Veterinary Drug Submission Fee Application Form

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Table of Contents

Section 1: New Drug Submission

Section 2: Supplement to a New Drug Submission

Section 3: Abbreviated New Drug Submission or Supplement to an Abbreviated New Drug Submission

Section 4: DIN Application

Section 5: Preclinical (Investigational) New Drug Submission

Section 6: Notifiable Change or Protocol Review

Veterinary Drug Submission Fee Application Form

This form must be completed for every submission. In addition, please complete and submit only the section(s) which are necessary. One form may be used for multiple strengths of a single dosage form. However, individual Drug Submission Application Forms are still required to be submitted for each formulation strength.

• For a New Drug Submission complete Section 1.
  
  
• For a Supplement to a New Drug Submission complete Section 2.
  
  
• For an Abbreviated New Drug Submission or Supplement to an Abbreviated New Drug Submission complete Section 3.
  
  
• For a DIN Application complete Section 4.
  
  
• For a Preclinical (Investigational) New Drug Submission complete Section 5.
  
  
• For a Notifiable Change or Protocol Review complete Section 6.
  
  
• For an Experimental Studies Certificate Application complete an ESC Fee Application Form.
  
  
• For an Emergency Drug Release complete an EDR Application and Fee Form.

Is this an application for a phased submission review?

Yes   No

If this is an application for a fee reduction, please remit $1,000.

• Where the submission fee total is <$10,000, the full fee is due on filing.
  
  
• Where the submission fee total is >$10,000, 10% of the total fee is due on filing.

Identification

Product name:

Name of Manufacturer/Sponsor as per Drug Submission Application:

Address of Manufacturer/Sponsor:

Contact Person:

Telephone: Fax:

Billing address (if different):

Billing Contact Person:

Submission Information

Dosage Form:

Route(s) of Administration:

Strength(s) - A product with multiple strengths (eg. tablet) may be indicated:

Send completed form and remittance, made payable to "Receiver General for Canada", together with the submission to:

Submission and Knowledge Management Division
Veterinary Drugs Directorate
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue, Address Locator : 3000A
Ottawa, ON K1A 0K9

HPFB use only

Customer No.  S.O. No.

Submission No.  Invoice No.

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Product Name:

Submission No.:  

File No.:

Section 1: New Drug Submission

HC Protected

Component

Fee

x no.

Enter fee here

HPFB Use Only

1. Efficacy & safety data (intended species) for one route, dosage form & indication in 1 species. For antiparasitic, several indications in 1 food species.

$15,980

2. Efficacy & safety data (intended species) for one route & dosage form for an antiparasitic in 1 non-food species.

$9,680

3. Efficacy & safety data (intended species) for one route, dosage form & indication in 2 species; or one route, dosage form & 2 indications in 1 species.

$23,240

4. Efficacy & safety data (intended species) for a growth promotion or production enhancement indication in 1 species.

$31,470

5. Comparative (pharmacodynamic, clinical or bioavailability) data for additional route. (In addition to route referred to in item 1, 2 or 3.

$2,900

6. Comparative (Pharmacodynamic, clinical or bioavailability) data for each additional strength. (1 study to support strengths may be included with a NDS, under items 1, 2 or 3, without payment of this fee.)

$480

7. For food animals, toxicity, metabolism & residue depletion studies to establish an ADI with a SF of 1,000, a MRL & a withdrawal period for one dosage form, dosage & route in 1 species.

$21,790

8. For food animals, toxicity, metabolism & residue depletion studies to establish an ADI with a SF of <1,000, a MRL & a withdrawal period for one dosage form, dosage & route in 1 species.

$29,050

9. For food animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route.

$2,900

10. For food animals (once an ADI and a SF of # 1,000 has been established), metabolism & residue depletion studies to establish a MRL & a withdrawal period for one dosage form, dosage and route in an additional species.

$14,520

11. Chemistry & manufacturing for non-compendial medicinal ingredient. (A medicinal ingredient previously evaluated within the last 3 years, to which reference is made is not required to be reevaluated).

$4,840

12. Chemistry & manufacturing for one strength of 1 dosage form

$4,840

13. Chemistry & manufacturing for an additional strength of 1 dosage form submitted with item 12.

$2,420

14. Change in manufacturer of a drug. (Applies only where a NDS does not include any of the above components.)

$250

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature:   Date:

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Product Name:

Submission No.: File No.:

Section 2: Supplement to a New Drug Submission

HC Protected

Component

Fee

x no.

Enter fee here

HPFB Use Only

1. Efficacy data for an additional indication in 1 species.

$12,590

2. Efficacy & safety data (intended species) for one route & dosage form for an antiparasitic in 1 non-food species.

$9,680

3. Efficacy & safety data (intended species) for an indication in another species.

$15,980

4. Efficacy & safety data (intended species) for one route, dosage form & indication in 2 species; or one route, dosage form & 2 indications in 1 species.

$23,240

5. Efficacy & safety data (intended species) for a growth promotion or production enhancement indication in 1 species.

$31,470

6. Efficacy & safety data (intended species) for the concurrent use of 2 drugs approved for the same species.

$7,740

7. Comparative (pharmacodynamic, clinical or bioavailability) data for an additional route. (In addition to route referred to in item 2 or 4.)

$2,900

8. Comparative (pharmacodynamic, clinical or bioavailability) data for each additional strength. (1 study to support strengths may be included with a SNDS, under item 1, 2 or 3 without payment of this fee.)

$480

9. For food animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of an approved dosage form in 1 species.

$2,900

10. For food animals, metabolism & residue depletion studies to establish a MRL & a withdrawal period for one dosage & route of an approved dosage form in an additional species.

$14,520

11. For food animals, toxicity studies for a change of an established ADI, MRL & withdrawal period.

$7,260

12. For concurrent use of 2 drugs in a food species, residue depletion studies to determine if extension to withdrawal periods is required.

$5,810

13. Chemistry & manufacturing for change in source of noncompendial medicinal ingredient or its manufacturing process.

$4,840

14. Chemistry & manufacturing for change in formulation or dosage form.

$2,420

15. Chemistry & manufacturing for change in packaging or sterilization.

$1,930

16. Chemistry & manufacturing for extension of expiry date.

$1,450

17. Chemistry & manufacturing for concurrent use of 2 drugs.

$1,450

18. Chemistry & manufacturing for change in manufacturing site (parenteral or sterile).

$480

19. Change in manufacturer or brand name of a drug. (Applies only where a SNDS does not include any of the above components.)

$250

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature: Date:

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Product Name:

Submission No.: File No.:

Section 3: Abbreviated New Drug Submission or Supplement to an Abbreviated New Drug Submission

HC Protected

Component

Fee

x no.

Enter fee here

HPFB Use Only

1. Any applicable component listed in Section 2.

See
Section 2

2. Comparative (pharmacodynamic, clinical or bioavailability) data for one route & dosage form.

$2,900

3. For food 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 & manufacturing for non-compendial medicinal ingredient. (A medicinal ingredient previously evaluated within the last 3 years, to which reference is made is not required to be re-evaluated.)

$4,840

5. Chemistry & manufacturing for 1 dosage form.

$4,840

6. Change in manufacturer or brand name of a drug. (Applies only where an abbreviated submission does not include any of the above components.)

$250

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature:   Date:

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Product Name:

Submission No.:  File No.:

Section 4: DIN Application

HC Protected

Component

Fee

x no.

Enter fee here

HPFB Use Only

1. Information (other than item 2 below) for DIN application, including the submission of labelling for a second review, if required.

$720

2. Published references or other data.

$500

3. Change in manufacturer or brand name of a drug. (Applies only where a DIN application does not include any of the above components.)

$250

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature:   Date:

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Product Name:

Submission No.:   File No.: /p>

Section 5: Preclinical (Investigational) New Drug Submission

HC Protected

Component

Fee

x no.

Enter fee here

HPFB Use Only

1. Efficacy & safety data (intended species) & protocol for the conduct of clinical studies for one dosage form, route & indication in 1 species.

$4,840

2. Efficacy data & protocol for the conduct of clinical studies for one route & indication with a dosage form for which a NOC has been issued for use in that species.

$3,870

3. For food animals, toxicity, metabolism & residue depletion studies to establish a temporary ADI, MRL & a withdrawal period for one dosage form, dosage & route in 1 species.

$14,520

4. For food animals, toxicity, metabolism & residue depletion studies to establish an ADI with a SF of 1,000, a MRL & a withdrawal period for one dosage form, dosage & route in 1 species.

$21,790

5. For food animals, toxicity, metabolism & residue depletion studies to establish an ADI with a SF of <1,000, a MRL & a withdrawal period for one dosage form, dosage & route in 1 species.

$29,050

6. For food animals (once a ADI and a SF of #1,000 has been established), metabolism studies to establish a withdrawal period for one dosage form, dosage & route in an additional species.

$7,260

7. Chemistry & manufacturing for 1 dosage form with a noncompendial medicinal ingredient. (A medicinal ingredient previously evaluated within the last 3 years, to which reference is made is not required to be re-evaluated. In that case, the fee for item 8 would apply.)

$4,840

8. Chemistry & manufacturing for 1 dosage form with a compendial medicinal ingredient.

$2,420

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature:  Date:

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Product Name:

Submission No.:  File No.:

Section 6: Notifiable Change or Protocol Review

HC Protected

Component

Fee

x no.

Enter Fee Here

HPFB Use Only

1. Information & material to support an application for a Notifiable change.

$1,300

2. Request for review of scientific information outside of a regular drug submission (i.e. review of a proposed trial protocol).

$1,300

Total Fee

HPFB use only

Fee assessment verified by (print):

Signature:   Date: