Application Form For An Exemption To Use A Controlled Substance For Scientific Purposes

1. Application Type

• New
• Extension (no additional quantities)
• Extension (additional quantities)
• Amendment of exemption
• Cancellation of exemption
• Transfer of responsibility of the project

2. Identification

1. Principal investigator:
   • Mr.
   • Mrs.
   • Ms.
   • Dr.
   • Surname:
   • Given name:
   • Middle Initials:
2. If this is not a new application please indicate the current authorization number
3. Title and qualifications: (Minimum requirement: B.Sc. in an appropriate field)
   • B.Sc.
   • M.Sc.
   • Ph.D.
   • M.D.
   • D.V.M.
   • D.M.D.
   • D.D.S
   • Licence Number:
   • Field of study:
   • Telephone:
   • Facsimile:
   • E-mail
   • Alternate contact name:
   • Alternate contact e-mail:
4. Address: (where the substance will be used)
   • Institution/Company:
   • Department:
   • Faculty:
   • Street:
   • Room:
   • City:
   • Province:
   • Postal Code:
5. Mailing address: (if different from above)
   • Institution/Company:
   • Department:
   • Faculty:
   • Street:
   • Room:
   • City:
   • Province:
   • Postal Code:

3. Project or Study Description

1. Project Title (Same as protocol)
2. Required Documents:
   • Protocol attached
   • Protocol previously submitted, if not amended
   • Approval of the Animal Care Committee (for in vivio studies)
   • Note: A Copy of the protocol of the project and the Approval of the Animal Care Committee (if applicable) must be submitted
3. Brief description of the use of the substance:
4. Reason for requiring an extension, cancellation or transfer of responsibility (if applicable)

4. Details of Administration

• In vitro utilization (Go to number 5)
• In vivo administration

• Animal species:
• Number of animals: (To be used under this exemption)
• Average weight per animal:
• Animal carcasses will be disposed of by:
  • Incineration
  • Other (please specify)

1. Name of Controlled Substance:
   • Initial dose:
   • Maintenance dose:
   • Frequency:
   • Total dose:
2. Name of Controlled Substance:
   • Initial dose:
   • Maintenance dose:
   • Frequency:
   • Total dose:
3. Name of Controlled Substance:
   • Initial dose:
   • Maintenance dose:
   • Frequency:
   • Total dose:

5. Supplier of the Controlled Substance

*The quantity required is an estimate of quantity needed for a maximum period of one year. Attach additional copies of this page as necessary. *Please note that if the substance is unavailable in Canada, the Office of Controlled Substances will import on behalf of the applicant. In such cases, the applicant must provide a copy of the completed Import Order Authorization and Permit Application Form. Importation may take up to 3 months.

• Controlled Substance:
• Foreign supplier (see Appendix 1)
• Brand name:
• Concentration (if applicable):
• Quantity required for all submitted protocols:
• Quantity in inventory: (From previous exemption, if applicable)
• Quantity to be purchased:
• Supplier:
• Address:
• Telephone:
• Contact Name:

6. Physical Security

• Description of physical storage and security measures to be used:
• *Please note: Security must meet the requirements of the "Directive on Physical Security Requirements for Controlled Substances", available on the Health Canada website http://www.hc-sc.gc.ca/hc-ps/substancontrol/substan/securit-eng.php

7. Declaration

7.1 Application Type: New, extension or amendment

I hereby certify that I am the principal investigator and that the controlled substance(s) will be used for scientific purposes mentioned in this application. I have read and understand the Directives on Physical Security Requirements of controlled substances and other requirements specified in the Controlled Drugs and Substances Act and its Regulations. The specified requirements are met, or will be met before I commence any activity associated with any exemption issued to me.

I also agree to comply with any terms and conditions that may be specified in any exemption issued to me.

• Principal investigator:
• Date:

7.2 Application type: Cancellation

• I hereby certify that the exemption with authorization number [...] is no longer required.
• I attest that the total quantity of controlled substance was used an that there is no remaining inventory.
• I attest that there is a quantity of controlled substance remaining and it will be used for the protocol titled [...] under existing authorization number [...].
• I attest that there is a quantity of controlled substances remaining and it will be destroyed in accordance with the process outlined in section 3.0 in the Guidance Document "Application to Use Controlled Substances for Scientific Purposes".
• Principal investigator:
• Date:

7.3 Application type: Transfer

I hereby certify that I am transferring the controlled substance(s) named in the exemption with authorization number [...] to [...], the Principal Investigator taking over responsibility of the project. The quantities being transferred are:

• Name of Controlled Substance(s)
• Quantity Remaining
• Outgoing Principal Investigator:
• Date:
• Incoming Principal Investigator:
• Date:

Checklist for an Application for an Exemption to use a Controlled Substance for Scientific Purposes

This checklist is provided to assist you in ensuring that all the required information has been included in your application for an Scientific Exemption. Incomplete applications will be put on hold until the required information is received.

• Section 1: Application Type.
• Section 2: Exemptions are issued to the Principal Investigator of each protocol. The address on the application is where the substance will be used.
• Section 3: The project title must be the same as the protocol. With a brief description of the use of the Controlled Substance.
  • A Copy of the protocol is attached with the application form or has been previously submitted if there is no amendment.
  • The approval from the Animal Care Committee (if applicable).
• Section 4: Only include the number of animals and dosing information to be used under this exemption. For multi-year protocols, this number is the number to be used in one year.
• Section 5: Full Details concerning the purchase of each controlled substance is required.
• Section 6: A description of storage and security that will meet the requirements of the "Directive on Physical Security Requirements for Controlled Substances".
• Section 7: The declaration must be signed and dated by the principal investigator, or in the case of a transfer, both the incoming and outgoing principal investigators, and the original form submitted to our office.

Note: Additional copies of sections 4 and 5 may be submitted if required.

Please submit the completed original application form and all accompanying documents to:

Evaluation and Authorization Division
Office of Controlled Substances
Tobacco and Drugs Directorate
Healthy Environments and Consumer Safety Branch
Health Canada, AL 3502B
123 Slater St 2nd Floor
Ottawa ON K1A 1B9

Note: Faxed applications will no longer be accepted.

For further information, you may contact Evaluation and Authorization Division by phone at (613) 952-2219 or (613) 957-1063 or by e-mail at exemption@hc-sc.gc.ca

Appendix 1

Import Order Authorization and Permit Application Form for the import of controlled drugs and substances including precursor chemicals by the OCS Licensed Dealer.

The importation process will be initiated once an exemption for research purposes has been granted to the applicant pursuant to section 56 of the Controlled Drugs and Substances Act. Please ensure that your order is placed with the supplier prior to submitting this form.

Note : This request is valid for one shipment only.

• Purchaser Information
  • Name of Principal Investigator
  • Shipping Address
  • City
  • Province
  • Postal Code
  • Contact Person
  • Telephone Number
  • Fax Number
• Order Information
  • Supplier Name
  • Supplier Contact Name
  • Supplier Phone #
  • Supplier Address
  • Product Name
  • Catalogue #
  • Substance Name
  • Quantity
  • Purolator Account #
  • Purchase Order # (PO)
• Certification
  • I hereby certify that for the above mentioned order, of which I am the requesting, all costs associated with the importation, including cost of substance(s), customs duties and shipping of permit(s) and substance(s), will be paid by the applicant to the supplier.
  • Name:
  • Signature:
  • Date:

Please mail the completed form to:

Evaluation and Authorization Division
Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
123 Slater St
AL 3502B
Ottawa ON K1A 1B9

• For Internal Use Only
  • Pursuant to the provision of the Controlled Drugs & Substances Act, application is hereby made for a permit to import the controlled substance listed above.
  • HC Auth #
  • Import Permit #
  • Valid to:
  • Port of Entry : Ottawa
  • QPIC Signature:
  • Date:
  • Conveyance : Air