Veterinary Drug Evaluation Fees Regulations
SOR/96-143
Registration 1996-03-12
Regulations Prescribing the Fees to be Paid for a Veterinary Drug Submission Evaluation Service Provided by or on Behalf of Her Majesty in Right of Canada
P.C. 1996-295 1996-03-12
His Excellency the Governor General in Council, on the recommendation of the Minister of National Health and Welfare and the Treasury Board, pursuant to paragraph 19(1)(a)Footnote * of the Financial Administration Act, is pleased hereby to make the annexed Regulations prescribing the fees to be paid for a veterinary drug submission evaluation service provided by or on behalf of Her Majesty in right of Canada.
Return to footnote *S.C. 1991, c. 24, s. 6
Short Title
1 These Regulations may be cited as the Veterinary Drug Evaluation Fees Regulations.
Interpretation
2 All words and expressions used in these Regulations have the meanings assigned to them by the Food and Drugs Act or the Food and Drug Regulations.
Application
3 These Regulations apply only in respect of drugs for veterinary use.
4 These Regulations do not apply in respect of a drug for veterinary use for which a submission, supplement or application referred to in any of sections 5 to 11 was filed on or before March 31, 1995.
New Drug Submission
5 Every person who includes, in a new drug submission referred to in section C.08.002 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule I shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Supplement to a New Drug Submission
6 Every person who includes, in a supplement to a new drug submission referred to in section C.08.003 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule II shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission
7 Every person who includes, in an abbreviated new drug submission or a supplement to an abbreviated new drug submission referred to in section C.08.002 or C.08.003 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule III shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Drug Identification Number (Din)
8 Every person who includes, in an application for a drug identification number referred to in section C.01.014.1 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule IV shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Preclinical New Drug Submission
9 Every person who includes, in a preclinical new drug submission referred to in section C.08.005 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule V shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Experimental Studies Certificate
10 Every person who includes, in an application for an experimental studies certificate referred to in section C.08.014 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule VI shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Emergency Drug Sale
11 Every person who includes, in an application for a letter of authorization referred to in section C.08.010 of the Food and Drug Regulations, one or more components set out in column I of an item of Schedule VII shall pay the applicable fee set out in column II of that item for the screening and examination of each component.
Submission, Supplement or Application Filed on or After April 1, 1996
12 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 that is filed on or after April 1, 1996.
(2) Where the sum of the fees for components included in a submission, supplement or application is $10,000 or less, the fee for each component is payable at the time that the submission, supplement or application is filed.
(3) Where the sum of the fees for components included in a submission, supplement or application is more than $10,000, the fee for each component is payable as follows:
(a) 10% of the fee for the component at the time that the submission, supplement or application is filed;
(b) 40% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and
(c) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.
Submission, Supplement or Application Filed Before April 1, 1996
13 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 where
(a) it was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and
(b) as of April 1, 1996, the screening of the submission, supplement or application has not begun.
(2) Where the sum of the fees for components included in a submission, supplement or application is $10,000 or less, the fee for each component is payable on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened.
(3) Where the sum of the fees for components included in a submission, supplement or application is more than $10,000, the fee for each component is payable as follows:
(a) 10% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened;
(b) 40% of the fee for the component on receipt of a notice from the Minister or Director stating that the submission, supplement or application has been accepted for examination; and
(c) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.
14 (1) This section applies in respect of a submission, supplement or application referred to in any of sections 5 to 11 where
(a) it was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and
(b) as of April 1, 1996, the screening of the submission, supplement or application has begun but is not completed, or the submission, supplement or application has been screened and accepted for examination but one or more of the components included in it are not yet under examination.
(2) Notwithstanding sections 5 to 11, the fee payable for the examination of each component not yet under examination as of April 1, 1996 is 90% of the applicable fee set out in the relevant schedule.
(3) Where the sum of the fees for components that are included in a submission, supplement or application and that are not yet under examination is $10,000 or less, the fee for each such component is payable on the later of
(a) April 1, 1996, and
(b) the date of receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened and accepted for examination.
(4) Where the sum of the fees for components that are included in a submission, supplement or application and that are not yet under examination is more than $10,000, the fee for each such component is payable as follows:
(a) 50% of the fee for the component on the later of
(i) April 1, 1996, and
(ii) the date of receipt of a notice from the Minister or Director stating that the submission, supplement or application has been screened and accepted for examination; and
(b) 50% of the fee for the component on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.
15 (1) This section applies in respect of each component included in a submission, supplement or application referred to in any of sections 5 to 11 where
(a) the submission, supplement or application was filed during the period beginning on April 1, 1995 and ending on March 31, 1996; and
(b) as of April 1, 1996, the component is still under examination.
(2) Notwithstanding sections 5 to 11, the fee payable for the examination of each component that is included in a submission, supplement or application and that is still under examination is
(a) where 25% or more but less than 50% of the component remains to be examined, 15% of the applicable fee set out in the relevant schedule;
(b) where 50% or more but less than 75% of the component remains to be examined, 40% of the applicable fee set out in the relevant schedule; and
(c) where 75% or more of the component remains to be examined, 65% of the applicable fee set out in the relevant schedule.
(3) The fee for each component still under examination is payable as follows:
(a) 50% of that fee on receipt of a notice from the Minister or Director stating the percentage of the component that remains to be examined; and
(b) 50% of that fee on receipt of a notice from the Minister or Director stating that the examination of the component has been completed.
Reduction of Fees
16 (1) In this section, fee verification period, in respect of a drug for which an application is made under this section, means the period beginning on the date that the drug is first sold in Canada and ending three years after that date.
(2) A person who files a submission, supplement or application referred to in any of sections 5 to 7 may apply to the Minister or Director, as the case may be, for a reduction in the fee payable for each component included in the submission, supplement or application.
(3) The Minister or Director shall grant an application made under subsection (2) where
(a) the Minister or Director has reasonable grounds to believe that, during the fee verification period, the applicant’s revenue from sales in Canada of the drug to which the submission, supplement or application relates will be less than 10 times the sum of the applicable fees calculated in accordance with sections 5 to 7, 14 and 15; and
(b) the applicant submits with the application a fee for processing the application in the amount of $1,000.
(4) Notwithstanding sections 5 to 7, 14 and 15, where the Minister or Director grants an application made under subsection (2), the fee payable for the components included in the submission, supplement or application is the lesser of
(a) the sum of the applicable fees calculated in accordance with sections 5 to 7, 14 and 15, and
(b) the greater of
(i) 10% of the applicant’s anticipated revenue from sales of the drug in Canada during the fee verification period, and
(ii) 10% of the applicant’s actual revenue from sales of the drug in Canada during the fee verification period, as verified by audited sales records for the drug.
(5) The fee calculated in accordance with subsection (4) is payable as follows:
(a) 10% of the applicant’s anticipated revenue from sales of the drug in Canada during the fee verification period is payable at the times and in the manner set out in sections 12 to 15, as applicable; and
(b) the balance, if any, is payable 60 days after the day on which the fee verification period ends.
Coming into Force
17 These Regulations come into force on April 1, 1996.
SCHEDULE I(Section 5)
New Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 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 |
| 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 |
| 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 |
| 4 | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. | 31,470 |
| 5 | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration.Footnote for New Drug Submission1 | 2,900 |
| 6 | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength.Footnote for New Drug Submission2 | 480 |
| 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 |
| 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 |
| 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 |
| 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 |
| 11 | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.Footnote for New Drug Submission3 | 4,840 |
| 12 | Chemistry and manufacturing data to support one strength of a single dosage form. | 4,840 |
| 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 |
| 14 | Documentation to support a change of manufacturer.Footnote for New Drug Submission4 | 250 |
Return to footnote 1This is in addition to a route of administration referred to in item 1, 2 or 3.
Return to footnote 2One study to support strengths may be included with a new drug submission, under item 1, 2 or 3, without payment of the fee set out in item 6.
Return to footnote 3A medicinal ingredient that has been evaluated, within the last three years, in another submission to which reference is made is not required to be re-evaluated.
Return to footnote 4This item applies only where a new drug submission does not include any of the components set out in items 1 to 13.
SCHEDULE II(Section 6)
Supplement to aNew Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 1 | Efficacy data to support an additional indication in one animal species. | $12,590 |
| 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 |
| 3 | Efficacy and safety data (in the intended species) to support an indication in another animal species. | 15,980 |
| 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 |
| 5 | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. | 31,470 |
| 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 |
| 7 | Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration.Footnote for Supplement to aNew Drug Submission1 | 2,900 |
| 8 | Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength.Footnote for Supplement to aNew Drug Submission2 | 480 |
| 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 |
| 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 |
| 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 |
| 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 |
| 13 | Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process. | 4,840 |
| 14 | Chemistry and manufacturing data to support a change in formulation or dosage form. | 2,420 |
| 15 | Chemistry and manufacturing data to support a change in packaging or in the sterilization process. | 1,930 |
| 16 | Chemistry and manufacturing data to support an extension of the expiry dating. | 1,450 |
| 17 | Chemistry and manufacturing data to support the concurrent use of two drugs. | 1,450 |
| 18 | Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms. | 480 |
| 19 | Documentation to support a change to the name of a manufacturer or the brand name of a drug.Footnote for Supplement to aNew Drug Submission3 | 250 |
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.
SCHEDULE III(Section 7)
Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 1 | Any applicable component listed in Schedule II. | See Schedule II |
| 2 | Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form. | $2,900 |
| 3 | 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 |
| 4 | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug.Footnote for Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission1 | 4,840 |
| 5 | Chemistry and manufacturing data to support a single dosage form. | 4,840 |
| 6 | Documentation to support | 250 |
| (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.Footnote for Abbreviated New Drug Submission and Supplement to an Abbreviated New Drug Submission2 |
Return to footnote 1A medicinal ingredient that has been evaluated, within the last three years, in another submission to which reference is made is not required to be re-evaluated.
Return to footnote 2This item applies only where an abbreviated new drug submission or a supplement to an abbreviated new drug submission does not include any of the components set out in items 1 to 5.
SCHEDULE IV(Section 8)
Din Application
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 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 |
| 2 | Published references or other data. | 500 |
| 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.Footnote for Din Application11 | 250 |
Return to footnote 1This item applies only where a DIN application does not include either of the components set out in item 1 or 2.
SCHEDULE V(Section 9)
Preclinical New Drug Submission
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 7 | Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient.Footnote for Preclinical New Drug Submission11 | 4,840 |
| 8 | Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient. | 2,420 |
Return to footnote 1A medicinal ingredient that has been evaluated, within the last three years, in another submission to which reference is made is not required to be re-evaluated. In that case, the fee for item 8 would apply.
SCHEDULE VI(Section 10)
Experimental Studies Certificate
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 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 |
| 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 |
| 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 |
| 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 |
SCHEDULE VII(Section 11)
Emergency Drug Sale
| Column I | Column II | |
|---|---|---|
| Item | Component | Fee |
| 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 |
| 2 | Information and material to support the sale of a drug to be used in the emergency treatment of a food-producing animal. | 100 |
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