Service Standards for Screening and Review of New Applications and Amendments for Cultivation, Processing and Sale for Medical Purposes Licences under 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 various activities with cannabis. In addition, licence holders are responsible for compliance with the Cannabis Act, its regulations, and with other applicable federal, provincial and territorial legislation and municipal by-laws.

Refer to the following legislation and guidance to support the application process to become a licence holder under the Cannabis Act and its Regulations:

• Cannabis Act
• Cannabis Regulations
• Cannabis Licensing Application Guide

Applications are submitted through the electronic Cannabis Tracking and Licensing System (CTLS).

After a new licence application is submitted in the CTLS, it is processed through the following steps:

• Screening: the application, attached documents and, if required, the submitted site evidence package, are assessed for completeness, legibility and ability to be further assessed.
• Review: Once an application has passed the screening stage, and security clearance applications are being processed, the application will undergo a detailed review to verify that the requirements are met.
• 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.

Health Canada also reviews requests by licence holders to make changes or amendments to their licence through the CTLS, such as applications for:

• A "Site Plan Change Requiring Approval", such as adding a new building or storage area.
• A change to "Authorized Activities", such as adding the authority to sell a new class of cannabis products.
• A change to add or change a "Quality Assurance Person (QAP)" or alternate for a processing licence.

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

The relevant cost recovery fees associated with licence application screening under the Cannabis Act and its regulations were established by the Cannabis Fees Order. The Cannabis Fees Order Guide provides guidance on the interpretation of the Cannabis Fees Order and fee payment procedures.

Service Standards:

Health Canada commits to the following non-binding administrative service standards:

• 30 business days for screening new applications for cultivation, processing and sale for medical purposes licences, from the date payment is processed to the issuance of a decision on screening.
• 80 business days for the review of new applications for cultivation, processing and sale for medical purposes licences, from the date the application passes the screening stage to the issuance of a regulatory decision.
• 45 business days for the screening and review of an application for a “Site Plan Change Requiring Approval” for a cultivation, processing or sale for medical purposes licence, from the date the application is received to the issuance of a regulatory decision.
• 70 business days for the screening and review of an “Authorized Activities” change for a cultivation, processing, or sale for medical purposes licence, from the date the application is received to a referral for inspection.
• 30 business days for the screening and review of an application for a “Quality Assurance Person” change for a processing licence, from the date the application is received to the issuance of a regulatory decision.

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 for achieving these standards is set at 75%.

Performance results in fiscal year 2020-2021:

In 2020-2021:

• 86% of new licence applications were screened within the 30 business day service standard.
• 58% of new licence applications that have passed the screening stage were processed within the 80 business day service standard.
• 52%* of applications for a site plan change were processed within the 45 business day service standard.
• 100%* of applications to change authorized activities were processed within the 70 business day service standard.
• 97%* of applications to add or change a QAP or alternate were processed within the 30 business day service standard.

* Updates to CTLS were made in July 2020 to allow performance results to be tracked for amendments received by Health Canada as of that date. Results reflect regulatory decisions made from January 1 to March 31, 2021.  In the next fiscal year (2021-2022), results will cover the entire reporting cycle.

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