Cannabis Research License - What Is It? How To Apply For It?

What Is A Cannabis Research License?

The Canadian government has granted researchers permission to study the medical properties of marijuana. This means that scientists will soon be able to conduct clinical trials in order to determine whether cannabis could be used to treat various diseases.  In Canada, there are two different kinds of licenses available for researchers who wish to study the effects of cannabis on human subjects. One type of license allows researchers to use cannabis for scientific purposes without having to obtain approval from Health Canada. The other type of license requires researchers to apply for approval from Health Canada before conducting any studies involving cannabis.

 

Research License Overview

What Can You Do With A Cannabis Research License?

There are three models of cannabis research licenses that are currently available:

  1. One project, one site: One research license covering one research project, generally with a single research protocol and activities taking place at only one site.
  2. One project, multiple sites: One research license covering one research project, but with research activities taking place at multiple sites (e.g., a clinical trial at numerous hospitals).
  3. One institution, one site: One research license covering multiple research projects taking place at one institution (e.g., numerous researchers or projects at a single university campus or research hospital; or a large research group performing multiple projects, such as a contract research organization).

What Isn’t Covered Under A Cannabis Research License?

Those who hold a Research License are allowed to grow, possess, sell and distribute cannabis – but only within the guidelines that the license terms provide for (listed above). A Research License does not authorize the holder to give the general public any kind of access to the cannabis, or cannabis materials, that they grow and/or work with.

How Do I Know If I Qualify for a Cannabis Research License?

There are three main criteria that determine whether an applicant qualifies for a cannabis research license. First, applicants must be Canadian citizens or permanent residents. Second, applicants must be registered with Health Canada as a researcher. Third, applicants must have completed at least one year of postgraduate training in a relevant field.

What's Next After my Cannabis Research License Approval?

Once an applicant receives approval, they must register with the government as a researcher. This involves filling out forms and submitting them to the Ministry of Health. If the ministry approves the registration, the applicant will then be able to apply for a cannabis research license.

How Do I Apply For the Cannabis Research License?

An applicant must first fill out an online form at the Ministry of Health website. They should also submit a copy of their university degree certificate along with two letters of recommendation. Applicants must also provide evidence that they have completed a minimum of three years of postgraduate study.

Cannabis Research License Requirements

  • The holder of a Research License must retain the services of one individual as the Responsible Person, who has the authority to bind the holder. The Responsible Person will be accountable for the license holder’s activities and should have an adequate understanding of how the Cannabis Act and Regulations apply to the license holder.
  • The Research license holder should have a well written Research Protocol summarizing the proposed research to be conducted and the amount and type of cannabis required for the research (e.g., gram, kilogram, litre or number of plants or seeds, broken down by site, if applicable). The Research Proposal should also detail the tools and equipment to be used to perform the research with cannabis (e.g., analytical techniques, specify any in vivo or in vitro models to be used, etc.). It will need to be mentioned if human subjects are involved with the research, such as for clinical trials or palatability studies.
  • The license holder’s facility must have restrictive measures in place around their operational areas in order to safeguard against unauthorized access. It should be possible to demonstrate how the area’s construction, as well as any access controls on the exit and entry points, are able to achieve this goal. Access to all operational areas must be restricted to certain personnel only.

Applicants must submit a detailed proposal outlining how they plan to conduct their research. They also need to provide evidence that they meet the above requirements. Once the proposal has been accepted, applicants will receive a letter confirming their approval.

  • The holder of a Research License must retain the services of one individual as the Responsible Person, who has the authority to bind the holder. The Responsible Person will be accountable for the license holder’s activities and should have an adequate understanding of how the Cannabis Act and Regulations apply to the license holder.
  • The Research license holder should have a well written Research Protocol summarizing the proposed research to be conducted and the amount and type of cannabis required for the research (e.g., gram, kilogram, litre or number of plants or seeds, broken down by site, if applicable). The Research Proposal should also detail the tools and equipment to be used to perform the research with cannabis (e.g., analytical techniques, specify any in vivo or in vitro models to be used, etc.). It will need to be mentioned if human subjects are involved with the research, such as for clinical trials or palatability studies.
  • The license holder’s facility must have restrictive measures in place around their operational areas in order to safeguard against unauthorized access. It should be possible to demonstrate how the area’s construction, as well as any access controls on the exit and entry points, are able to achieve this goal. Access to all operational areas must be restricted to certain personnel only.

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