Application Process: Becoming a Licensed Producer of Cannabis for Medical Purposes
For more information on the recent licensing process update, please see the Information Bulletin entitled “Improving the Licensing of Production of Cannabis for Medical Purposes”.
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.
To obtain an Application Form, please e-mail: ACMPR-RACFM@hc-sc.gc.ca.
Please note that you must submit a completed Security Clearance Application Form and Security Clearance Fingerprint Third Party Consent to Release Personal Information Form with your completed Application.
Effective May 25, 2017, the application process for becoming a licensed producer of cannabis for medical purposes is as follows:
Note: An applicant may be sent back to the Intake and Initial Screening stage if new information affecting the application is received by Health Canada at the Detailed Review and Security Clearance stage. An application can be refused at any stage in the process, before a licence is issued.
An applicant may be sent back to the Intake and Initial Screening stage if new information affecting the application is received by Health Canada at the Detailed Review and Security Clearance stage. An application can be refused at any stage in the process, before a licence is issued.
As of May 25, 2017
- 1665 applications received
- 265 have been refused
- 428 applications are in progress
- 69 have been withdrawn
- 858 were incomplete and have been returned
Licences are only issued once it has been determined that all information submitted demonstrates compliance with the Access to Cannabis for Medical Purposes Regulations (ACMPR) and the facility has been built. Each application undergoes a detailed assessment and review, including in-depth security checks undertaken by the RCMP.
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.
Intake and Initial Screening
When an application is received, it undergoes an assessment for completeness.If an application appears to be complete, it will be assigned an application number. The application number means that the application has completed the assessment. Applicants should reference their application number in all correspondence with Health Canada.
The Initial Screening includes an assessment of:
- the proposed business plan;
- the Security Clearance Application Form and
- record-keeping methods pertaining to security, Good Production Practices, inventory, and destruction methods.
If an application is not complete, depending on the information that is missing, applicants may be contacted by Health Canada to obtain the missing information or the application may be returned to the applicant.
Health Canada will also verify that applicants have provided notices to the senior officials with the local government where their proposed site is located.
Detailed Review and Initiation of Security Clearance Process
All information submitted to Health Canada, and any other relevant information, is reviewed to:
- complete the assessment of the application to ensure that it meets 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
- establish that there are no other grounds for refusing the application.
An application will be thoroughly reviewed to ensure that the level of detail included in the application is sufficient to assess the requirements of the ACMPR and validate the information provided. Consideration is also given to the proposed security measures including those required by Subdivision C of the ACMPR and the description of the storage area for cannabis as required by the Security Directive; the credentials of the proposed quality assurance person to meet the good production requirements outlined in Subdivision D of the ACMPR and the details listed in the quality assurance report relating to premises, equipment and sanitation program. Physical security plans will be reviewed and assessed in detail at this stage.
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 environmental legislation (e.g. waste management).
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.
While the application is in the Detailed Review stage, 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.
Issuance of Licence to Produce
Once Health Canada confirms that the requirements of the ACMPR have been met, and the application successfully completes the Detailed Review and Security Clearance stage, a licence to produce will be issued.
As part of the Terms and Conditions on their licence, a licensed producer is required to notify Health Canada as cultivation begins. Once notified, Health Canada will schedule an initial inspection to verify that the licensed producer is meeting the requirements of the ACMPR including, but not limited to, the physical security requirements for the site, record-keeping practices and Good Production Practices (GPP) and to confirm that the activities being conducted by the licensed producer correspond to those indicated on their licence.
Before being authorized for the activity of sale, the licensed producer must undergo a Pre-Sale Inspection by Health Canada to verify that they are in full compliance with all requirements of the ACMPR, with a focus on good production practices.
Pre-Sales Inspection (prior to issuance of sales licence)
If a licensed producer wishes to add the activity of sale to their existing licence, an amendment application must be submitted to the Office of Medical Cannabis. Health Canada will then schedule an inspection to verify that the licensed producer is meeting the requirements of the ACMPR including, but not limited to, Good Production Practices, packaging, labelling, shipping, and record keeping prior to allowing the sale or provision of product.
Issuance of Licence to Sell
To complete the assessment of the requirements of the ACMPR and establish that adding the activity of sale of cannabis products is not likely to create a risk to public health, safety or security, and to confirm that there are no other grounds for refusing the amendment application, the following information is reviewed:
- results of the pre-sale inspection;
- information submitted in the amendment application to add the activity of sale to the licence; and
- any other relevant information.
When the review is completed, an amended licence, including the activity of sale, is issued to the licensed producer. The licensed producer may now begin supplying cannabis products to registered clients, other licensed producers and/or other parties named in subsection 22(2) of the ACMPR, depending on the activities licensed. Separate licences may be issued for dried marijuana, plants and/or cannabis oil.
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. 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 location/address: Applicants at the Detailed Review stage must submit a new application in its entirety for assessment; the previous application will be closed. The new application will be returned to the Detailed Review and 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.
The Office of Medical Cannabis 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 may 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 be grounds for refusal.
For more information, please visit the Additional Information for Licensed Producers web page.
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