Research Licence
Confirm the need for a research licence and determine appropriate licence model
Is a licence required?
Before applying for a licence, first determine whether a research licence is the appropriate licence for your proposed activities. Clinical trials, plant genetics, the development of cannabis products, in vivo and in vitro investigations, product development, and educational initiatives are just a few examples of research efforts. You may already be permitted to perform research and development activities under the provisions of another licence you or your organisation possesses under the Cannabis Act. For clarification, check the terms of your current licence or get in touch with Health Canada.
If you wish to carry out analytical testing activities on cannabis (including cannabis products) as a service, you must apply for an analytical testing licence. If you only conduct analytical testing in support of your own research activities, only a research licence is required.
Important: As per the Cannabis Act, cannabis (including hemp) means:
- Any part of a cannabis plant, including the phytocannabinoids produced by, or found in, such a plant, regardless of whether that part has been processed or not, other than a part of the plant referred to in Schedule 2;
- Any substance or mixture of substances that contains or has on it any part of such a plant; or
- Any substance that is identical to any phytocannabinoid produced by, or found in, such a plant, regardless of how the substance was obtained.
The term cannabis DOES NOT include:
- A non-viable seed of a cannabis plant;
- A mature stalk, without any leaf, flower, seed or branch, of such a plant;
- Fibre derived from a mature stalk; or
- The root or any part of the root of such a plant.
Important: If the research being proposed involves the cultivation of industrial hemp plants only (i.e. cannabis plants containing less than 0.3% THC), you may only require an industrial hemp licence to conduct your research. For more information, please see the Industrial Hemp Regulationsand Industrial Hemp Licensing Application Guide.
Important: Research licences cannot be applied for through an amendment to an existing cannabis licence, nor can a new cannabis licence (e.g., for cultivation or processing) be added to a research licence through an amendment. Licence Holders wishing to apply for these licences must submit a new licence application.
The term cannabis DOES NOT include:
- A non-viable seed of a cannabis plant;
- A mature stalk, without any leaf, flower, seed or branch, of such a plant;
- Fibre derived from a mature stalk; or
- The root or any part of the root of such a plant.
Important: If the research being proposed involves the cultivation of industrial hemp plants only (i.e. cannabis plants containing less than 0.3% THC), you may only require an industrial hemp licence to conduct your research. For more information, please see the Industrial Hemp Regulationsand Industrial Hemp Licensing Application Guide.
Important: Research licences cannot be applied for through an amendment to an existing cannabis licence, nor can a new cannabis licence (e.g., for cultivation or processing) be added to a research licence through an amendment. Licence Holders wishing to apply for these licences must submit a new licence application.
Determine licence model
To allow for greater flexibility depending on your organization and the type of research that you wish to conduct, there are three models of research licences that are available:
- One project, one site: One research licence covering one research project, generally with a single research protocol and activities taking place at only one site. If you are a research group that has more than one project, but all under the purview of a single principle investigator in one research area, this model would still apply.
- One project, multiple sites: One research licence covering one research project, but with research activities taking place at multiple sites (e.g., a clinical trial at numerous hospitals).
- One institution, one site: One research licence 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).
Determine what model best suits your proposed research activities prior to starting your application, as the licence model selected will determine the various information requirements as you develop your application.
Health Canada is pleased to announce that the Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages and the Order Amending Schedule 3 to the Cannabis Act came into force on December 2, 2022 and will be published inthe Canada Gazette, Part II on December 21, 2022.
Facilitation of non-therapeutic research on cannabis:
- Non-therapeutic research on cannabis involving human participants no longer needs to meet the requirements for clinical trials under the Food and Drug Regulations (FDR).
- It is now possible to conduct this research solely under the Cannabis Regulations. These amendments allow researchers to investigate cannabis and its effects from a non-therapeutic perspective and allow more research for cannabis product development.
- The Cannabis Act and its regulations include appropriate health and safety controls to protect research participants.
- Clinical trials with cannabis that are currently underway are not impacted by these changes. The FDR and relevant sections of the Cannabis Regulations continue to regulate such research (e.g. requirements for a research licence, cannabis production and record retention).
- Existing research licence holders conducting research with human participants have a 24-month transition period to submit new applications, or in some cases, amend their existing licenses.