Exemptions from provisions of the Controlled Drugs and Substances Act
Health Canada manages exemption requests under the Controlled Drugs and Substances Act (CDSA). An exemption may be granted to allow a controlled substance or precursor to be used for specific scientific or medical purposes, or when it is determined to be in the public interest.
On this page:
- About exemptions
- Compliance and enforcement
- Request an exemption
- Timelines for processing exemption requests
About exemptions
The CDSA is one of Canada's federal drug control laws. It provides the framework for the control of drugs and precursor chemicals that can result in harm when misused or diverted to an illegal market.
Under the CDSA, most activities with controlled substances and precursor chemicals are illegal, unless specifically allowed through:
- regulations or
- an exemption granted by the Minister of Health
An exemption is a formal document issued to a person or group. It authorizes specific activities with controlled substances or precursor chemicals that would otherwise be illegal. For example, a researcher can request an exemption to conduct studies with a controlled substance such as ketamine, buprenorphine, sodium pentobarbital, or other controlled substances. The exemption usually specifies the duration for which it is valid and includes terms and conditions for the types of activities that it authorizes.
Health Canada reviews each request for an exemption under the CDSA on a case-by-case basis. The department considers all relevant information, including:
- potential benefits (for example, whether the research will benefit the health of Canadians)
- potential risks or harms to the health and safety of Canadians (for example, certain substances, such as fentanyl, are very dangerous if misused)
- evidence that the controlled substance or precursor chemical is necessary for the activity
- safeguards for the use and storage of the controlled substance or precursor chemical to prevent theft or misuse (for example, limitations on who can handle the substance)
Note that applying to operate supervised consumption sites and services falls under a separate process. Please see supervised consumption sites and services for more information.
Class exemptions
Health Canada also issues class exemptions, which authorize groups of people to conduct specific activities with controlled substances or precursor chemicals. These exemptions could apply to people in a geographic area (for example, a provincial class exemption) or a profession (for example, pharmacists).
For more examples, refer to the list of class exemptions and related guidance.
Compliance and enforcement
Exemption holders must comply with the terms and conditions set out in the exemption. Health Canada can revoke an exemption at any time if the exemption holder is not in compliance with the terms and conditions of their exemption.
Health Canada monitors compliance through a number of mechanisms, including verifying that:
- record-keeping is complete
- losses and thefts of controlled substances and precursor chemicals are promptly reported to Health Canada
Health Canada inspectors may visit exemption holders at any point to verify compliance.
Learn more about compliance and enforcement actions.
Request an exemption
Complete the relevant form based on the purpose of the exemption you are requesting.
Scientific research involving in vitro or animal studies
Human clinical trials
All other exemption requests
- For non-routine requests that do not fall under the categories listed above, please contact the Exemptions Section at exemption@hc-sc.gc.ca.
- Detailed information for individuals, patients, health practitioners, researchers or health care professionals seeking to access psilocybin is available on the psilocybin and psilocin page.
Other situations
Methadone
- Exemptions are no longer required for practitioners to prescribe, administer, sell or provide methadone to their patients.
Timelines for processing exemption requests
We strive to assess requests in a timely fashion.
- For clinical studies, Health Canada aims to process exemption requests within 45 calendar days of receipt of all required documents.
- For scientific research, Health Canada aims to process exemption requests within 70 calendar days of receipt of all required documents.
- For non-routine exemptions, there is no set time period for receiving decisions. The review time varies depending on the complexity and completeness of the request.
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