91社区

Purpose

To ensure all departments working with cannabis and controlled substance do so in a safe and compliant manner that conforms to all rules and regulations set out by Health Canada and 91社区.

Scope

This is applicable to all cannabis and controlled substance research being conducted at 91社区 (excluding affiliated hospitals or institutions or to 91社区-affiliated research institutes and centers. These affiliated institutes are managed by their internal department compliance).

Approach/Protocol

The cannabis and controlled substance compliance program was implemented to maintain compliance with federal regulation and to help facilitate the application process for the required license. The program also aims to protect the University and its researchers from any noncompliance infractions that may otherwise not be known by the research community. For this reason, a mandatory training is required prior to acquiring, using, and disposing these products. This can be done while any permit acquisition requests are being processed.

Application Procedure

Internal Cannabis Research Application to Use Cannabis, Cannabis Materials or Their Derivatives in Research

*The turnaround time for processing an application is within 7 working days*

The generic application form to use cannabis in research at 91社区 is here.听

N.B. For research requiring the use or administration of cannabis to human participants, an amendment to the present cannabis research licence will be required from Health Canada. Please, reach out to the henry.ngu [at] mcgill.ca (Cannabis and Controlled Substances Officer )for assistance. The generic application captures and documents all required documents in compliance with the Cannabis Act.

The internal cannabis research application should be initiated and carried out by the Principal Investigator (PI) or by someone designated by them. The completed application Form and all other associated documentation is then to be forwarded to the EHS for its review and approbation. Any requests for modifications must be submitted through an amendment/modification process by completing the appropriate form. (to be established).

Examples of these modifications may include; - Changes to personnel - Permit extensions - Modifications in physical security framework, etc.,

Controlled Substances, the generic application form can be downloaded here: Scientific Exemption Application Form EN-v1

1. APPLICATION FOR A CONTROLLED SUBSTANCE EXEMPTION

1.1. A researcher requiring a controlled substance for research purposes at the University must, whenever necessary, such as in the context of sponsored research, notify OSR through the OSR Checklist, and must always contact and consult EHS to apply for, obtain, maintain and renew a Controlled Substance Exemption. The application form for a CONTROLLED SUBSTANCE EXEMPTION is available on the EHS website. Cannabis and Controlled Substance Compliance Program (CCSCP)

1.2. There are 6 application types:

• i. New exemption
• ii. Extension of valid exemption (no additional quantities)
• iii. Extension of valid exemption (additional quantities)
• iv. Amendment of a valid exemption
• v. Cancellation of a valid exemption
• vi. Transfer of controlled substances from one researcher to another within an institution

In completing the application form, the researcher will be asked to provide, among other information:

License number issued by provincial licensing body (if applicable)

Project or Study Description

Details of Administration

The current year鈥檚 approval of the protocol from the local Animal Care Committee (if applicable)

Supplier of the Controlled Substances

Description of Storage and Security

Researchers are advised to henry.ngu [at] mcgill.ca (contact EHS) with inquiries or for any assistance in completing this form.

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1.3. Once completed, EHS must submit the application form to Health Canada on behalf of the researcher.

1.4. Upon receipt of approval of the researcher鈥檚 exemption application, EHS must inform the researcher, copying OSR, in the context of sponsored research, and other interested parties as the case may be.

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In addition, EHS must: - provide the appropriate training and orientation to the researcher and, at the request of the researcher, to individuals participating in the same project, under the researcher鈥檚 direction and control, including but not limited to colleagues, assistants and technicians; and - create or update the researcher鈥檚 user profiles on MyLab and 91社区 Market Place (MMP).