Application form for an exemption to use a controlled substance for clinical studies

A qualified investigator (QI) (practitioners affiliated to universities and/or private industry) requiring a controlled substance for research purposes which include administration to humans in a clinical trial must receive an exemption under subsection 56(1) of the Controlled Drugs and Substances Act (CDSA). Thus, once issued, an exemption will authorize the qualified investigator (practitioner) to purchase (if applicable), possess and administer specific controlled substances in specific quantities for a specific clinical study protocol.  Members of the research staff who are working on the same research project under the direction and control of the practitioner are also exempted within the same scope and for the same purpose as the practitioner.  Please note that you are responsible for any portion of the controlled substance that is administered by or in the possession of by these individuals.

Exemptions are valid for 2 years from the issuance date. You may apply for an extension if required.

Before an exemption can be issued, you must first submit a Clinical Trial Application (CTA) to the Office of Clinical Trials of the Therapeutic Products Directorate. If they process the application favorably, a no objection letter (NOL) will be issued. More information can be found within The Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications.

Then, you may apply for an exemption. With the completed application, a copy of the Protocol and the NOL must be provided.

The average processing time for an exemption (once all information required is provided) is 45 calendar days.

Please complete the application form for an exemption to use a controlled substance for clinical studies.

Completed applications forms can be submitted to exemption@hc-sc.gc.ca or mailed to address below:

Exemptions Division
Office of Controlled Substances
Health Canada
161 Goldenrod Drwy
AL0300B
Ottawa ON K1A 0K9

Please email exemption@hc-sc.gc.ca with any questions or concerns.