Application for an Experimental Studies Certificate for a Veterinary Drug

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Table of Contents

Part 1 - Investigator/Billing/Manufacturer/Fee Information

A) Investigator Information
B) Billing Information
C) Manufacturer Information
D) Fees

Part 2 - Drug Information

Part 3 - Experimental Study Details

Part 4 - Food-Producing Animals Only

Part 5 - Statement(s) of Investigator

Instructions for Completing the Experimental Studies Certificate Form

Part 1- Investigator/Billing/Manufacturer/Fee Information
Part 2 - Drug Information
Part 3 - Experimental Study Details
Part 4 - Required for Food-Producing Animals Only
Part 5 - Statement of Investigator

Conditions of Sale
Experimental Studies Certificate
Labelling
Conditions of Experimental Study
Suspension or Cancellation of Experimental Studies Certificate

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This application form has been created to assist applicants in submitting the information required to receive an Experimental Studies Certificate (ESC) for a veterinary drug.

The completed application, fee and accompanying information is to be sent to:

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

Instructions for completing the form are found on pages 5 and 6, followed by Sections C.08.013 to C.08.018 of the Food and Drugs Act and Regulations which refer specifically to the Experimental Studies certificates.

Please Note:

• Generally one site is permitted per Experimental Studies Certificate, therefore a separate form and fee are required for each study site;
  
  
• An Experimental Studies Certificate is not required for studies with laboratory animals provided the study is carried out in-house by the drug manufacturer;
  
  
• Canadian government departments do not have to pay a fee for an Experimental Studies Certificate, but still must submit the application form;
  
  
• Controlled Drug Substances are listed under the Schedule of Part G of the Food and Drugs Act and Regulations.

Although the Veterinary Drugs Directorate (VDD) does not issue Experimental Studies Certificates (ESC) for Controlled Drug Substances, an ESC application must still be made to the Veterinary Drugs Directorate. Once the ESC application has been reviewed, the application and all VDD recommendations are forwarded to the Office of Controlled Substances, Healthy Environments and Consumer Safety (HECS) Branch in Health Canada for the final decision to release the particular Controlled Drug Substance to the ESC applicant. It is expected that pertinent VDD recommendations will also be forwarded by the Office of Controlled Substances to the ESC applicant, should the decision be to release the Controlled Drug Substance.

Experimental Studies Certificate Fee and Application Form

Part 1 - Investigator/Billing/Manufacturer/Fee Information

HC Use Only:

ESC No.   File No.

Date of Receipt   $ Amount Received

Customer No.   Invoice No.

SO No.

A) Investigator Information

Investigator Name

Investigator Title

Street/Suite/PO Box

City/Town    Province

Postal Code   Telephone No.

Fax No.   E-mail

Language Preferred     English     French

B) Billing Information (if different)

Billing Contact Person

Street/Suite/PO Box

City/Town   Province

Postal Code   Telephone No.

Fax No.   E-mail

Language Preferred English French

C) Manufacturer Information

Company Name

Product Name

Street/Suite/PO Box

City/Town   Province

Postal Code

Contact Name

Telephone No.   Fax No.

E-mail

D) Fees

1. Information for one ESC for one drug administered to a non-food animal species.
   
   Fee $960 Fee Payable
   
   HC Use Only
   
   
   
2. Information for one ESC for one drug to be administered to a food-producing animal species.
   
   Fee $2,900 Fee Payable
   
   HC Use Only
   
   
   
3. Information for one ESC, whose protocol is the same as that for a previously issued ESC, for the same drug administered to:
   
   food-producing     or non-food-producing     animal species.
   
   Fee $480 Fee Payable
   
   HC Use Only

Fees Paid:

    By cheque

Cheque Number

    By Credit Card

Master Card No.:

Visa No.:

Expiry date:   Cardholder:

    By Wire

    By Purchase Order - P.O. No.:

Part 2 - Drug Information

E) Brand Name (or identifying name or code)

F) Proper or Common Name

G) Dosage Form

H) Route of Administration

I) Chemical Structure - diagram attached:    

J) Formulation

Medicinal (Active) Ingredient(s)

Standard Strength

Separate sheet attached (same format) if necessary.    

Non-medicinal Ingredients (including preservatives, colouring agents)

Standard Strength

Separate sheet attached (same format) if necessary.    

K) Labelling - Copies of labelling, including package inserts attached    

Part 3 - Experimental Study Details

L) Study Location

M) Facility Description - details attached    

N) Study Objective

O) Study Protocol, including outline - details attached    

P) Name and Qualifications of Principal Investigator - details attached    

Q) Animals to be Studied:

Species:  Number:  Production Type:

R) Study Duration

S) Quantity of Drug required for the Experimental Study

T) Data regarding safety and efficacy of the drug in the intended species attached     - (Please see instructions for this item)

Part 4 - Food-Producing Animals Only

U) Proposed Withdrawal Period:

Meat   Milk   Eggs   Other  

V) Toxicity and residue data attached.    

W) Statement of Owner or Manager of Animals

I agree not to sell the animal(s) used in the Experimental Study, or any products from it (them) without prior written authorization from the Experimental Studies Investigator, .
(Name of investigator)

Owner/Manager Name (print)

Owner/Manager address

Signature   Date

Part 5 - Statement(s) of Investigator

Note: Principal Investigator must sign and date the Statement of Investigator X). Y) is only required if the ESC is for a food-producing animal. Z) is only required if it is for race horses.

I agree to

1. use the new drug only in accordance with the outline of the experimental study
   
   
2. report immediately to the Veterinary Drugs Directorate all serious adverse reactions associated with the use of the new drug;
   
   
3. report promptly to the Veterinary Drugs Directorate, on request, the results of the experimental study;
   
   
4. return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;
   
   
5. maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Veterinary Drugs Directorate;
   
   
6. report promptly to the Veterinary Drugs Directorate any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014 (2)(Food and Drugs Act and Regulations); and
   
   
7. account to the Veterinary Drugs Directorate, on request, for all
   quantities of the new drug received by me.

X) Signature of Investigator   Date

Investigators Statement for Food-Producing Animals In addition to the above statement, I agree to

1. use a federally inspected abattoir for the slaughter of any animals which were used in this Experimental Study;
   
   
2. notify the veterinarian-in-charge of this abattoir in advance of the slaughter date; and
   
   
3. notify the Canadian Food Inspection Agency at least 10 days before an anticipated slaughter date of any animals which were used in this
   Experimental Study, providing the Agency the name and address of the abattoir which will be used for this slaughter.

Y) Signature of Investigator (Food-Producing Animals)

Date

Investigators Statement for Race Horses

I am responsible for ensuring that this drug is used in compliance with the Pari-Mutuel Betting Supervision Regulations administered by the Canadian Pari-Mutuel Agency (CPMA).

Z) Signature of Investigator (Race Horses)

Date

Instructions for Completing the Experimental Studies Certificate Form

References from the Food and Drugs Act and Regulations are included where applicable

Part 1- Investigator/Billing/Manufacturer/Fee Information

Section A

Provide complete contact information regarding the Principal Investigator for the Experimental Studies Certificate. This should be the same person who signs in block W. C.08.014(1)(g)

Section B

Provide the name and contact information for the person who will pay the bill, if different than in block A

Section C

Provide a contact name and address for the drug manufacturer who can answer any questions which may arise during the evaluation of the ESC. C.08.014(1)(d)

Section D

The fee guide for an ESC. The fee must be paid before the evaluation will be started. The fee will be verified when the application is screened, and the Investigator will be contacted if the correct fee has not been paid.

Except for the condition(s) indicated on the cover page of this form, there is a fee levied for all ESCs, whether they are for Controlled Drug Substances or not.

Part 2 - Drug Information

Section E

The brand name is the name assigned by the manufacturer/sponsor to distinguish the drug (product) and under which the drug is to be sold /advertised. The brand name is also the name used to identify the product in all correspondence related to the submission and on the product labelling. If the product name has not yet been determined, the proper or common name of the drug or the research code may be used. C.08.014(1)(a)

Section F

The proper name is the name assigned to the drug in section C.01.002 of the Food and Drugs Act and Regulations, or in boldface type in other sections of the regulations or the name of the drug in its finished form identified in the title of a monograph or in any of the official publications listed in Schedule B to the Food and Drugs Act.

The common name is the name by which a single ingredient drug is commonly known/designated in the scientific or technical journals other than the publications referred to in Schedule B to the Food and Drugs Act and Regulations. The common name includes the pharmaceutical form when used in relation to the finished drug product.

If there is no proper name and the drug is comprised of more than one medicinal ingredient, leave F blank.

Section G

Identify the proposed dosage form (pharmaceutical form) of the drug product, eg., tablet, capsule, cream.

Section H

Indicate the proposed route(s) of administration, eg., oral, intravenous, topical.

Section I

Attach a diagram of the chemical composition of the drug. C.08.014(1)(h)

Section J

Please provide as complete a formulation as possible. List the medicinal (active) ingredients that contribute to the proposed use of the product by its/their proper or common name(s).

Include the strength of the active ingredients and the standard, (USP, BP, etc.). Where the specifications for ingredient manufacture deviate from and exceed or are equivalent to the compendial standard, manufacture's standard may be indicated. List the non-medicinal ingredients separately. Include preservatives and colouring agents, if applicable. Attach other sheets if necessary C.08.014(1)(h)

Section K

Attach a copy of all labelling for the drug, including package insert. It is the responsibility of the drug manufacturer to ensure that this drug is labelled in accordance with section C.08.016 of the Food and Drugs Act and Regulations.

Part 3 - Experimental Study Details

Section L

Provide the name and address of the facility. C.08.014(1)(e) Note: There are some circumstances where a study may include multiple sites. These should be discussed with VDD staff before an application is made.

Section M

Attach a description of the facilities to be used for the study. C.08.014(1)(f)

Section N

Briefly state the objective of this Experimental Study. C.08.014(1)(b)

Section O

Attach the detailed protocol of the Experimental Study. Describe in detail how the study is to be conducted. Include an outline of the study. C.08.014(1)(b)

Section P

Describe the qualifications of the Principal Investigator. Include academic degrees; affiliations (schools, clinics, etc.); and teaching, research, or other professional experience (including experience in the investigation of new drugs). C.08.014(1)(g)

Section Q

Animal to be studied: Species, number (experimental, control), production type. C.08.014(1)(c)

Section R

Provide the anticipated time-frame of the Experimental Study.

Section S

State the amount of the experimental drug required to complete the ESC. C.08.014(1)(I)

Section T

Provide information regarding the safety and efficacy of the drug in the intended species (toxicological or pharmaceutical studies, etc.) This data is essential in the review of the ESC application. Data regarding the use of the drug in other species (besides the species in this Study) should also be included. C.08.014(1)(j)

Part 4 - Required for Food-Producing Animals Only

Section U

Provide the proposed withdrawal period for any applicable uses of the animal(s) or products. The withdrawal period to be used will be determined after evaluation by the Human Safety Division, Veterinary Drugs Directorate.

Section V

Provide any available information pertaining to the toxicity and residue of the drug for use by Human Safety Division in their evaluation. C.08.014(1)(j)

Section W

The owner of the animal(s) to be used in the study must complete and sign the declaration. C.08.014(1)(k)

Part 5 - Statement of Investigator

Section X

The investigator must sign this declaration.

Section Y

Investigator of food-producing animals must sign this declaration as well as X. The Veterinary Drugs Directorate will inform the appropriate provincial Milk Marketing board of the issuance of an ESC for dairy cattle by copy of the ESC letter.

Section Z

Investigator of race horses must sign this declaration as well as X. If this drug is used in race horses, the investigator is responsible for ensuring that it is used in compliance with the Pari-Mutuel Betting Supervision Regulations administered by the Canadian Pari-Mutuel Agency (CPMA). The Veterinary Drugs Directorate will advise the CPMA by copy of the ESC letter.

Division 8 of the Food and Drugs Act and Regulations refers to New Drugs. Sections C.08.013 to C.08.018 refer specifically to Experimental Studies. This is not an official copy and is provided for your convenience only.

Conditions of Sale

C.08.013.

1. Notwithstanding anything in this Division, a person may sell a new drug proposed for use in animals to an experimental studies investigator in a quantity specified by the Director for the purpose of conducting an experimental study in animals if
   
   
   1. the experimental studies investigator has been issued an experimental studies certificate pursuant to subsection C.08.015(1) and the certificate has not been suspended or cancelled pursuant to section C.08.018; and
      
      
   2. the drug is labelled in accordance with subsection C.08.016(1).
      
      
2. For the purposes of this section and sections C.08.014 to C.08.018,
   "experimental studies certificate" means a certificate issued pursuant to subsection C.08.015(1); "experimental studies investigator" means a person named as the investigator in an experimental studies certificate; "experimental study" means a limited test of new drug in animals carried out by an experimental studies investigator.

Experimental Studies Certificate

C.08.014.

1. For the purpose of obtaining an experimental studies certificate, an applicant shall submit to the Director, in writing, the following information and material:
   
   
   1. the brand name of the new drug or the identifying name or code proposed for the new drug;
      
      
   2. the objectives and an outline of the proposed experimental study of the new drug;
      
      
   3. the species, number and production type of animals in respect of which the new drug is to be administered;
      
      
   4. the name and address of the manufacturer of the new drug;
      
      
   5. the address of the premises in which the experimental study is to be conducted;
      
      
   6. a description of the facilities to be used to conduct the experimental study;
      
      
   7. the name, address and qualifications of the proposed experimental studies investigator;
      
      
   8. the chemical structure, if known, and the relevant compositional characteristics of the new drug;
      
      
   9. the proposed quantity of the new drug to be used for the experimental study;
      
      
   10. the results of any toxicological or pharmacological studies that may have been conducted with the new drug;
       
       
   11. the written agreement referred to in subsection (2); and
       
       
   12. such other information and material as the Director may require.
       
       
2. Where a food-producing animal is involved in an experimental study, the applicant referred to in subsection (1) shall, for the purposes of obtaining an experimental studies certificate, obtain from the owner of the animals, or from a person authorized by the owner, a written agreement not to sell the animal or any products from it without prior authorization from the experimental studies investigator.
   
   
3. The Director may request the manufacturer of a new drug to submit to him samples of the new drug or of any ingredient of the drug and, in satisfactory form and manner, any other information that the director requests and where such samples or information are not submitted, the Director may refuse to issue an experimental studies certificate.

C.08.015.

1. Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is satisfied that
   
   
   1. the applicant is qualified as an experimental studies investigator for the purposes of the proposed experimental study
      
      
   2. the facilities for the conduct of the experimental study are adequate for the purposes of the proposed experimental study, and
      
      
   3. the proposed experimental study can be conducted without undue foreseeable risk to humans or animals, the Director shall issue an experimental studies certificate for the purposes of the proposed experimental study and shall specify therein the quantity of the new drug that may be sold to the experimental studies investigator.
      
      
2. Where, on receipt of the information and material submitted pursuant to section C.08.014, the Director is not satisfied that the requirements of paragraphs (1)(a), (b) and (c) have been met, he shall refuse to issue an experimental studies certificate.

Labelling

C.08.016.

1. The label of new drug that is sold pursuant to section C.08.013 shall show
   
   
   1. the brand name of the new drug or the identifying name or code proposed for the new drug;
      
      
   2. a warning statement to the effect that the drug is for use only in an experimental study in animals;
      
      
   3. the lot number of the drug;
      
      
   4. the name and address of the manufacturer of the drug; and
      
      
   5. the name of the person to whom the drug has been supplied.
      
      
2. Sections C.01.004, C.01.005 and C.01.014 do not apply to a drug that is sold pursuant to section C.08. 013 and labelled in accordance with subsection (1).

Conditions of Experimental Study

C.08.017. An experimental studies investigator shall

1. use the new drug only in accordance with the outline of the experimental study;
   
   
2. report immediately to the Director all serious adverse reactions associated with the use of the new drug;
   
   
3. report promptly to the Director, on request, the results of the experimental study;
   
   
4. return to the manufacturer, on request, all quantities of the new drug not used in the experimental study;
   
   
5. maintain all records of the experimental study for a period of at least two years after the conclusion of the study and, on request, make such records available to the Director;
   
   
6. report promptly to the Director any known disposition of animals involved in the study or of any products from the animals that is contrary to the terms of the agreement referred to in subsection C.08.014 (2); and
   
   
7. account to the Director, on request, for all quantities of the new drug received by him.

Suspension or Cancellation of Experimental Studies Certificate

C.08.018.

1. Where the Director is of the opinion that it is necessary in order to safe guard animal health or public health or to promote public safety, he may suspend for a definite or indefinite period or cancel an experimental studies certificate.
   
   
2. Without limiting the generality of subsection (1) , the Director may suspend or cancel an experimental studies certificate if
   
   
   1. the information and material submitted pursuant to section C.08.014 contains an untrue statement or contains any omission concerning the properties of the drug that were known or ought reasonably to have been known to the manufacturer of the experimental studies investigator;
      
      
   2. the labelling of the new drug is, at any time, false, misleading, deceptive or incomplete;
      
      
   3. the qualifications of the experimental studies investigator prove to be inadequate;
      
      
   4. there is evidence that the experimental studies investigator has not complied with the conditions referred to in section C.08.017; or
      
      
   5. an action of the manufacturer in respect of the new drug has resulted in his conviction for a violation of section C.08.002.