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How to Get an NTRC Licence for Sensory Research
Health Canada held a webinar on September 24, 2024, announcing that sensory research study licences issued before December 2, 2022, will need to transition to a Non-Therapeutic Research with Cannabis (NTRC) licence before December 2, 2024. It’s crucial to submit your application to transition to the new NTRC licence as soon as possible since Health Canada’s review and approval process can take 42 business days or more.
Businesses that do not receive approval by December 2, 2024, will no longer be authorized to conduct any cannabis activities related to the licence until approval is received. To avoid disruption to your operations, now is the time to begin preparing the new NTRC application. Here’s everything you need to know about the transition to an NTRC licence.
What is the NTRC Licence?
The Non-Therapeutic Research with Cannabis (NTRC) licence allows for controlled studies on cannabis and cannabis products to reveal their effects, without any investigation into potential health benefits. To conduct these studies, the licence holder is authorized to administer or provide cannabis to individuals participating in a study and evaluate the effects.
The primary goals the NTRC licence aims to achieve are:
- Increase understanding of cannabis and its non-therapeutic effects.
- Provide information to support public health, safety, education, and policy decisions.
- Advance research and development of cannabis products.
How Does the NTRC Licence Work?
The NTRC licence framework is based on the amount of risk associated with the studies that a business wants to conduct. As a result, anyone seeking an NTRC licence to conduct sensory or non-therapeutic cannabis research must first determine the risk category their study falls into. There are three categories:
Category 1: Lowest risk
Category 2: Medium risk
Category 3: Highest risk
You can only choose one risk category when applying for a research licence, and if the studies you plan to conduct fit into multiple categories, you must select the highest applicable category.
Health Canada encourages businesses to consider these questions before applying:
- Are your participants taking stable medications, using cannabis occasionally, or do they have a history of cannabis use? If yes to any, your study could be Category 3.
- Is the cannabis dose, type, or method different from what participants are used to? If yes to any, your study is Category 3.
- Are you using invasive methods (e.g., biopsies, blood draws) or combining cannabis with substances like alcohol or nicotine? If yes, your study is Category 3.
- Are you using non-invasive methods like saliva tests, driving simulators, or evaluating the psychological effects of cannabis? If yes, your study may be Category 2.
If none of the above factors apply, your study falls under Category 1.
How Will NTRC Impact Sensory Studies?
All Sensory Study Licence holders will need to evaluate their studies and apply for the correct category of NTRC licence before December 2, 2024. Those who do not get an NTRC licence by the deadline will not be eligible to continue their studies.
Businesses currently holding a Sensory Study Licence should only be conducting studies that fall into the Category 1 (lowest risk) framework. Some adjustments will need to be made to those studies to meet the requirements of the NTRC licence. These include:
- Additional research study protocol information.
- Additional inclusion/exclusion criteria for study participants.
- Information on the range of product types studied.
- Requirements for adverse event record-keeping.
- Additional plans for ensuring participant safety.
- Additional information regarding informed consent, data handling, and privacy.
To continue engaging in sensory studies, testing facilities will need to obtain an NTRC licence by completing a new application and meeting all licensing and post-licensing requirements.
How to Apply for an NTRC Licence
- The NTRC licence falls under Health Canada’s research licence category. As a result, the application process has unique requirements that must be met to get a licence. Here are the application requirements for a Category 1 NTRC licence:
- Copy of government-issued photo ID for individuals listed on the application
- Corporate organizational chart
- For corporations: Copy of certificate of incorporation, amalgamation, or amendment
- For cooperatives/partnerships: Copy of business name registration or partnership agreements
- For corporations: Copy of certificate of incorporation, amalgamation, or amendment
- Site details
- Application form
- Cannabis information form (Category 1 applicants can submit this form after receiving the licence)
- Abridged protocol detailing study objectives, design, participant info, procedure details, and more. Find more details from Health Canada here.
- Physical Security Requirements including:
- Site plan
- Physical security description
- Physical security measures framework (for institutions)
- Institution-wide site attestation
- Identified Individuals:
- Licence holder’s ID (if an individual)
- Responsible person’s ID
- Alternate responsible person’s ID (if applicable)
- Site plan
- Record Keeping:
- Record keeping attestation
- Institution-wide responsible person attestation
- Record keeping attestation
Work with CannDelta for NTRC Licensing
While these new requirements may pose some challenges to existing Sensory Licence holders, CannDelta can demystify this transition and advise you on how best to maintain your existing workflows with minimal interference.
Our team has developed an amendment package for licence holders like yourselves that includes completed versions of all required documentation for the transition and the associated advisory work. Additionally, we have included an updated SOP package for your employees to ensure compliance with the new requirements.
If you need an NTRC licence to continue your operation, or you want to start a new Category 1 study, let us know by filling out the form below!
