Service Standard for Issuance and Renewal of a Cannabis Research Licence

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Cannabis Act and the Cannabis Regulations should be relied upon for specific requirements, including if there are discrepancies between this page and the Cannabis Act and its Regulations.

Service Description:

Health Canada posts service standards and performance information for services with over 100 regulatory authorizations, such as permits or licences, issued each year (high-volume regulatory transactions).

The Cannabis Act and its Regulations provide a legal framework for the possession, production, distribution and sale of cannabis in Canada.

Under this framework, a person is required to obtain a licence issued by Health Canada in order to conduct research activities with cannabis, including administering cannabis to research subjects in a clinical trial. In addition, licence holders are responsible for compliance with the Cannabis Act and its regulations, and with other applicable federal, provincial and territorial legislation and municipal by-laws.

Beginning October 17, 2018, all research licences were issued pursuant to the Cannabis Act and the Cannabis Regulations. This updated the previous paper-based application process into an online electronic application process via the Cannabis Tracking and Licensing System (CTLS), which is the primary means through which applicants may apply for a research licence from Health Canada.

Refer to the following legislation and guidance document to guide you with the application process:

After an application is submitted in the CTLS, it is processed through the following steps:

  1. Screening: every section of the application and all attached documents are assessed for completeness and suitability.
  2. Review: once the application has passed the screening stage, a complete review is undertaken to verify that the information provided in support of the application satisfies all of the regulatory requirements.
  3. Issuance or refusal of licence: once all information in the application has been reviewed, a regulatory decision is made to either issue or refuse to issue a licence. If the decision is to issue a licence, a hard copy of the licence is mailed to the applicant at the mailing address in the application.

The grounds for refusal to issue or renew a licence are found under subsection 62(7) of the Cannabis Act.

There is currently no fee associated with the application for a new research licence or its renewal.

Service Standard:

Health Canada commits to a non-binding administrative service standard of 42 business days for single-protocol projects, and 180 business days for multiple-protocol projects or large-scale facilities for the issuance of a regulatory decision on an application for a new Cannabis Research Licence. Health Canada also commits to a non-binding administrative service standard of 60 business days for the renewal of a Cannabis Research Licence. Service standards are applied from the date the application is received by the department to the date a decision is issued to the applicant. This service standard does not apply to amendments.

Performance Target:

The target to meet each of these standards is set at 80%.

Performance result for fiscal year 2019 to 2020:

In 2019-2020, 12% of applications for new single protocol research licences were processed within the 42 day service standard. Of the new multi-protocol research license applications, 66% were processed within the 180 business day service standard. For research licence renewal applications, these applications were processed 42% within the 60 day service standard.

Departmental Contact:

Please contact the Specialized Licensing Unit to make any general inquiries or comments:

Specialized Licensing Unit
Cannabis Licensing and Medical Access Directorate
Controlled Substances and Cannabis Branch
Health Canada
AL 0300A
Email: hc.sp-licensing-cannabis-licences-sp.sc@canada.ca

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