"Veterinary Drug Experimental Studies Certificate (Esc) Application Form" - Canada

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Protected B (When Completed)
Veterinary Drugs Directorate (VDD)
Health Products and Food Branch (HPFB)
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
Experimental Studies Certificates (ESCs) may be issued by Health Canada to approve the conduct of a variety of
veterinary drug studies, such as preliminary research, immobilization procedures (e.g. for wildlife issues), and to
generate data to support a veterinary drug regulatory submission in Canada. To apply for an ESC, an application
form and required attachments must be submitted to Health Canada for review. This application form supports all
ESC requests. The instructions for the application form explain the information required.
If the total attachments are less than 20 MB, you may send the complete application package by email to:
vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Important notes:
o
Veterinary drugs used in experimental studies are covered by sections C.08.013-C.08.018 of the Food and Drug
Regulations. Fees for ESCs are outlined in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order
(subject to annual adjustments based on Consumer Price Index). Fees may be waived or reduced for small businesses.
Note that Canadian Federal, Provincial and Territorial Government Departments and publicly funded health care
institutions do not have to pay a fee for an ESC, but must submit the ESC application and all necessary accompanying
documents.
o
An ESC is valid for 12 months. If a date extension is required, a renewal should be filed before the end of the 12 month
period.
o
One site is typically permitted per ESC application; where a single protocol is to be used for multiple sites and for other
situations, contact VDD for assistance:
vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.
o
For all ESCs involving aquaculture: VDD’s evaluation will include considerations for environmental risk
mitigation and notification of the appropriate provincial/territorial or federal departments that oversee aquaculture
in each jurisdiction; and aquaculture facilities will be required to fulfill all requirements and deposit reporting
under the
Aquaculture Activities Regulations
(AAR).
o
Controlled Drugs are listed under the
Schedules of the Controlled Drugs and Substances
Act. For studies using
controlled drugs, an ESC application must be sent to VDD, and an application exemption must be sent to the
Office of Controlled Substances. For information about the application exemption, email
exemption@hc-sc.gc.ca.
o
Upon the coming into force of the Cannabis Act on October 17, 2018, for studies using cannabis (as defined
under the Cannabis Act), an ESC application must be sent to VDD, and a research licence application must be
sent to the Controlled Substances and Cannabis Branch (CSCB). For information about the research licence
application, email:
cannabis@hc-sc.gc.ca
.
2020-04-01
Protected B (When Completed)
Veterinary Drugs Directorate (VDD)
Health Products and Food Branch (HPFB)
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
Experimental Studies Certificates (ESCs) may be issued by Health Canada to approve the conduct of a variety of
veterinary drug studies, such as preliminary research, immobilization procedures (e.g. for wildlife issues), and to
generate data to support a veterinary drug regulatory submission in Canada. To apply for an ESC, an application
form and required attachments must be submitted to Health Canada for review. This application form supports all
ESC requests. The instructions for the application form explain the information required.
If the total attachments are less than 20 MB, you may send the complete application package by email to:
vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Important notes:
o
Veterinary drugs used in experimental studies are covered by sections C.08.013-C.08.018 of the Food and Drug
Regulations. Fees for ESCs are outlined in Schedule 2 of the Fees in Respect of Drugs and Medical Devices Order
(subject to annual adjustments based on Consumer Price Index). Fees may be waived or reduced for small businesses.
Note that Canadian Federal, Provincial and Territorial Government Departments and publicly funded health care
institutions do not have to pay a fee for an ESC, but must submit the ESC application and all necessary accompanying
documents.
o
An ESC is valid for 12 months. If a date extension is required, a renewal should be filed before the end of the 12 month
period.
o
One site is typically permitted per ESC application; where a single protocol is to be used for multiple sites and for other
situations, contact VDD for assistance:
vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.
o
For all ESCs involving aquaculture: VDD’s evaluation will include considerations for environmental risk
mitigation and notification of the appropriate provincial/territorial or federal departments that oversee aquaculture
in each jurisdiction; and aquaculture facilities will be required to fulfill all requirements and deposit reporting
under the
Aquaculture Activities Regulations
(AAR).
o
Controlled Drugs are listed under the
Schedules of the Controlled Drugs and Substances
Act. For studies using
controlled drugs, an ESC application must be sent to VDD, and an application exemption must be sent to the
Office of Controlled Substances. For information about the application exemption, email
exemption@hc-sc.gc.ca.
o
Upon the coming into force of the Cannabis Act on October 17, 2018, for studies using cannabis (as defined
under the Cannabis Act), an ESC application must be sent to VDD, and a research licence application must be
sent to the Controlled Substances and Cannabis Branch (CSCB). For information about the research licence
application, email:
cannabis@hc-sc.gc.ca
.
2020-04-01
2 |
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
Refer to the Instructions (pages 10-14) for additional information to help you
complete your application package.
Part 1 – Nature of the Proposed Experimental Study
A)
Indicate which option best describes this Experimental Studies Certificate (ESC) Application:
A new study
A study with an identical protocol to that for a previously issued ESC:
Drug Submissions Tracking System (DSTS) # of previous ESC:
No
Is this application a renewal of an ESC approved within the last 12 months?
Yes
An amendment to an ESC approved within the last 12 months
DSTS# of previous ESC:
B)
Is this study intended to generate data to support a veterinary drug regulatory submission in Canada?
Yes
No
C)
Does this study include the immobilization of wildlife?
Yes
No
Part 2 – Investigator & Billing Information
D)
Investigator Information
Investigator Name:
Investigator Title:
Investigator’s Company/Organization:
Mailing Address:
Street/Suite
City/Town
Province
Postal Code
Telephone Number
Email
Fax Number
Primary contact (If different from investigator):
Yes
No
Third Party authorization letter attached:
Title
Company/Organization
Email
Telephone Number
3 |
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
E) Billing Information
The full ESC application fee will be invoiced once the submission has been accepted into review. If the ESC
application is not accepted for review, 10% of the full fee will be invoiced.
Contact Name and Title:
Company Name:
Mailing Address:
Street/Suite
City/Town
Province/State
Country
Postal Code/Zip Code
Email
Telephone Number
Fax Number
Fee Mitigation Measures
The following fee mitigation measures are available. Sponsors must certify that they meet the criteria as outlined in the Food and
Drug Regulations.
Small Business
We certify that we meet the definition of small business at the time of this filing and have applied for small business status for our
company with Health Canada and have received confirmation prior to submitting this submission/application. We understand that failure
to hold a valid small business status with Health Canada at the time of submitting this submission/application will result in the full fee
being charged.
We have not previously filed an application in respect of a drug with Health Canada
.
. We are filing our first drug application.
Publicly Funded Health Care Institution
We certify that our institution is funded by the Government of Canada or the government of a province or territory and that it is
a)
licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment
to persons or animals suffering from any form of disease or illness; or
b)
owned or operated by the Government of Canada or the government of a province and that provides health services.
Government Organization
We certify that our organization is a branch or agency of the Government of Canada or of a province or territory.
Part 3 – Drug and Supplier Information
Drug 1- Information
F) Brand Name (or identifying name or code)
G) Proper or Common Name
H) Dosage Form
I) Route of Administration
J) Chemical Structure – diagram attached (if known):
Yes
No
K) Package / Vial Size
L) Formulation
4 |
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
Medicinal (Active) Ingredient(s)
Active Ingredient Name
Standard
Strength
Units
Per
Calculated as
(Include CAS # if known)
Base (Y/N)
Yes
No
Yes
No
Yes
No
Yes
No
Non-medicinal Ingredient(s) (including preservatives, colouring agents)
Non-medicinal Ingredients
Calculated as
Standard
Strength
Units
Per
(Include CAS # if known)
Base (Y/N)
No
Yes
Yes
No
Yes
No
Yes
No
No
Yes
M) List any other drugs to be used in the study
To add additional lines, choose [Tab] to create a new line.
Drug Name
DIN (if approved)
N) Indicate how the other drugs will be obtained (select all that apply):
Available Over-the-counter
Veterinarian or Veterinary Prescription
Supplier using this Experimental Studies Certificate (all products outlined on these forms)
Other (specify):
5 |
Veterinary Drug Experimental Studies Certificate (ESC) Application Form
O) Drug 1 - Supplier Information
Company Name:
Contact Name:
Mailing Address:
Street/Suite
City/Town
Province/State
Country
Postal/Zip Code
Email
Telephone Number
Fax Number
Drug 2 - Information (if more than one drug is part of this ESC application)
F) Brand Name (or identifying name or code)
G) Proper or Common Name
H) Dosage Form
I) Route of Administration
J) Chemical Structure – diagram attached (if known):
Yes
No
K) Package / Vial Size
L) Formulation
Medicinal (Active) Ingredient(s)
Active Ingredient Name
Standard
Strength
Units
Per
Calculated as
(Include CAS # if known)
No
Yes
Yes
No
Yes
No
No
Yes
Non-medicinal Ingredients (Including preservatives, colouring agents)
Non-medicinal Ingredients
Calculated as
Standard
Strength
Units
Per
(Include CAS # if known)
Base (Y/N)
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
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