 | $50,015 |
| 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 | $25,392 | $30,298 |
| 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 |
$60,961 | $72,735 |
| 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 | $82,548 | $98,491 |
| 9 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | $7,610 | $9,079 |
| 10 | New drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | $1,261 | $1,505 |
| 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 | $57,158 | $68,199 |
| 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 | $76,201 | $90,918 |
| 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 | $7,610 | $9,079 |
| 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 | $38,088 | $45,446 |
| 15 | New drug submission | Chemistry and manufacturing data for a non compendial medicinal ingredient of a drug | $12,697 | $15,150 |
| 16 | New drug submission | Chemistry and manufacturing data to support one strength of a single dosage form | $12,697 | $15,150 |
| 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 | $6,350 | $7,578 |
| 18 | New drug submission | Documentation to support a change of manufacturer | $658 | $786 |
| 19 | Supplement to a new drug submission | Efficacy data to support an additional indication in one animal species | $33,026 | $39,406 |
| 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 | $25,392 | $30,298 |
| 21 | Supplement to a new drug submission | Efficacy and safety data (in the intended species) to support an indication in another animal species | $41,917 | $50,015 |
| 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 | $60,961 | $72,735 |
| 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 | $82,548 | $98,491 |
| 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 | $20,305 | $24,225 |
| 25 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration | $7,610 | $9,079 |
| 26 | Supplement to a new drug submission | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength | $1,261 | $1,505 |
| 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 | $7,610 | $9,079 |
| 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 | $38,088 | $45,446 |
| 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 | $19,045 | $22,724 |
| 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 | $15,243 | $18,187 |
| 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 | $12,697 | $15,150 |
| 32 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in formulation or dosage form | $6,350 | $7,578 |
| 33 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the packaging or sterilization process | $5,065 | $6,043 |
| 34 | Supplement to a new drug submission | Chemistry and manufacturing data to support an extension of the expiry date | $3,807 | $4,541 |
| 35 | Supplement to a new drug submission | Chemistry and manufacturing data to support the concurrent use of two drugs | $3,807 | $4,541 |
| 36 | Supplement to a new drug submission | Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form | $1,261 | $1,505 |
| 37 | Supplement to a new drug submission | Documentation to support a change to the brand name of a drug | $658 | $786 |
| 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 | $7,610 | $9,079 |
| 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 | $7,610 | $9,079 |
| 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 | $12,697 | $15,150 |
| 41 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Chemistry and manufacturing data to support a single dosage form | $12,697 | $15,150 |
| 42 | Abbreviated new drug submission or supplement to an abbreviated new drug submission | Documentation to support (a) a change of manufacturer, in the case of an abbreviated new drug submission; or (b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission | $658 | $786 |
| 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 | $12,697 | $15,150 |
| 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 | $10,153 | $12,114 |
| 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 | $38,088 | $45,446 |
| 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 | $57,158 | $68,199 |
| 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 | $76,201 | $90,918 |
| 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 | $19,045 | $22,724 |
| 49 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a non compendial medicinal ingredient | $12,697 | $15,150 |
| 50 | Preclinical submission | Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient | $6,350 | $7,578 |
| 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 | $57 | $60 |
| 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 | $114 | $120 |
| 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 | $1,082 | $1,130 |
| 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 | $542 | $566 |
| 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 | $3,262 | $3,406 |
| 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 | $542 | $566 |
| 57 | Notifiable change | Information and material to support an application for a notifiable change | $3,413 | $4,072 |
| 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 | $3,413 | $4,072 |
Please visit Fees for Veterinary Drugs for relevant guidance documents and forms.
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