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Drugs and Health Products

Application Process: Becoming a Licensed Producer

All applications to become a licensed producer of cannabis for medical purposes undergo a strict and thorough review as outlined below.

All aspects of an application are subject to ongoing review based on a variety of factors, including but not limited to receipt of updated information, new developments, the result of subsequent reviews of the application, etc. Applicants should not assume the adequacy of any part of their application based on their stage in the application process.

There are many stages to the application process for becoming a licensed producer of cannabis for medical purposes:

  1. Applications received
  2. Preliminary screening
  3. Enhanced screening
  4. Initiation of security clearance process
  5. Review
  6. Pre-licence inspection
  7. Licensing

Note: An applicant may be sent back to a stage previously cleared if new information affecting the application is received by Health Canada. Also, an application can be refused at any stage of the process.

As of August 1, 2016

  • 1561 applications received
  • 253 have been refused
  • 419 applications are in progress
  • 54 have been withdrawn
  • 801 were incomplete and have been returned

Licences are only issued once all regulatory requirements are met. Each application undergoes a detailed assessment, including in-depth security checks led by the RCMP and site inspections.

Health Canada conducts compliance and monitoring activities of regulated parties to ensure compliance with the various regulations to the Controlled Drugs and Substances Act (CDSA). These activities include education, complaint investigations and inspecting licensed sites, or sites applying to be licensed to conduct regulated activities.

Below is additional information on each stage of the application process.

Preliminary Screening

When an application is received, it undergoes a preliminary screening for completeness. If an application is not complete, it will be returned. If an application appears to be complete, it will be assigned an application number. The application number means that the application has completed the preliminary screening. Applicants should reference their application number in all correspondence with Health Canada.

Enhanced Screening

Once an application has been assigned an application number, it will be reviewed to ensure that the level of detail included in the application is sufficient to assess the requirements of the regulations. Initial consideration is also given to the location of the proposed site; likely risks to public health, safety and security; the proposed security measures; and the credentials of the proposed quality assurance person to meet the good production requirements outlined in Subdivision D of the Access to Cannabis for Medical Purposes Regulations (ACMPR). On a case-by-case basis Health Canada may also request and/or review other information that is relevant to the application.

Health Canada will also verify that applicants have provided notice to the senior official with the local government where their proposed site is located.

Applicants are reminded that licensed producers are required to comply with all applicable provincial/territorial and municipal laws, including zoning restrictions, fire and electrical safety, and waste management.

Security Clearance

Once the screening of an application is complete, the security clearance forms for key personnel will be sent for processing.

When applying for a licence to produce under the ACMPR, a Security Clearance Application form must be submitted for the following individuals:

  • the proposed senior person in charge;
  • the proposed responsible person in charge;
  • the proposed alternate responsible person(s) in charge (if applicable);
  • if a producer's licence is issued to an individual, that individual; and,
  • if a producer's licence is issued to a corporation, each officer and director of the corporation.

For more information on the security screening process please visit the Additional Information for Licensed Producers web page.

Review

An application will be thoroughly reviewed to validate the information provided. Given the extensive review process, applicants should anticipate communicating with the Office of Medical Cannabis multiple times to provide clarifications on the application. Health Canada may also request additional information from the applicant as required.

Physical security plans will be reviewed and assessed in detail at this stage. Please note that applicants must meet a minimum of a level 7 (as defined in the Directive on Physical Security Requirements for Controlled Substances (Licensed Dealers Security Requirements for the Storage Of Controlled Substances) to be considered for a licence. Physical security must comply with the Directive.

When Health Canada believes an application is ready for a pre-licence inspection, Health Canada will contact the applicant and identify the information that needs to be confirmed before a pre-licence inspection can be scheduled. This includes, but may not be limited to confirming how the applicant has indicated in their application that they would comply with Part 1, Division 1, Subdivision C (Security Measures) of the ACMPR.

Pre-licence inspection

Section 21 of the ACMPR (Inspection of Site) allows for the possibility of a pre-licence inspection. This includes, but is not limited to: Security Measures, Good Production Practices, Packaging, Labelling and Shipping, Registration, and Record Keeping. For information on preparing for inspections, please reference the information bulletin titled, "Inspections - What to Expect".

Licensing

The results of the pre-licence inspection are reviewed with all the information submitted to Health Canada, and any other relevant information, to complete the assessment of the application in keeping with the requirements of the Regulations, establish that the issuance of the licence is not likely to create risks to public health, safety or security, including the risk of cannabis being diverted to an illicit market or use, and there are no other grounds for refusing the application.

The process for the initial issuance of a licence includes limits on licensed activities and a maximum limit on the total amount of cannabis authorized for production. For more information on the issuance of licences, please see the information bulletin titled, "Issuance of Licences to Produce Cannabis for Medical Purposes."

Changes to Applications

Any changes to your application will result in additional processing time.

Changes to personnel (adding new personnel or replacing individuals): Applications will be returned to the security clearance stage for processing. All individuals must be processed before the application will advance to the review stage.

Changes to Quality Assurance Person or Program, record keeping method, security proposal, and /or floorplans: Application will be returned to the review stage for assessment.

Changes to your site: Applicants must submit a new application in its entirety for assessment; the previous application will be closed (however it may maintain the original file number). The new application will be returned to the security clearance stage. This change will have a significant impact on processing time. Alternatively, the applicant may withdraw the current application and submit the new site application (in this case a new file number will be assigned).

The OMC will assess the extent and impact of changes to the application in process and will determine if a new application file number will be assigned to facilitate the application review administration.

Considerations for Applicants

Application processing times are variable and depend on a number of factors, including:

  • the completeness of the application and the thoroughness of the information provided;
  • the timeliness of applicant responses to requests for additional information;
  • the readiness of the applicant to move through the process;
  • the complexity of the application; and,
  • whether the application poses any risks, including a risk to public health, safety or security.

The timeline for security screening of key personnel can also vary depending on the complexity of the applicant's file.

The entire application process can take more than a year to complete.

It is the responsibility of the applicant to ensure that the information provided in their application is detailed and accurate and clearly demonstrates that they are compliant with all the requirements of the ACMPR. Insufficient or inaccurate information may give rise to grounds for refusal.

For more information, please visit the Additional Information for Licensed Producers web page.