Veterinary Drug Evaluation Fees Regulations (SOR/96-143)

Regulations are current to 2017-10-13

SCHEDULE II(Section 6)

SUPPLEMENT TO A NEW DRUG SUBMISSION

Column IColumn II
ItemComponentFee
1Efficacy data to support an additional indication in one animal species.$12,590
2Efficacy 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
3Efficacy and safety data (in the intended species) to support an indication in another animal species.15,980
4Efficacy 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
5Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species.31,470
6Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species.7,740
7Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration.Footnote for SUPPLEMENT TO A NEW DRUG SUBMISSION 12,900
8Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength.Footnote for SUPPLEMENT TO A NEW DRUG SUBMISSION 2480
9For 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
10For 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
11For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period.7,260
12For 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
13Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process.4,840
14Chemistry and manufacturing data to support a change in formulation or dosage form.2,420
15Chemistry and manufacturing data to support a change in packaging or in the sterilization process.1,930
16Chemistry and manufacturing data to support an extension of the expiry dating.1,450
17Chemistry and manufacturing data to support the concurrent use of two drugs.1,450
18Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms.480
19Documentation to support a change to the name of a manufacturer or the brand name of a drug.Footnote for SUPPLEMENT TO A NEW DRUG SUBMISSION 3250
  • Return to footnote 1This is in addition to a route of administration referred to in item 2 or 4.

  • Return to footnote 2One study to support strengths may be included with a supplement to a new drug submission, under item 1, 2 or 3, without payment of the fee set out in item 8.

  • Return to footnote 3This item applies only where a supplement to a new drug submission does not include any of the components set out in items 1 to 18.

 
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