Subsection 56(1) class exemption for participants enrolled in an authorized clinical trial involving at-home administration of MDMA or psilocybin

Pursuant to subsection 56(1) of the Controlled Drugs and Substances Act (CDSA), participants enrolled in an authorized clinical trial involving at-home administration of MDMA or psilocybin are exempted from the application of the following provisions of the CDSA when possessing, providing and transporting MDMA or psilocybin, subject to the terms and conditions below:

• Subsection 4(1) as it applies to the possession of the quantity and form of MDMA or psilocybin obtained from the qualified investigator of an authorized clinical trial in Canada; and
• Subsections 5(1) and 5(2) as they apply to the provision and transport for the purpose of returning to the qualified investigator any unused MDMA or psilocybin obtained pursuant to the authorized clinical trial.

Definitions

In respect of this exemption and unless otherwise defined below, the terms used in this exemption have the same meaning as those provided in the CDSA and its regulations.

• At-home administration means the consumption of MDMA or psilocybin by a participant, occurring outside of a hospital or clinical setting, typically within the participant's residence.
• Authorized clinical trial means a clinical trial that involves at-home administration and in respect of which the Minister has authorized activities with MDMA or psilocybin in a letter of authorization pursuant to subsection J.01.059(4) of the Food and Drug Regulations (FDR).
• Clinical trial has the same meaning as in section C.05.001 of the FDR.
• Qualified investigator has the same meaning as in section J.01.001 of the FDR.
• MDMA means 3,4-methylenedioxymethamphetamine and any salt thereof.
• Participant means a participant enrolled in an authorized clinical trial in Canada.
• Psilocybin means 3–[2–(dimethylamino)ethyl]–4–phosphoryloxyindole and any salt thereof.

Terms and Conditions

This exemption is applicable if the following conditions are met:

1. This exemption is only valid for a participant in an authorized clinical trial that involves at-home administration of MDMA or psilocybin.
2. Participants may only possess, provide and transport MDMA or psilocybin in the form and quantity authorized in the clinical trial.
3. The MDMA or psilocybin must be obtained from the qualified investigator of the authorized clinical trial, and be packaged and labelled according to the associated clinical trial requirements.
4. Participants may only provide or transport MDMA or psilocybin to the qualified investigator of the authorized clinical trial.
5. Any unused MDMA or psilocybin must be returned to the qualified investigator of the authorized clinical trial.
6. Participants must take any measures that are necessary to ensure the security of the MDMA or psilocybin in their possession against loss or theft.
7. Any loss or theft of the MDMA or psilocybin must be reported to the Compliance and Monitoring Division, Office of Controlled Substances (OCS) within 10 days of the discovery, by emailing ocs.reporting-rapporter.bsc@hc-sc.gc.ca.

Suspension without notice

This exemption may be suspended without prior notice if the Minister deems that such suspension is necessary to protect public health, safety or security.

Revocation

The Minister may revoke the exemption if they believe that it is no longer necessary or in the public interest.

Effective date

This exemption is effective as of September 20, 2025 and expires on the earliest of the following dates:

1. The date on which it is replaced by another exemption; or
2. The date on which it is revoked.

Signed for and on the behalf of the Minister of Health,

Aysha Mawani
Director General
Controlled Substances and Overdose Response Directorate
Health Canada