Service Standard for Issuance and Renewal of a Cannabis Research Licence

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:

• Cannabis Act
• Cannabis Regulations
• Cannabis Licence Application Guide: Research

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