Service Standards for Issuance, Renewal and Amendments to Cannabis Research Licences

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.

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.

Health Canada also reviews requests by licence holders to amend their research licence.

The grounds for refusal to issue, renew, or amend 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, its renewal, or to make amendments.

Service Standards:

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 institutional licences for the issuance of a regulatory decision on an application for a new cannabis research licence.

Health Canada commits to a non-binding administrative service standard of 42 business days for single-protocol projects, and 60 business days for multi-protocol projects or institutional licences for the issuance of a regulatory decision on a renewal of a cannabis research licence.

Health Canada also commits to a non-binding administrative service standard of 30 business days for the issuance of a regulatory decision on an application for an amendment to a cannabis research licence, for both single-protocol and multi-protocol projects (and institutional licences).

Service standards start from the date the application is received by the department to the date a decision is issued to the applicant or licence holder. The time the application is with the applicant or licence holder for additional required information does not count towards the service standard.

Performance Target:

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

Performance results in fiscal year 2020 to 2021:

In 2020-2021:

• 36% of applications for new single-protocol cannabis research licences were processed within the 42 business day service standard.
• 40% of applications for new multi-protocol or institutional cannabis research licences were processed within the 180 business day service standard.
• 69% of renewal applications for single-protocol cannabis research licences were processed within the 42 business day service standard. 100% of renewal applications for multi-protocol or institutional cannabis research licences were processed within the 60 business day service standard.
• 61% of amendment applications for a cannabis research licence were processed within the 30 business day service standard.

Departmental Contact:

Please contact the Cannabis Licensing and Medical Access Directorate to make any general inquiries or comments:
Cannabis Licensing and Medical Access Directorate
Controlled Substances and Cannabis Branch
Health Canada
Ottawa, Ontario
K1A 0K9
E-mail: licensing-cannabis-licences@hc-sc.gc.ca