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._________________
__________________________________________________
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: _______________
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: _______________
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: _______________
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: _______________
Product Name: ____________________________________
Submission No.: _________________ File No.: __________
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: _______________
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: _______________
|
