Application Form For An Exemption To Use A Controlled Substance For Clinical Studies

1. Identification

• Applicant:
  • Mr.
  • Mrs.
  • Ms.
  • Dr.
• Surname:
• Given name:
• Initials:
• Title and qualifications:
  • M.D.
  • D.V.M.
  • D.M.D.
• Field of study:
• Licence Number:
• Address (where the substance will be used)
• Tel. Number:
• Fax Number:
• E-mail address:
• Mailing address (if different from above)
  • Institution:
  • Department/Faculty:
  • Street:
  • Room:
  • City:
  • Province:
  • Postal Code:
• Language of correspondence
  • English
  • French

2. Application Type

• New
• Amendment
• Extension of exemption period
• Cancellation
• Transfer of responsibility of the substance from one person to another

3. Project Description

• Title:
• Objective:
• Project description:
  • See attachment(s)
• In vitro utilization
• Administration to human subjects (in vivo)
• Number of subjects:
• Dose:
• Frequency:
• Total dose:
• OCS only (detailed calculations)

4. Description Of The Controlled Substance

• Name of substance:
• Amount requested^{Footnote 1}
• Amount in inventory
• Commercial format (e.g. conc.)
• Supplier (Name, address, telephone number, contact)

• Name of substance:
• Amount requested^{Footnote 1}
• Amount in inventory
• Commercial format (e.g. conc.)
• Supplier (Name, address, telephone number, contact)

• Name of substance:
• Amount requested^{Footnote 1}
• Amount in inventory
• Commercial format (e.g. conc.)
• Supplier (Name, address, telephone number, contact)

5. Physical Security

• Description of type of storage and security:

N.B.: Please note that particular arrangements may prove necessary if the required security level is not met. The Office of Controlled Substances will contact the applicant, if necessary.

6. Declaration

I hereby certify that the information provided in the application and in all the attached documents is complete and accurate and complies with all the relevant sections of the Controlled Drugs and Substances Act and Regulations.

I hereby certify that the controlled substance(s) is(are) being used for scientific purposes.

• Applicant's signature:
• Date:
• Attachment(s)

Please send the application to the address below:

Evaluation and Authorization Division
Office of Controlled Substances
Drug Strategy and Controlled Substances Programme
Healthy Environments and Consumer Safety Branch
Health Canada, A.L.: 3502B
123 Slater St., 2nd Floor
Ottawa, Ontario
K1A 1B9

A copy of the application may be faxed to (613) 952-8576, however, the original must be sent by mail.

For further information, you may contact Evaluation and Authorization Division by phone at (613) 952-2219 or (613) 957-1063, by fax at (613) 952-8576 or by e-mail at exemption@hc-sc.gc.ca