Improving the Licensing of Production of Cannabis for Medical Purposes
Health Canada is introducing several improvements that aim to streamline the licensing of medical cannabis producers and enable increased production of cannabis.
Licensed producers and applicants will need to continue to meet all of the requirements under the Access to Cannabis for Medical Purposes Regulations, including the security and inventory control measures that help prevent diversion, and the Good Production Practices that help to provide individuals with access to quality-controlled cannabis for medical purposes.
As announced previously, Health Canada has begun conducting random testing of cannabis products produced by licensed producers to provide added assurance to Canadians that they are receiving safe, quality-controlled product.
What is a licensed producer?
A licensed producer is the holder of a producer’s licence that is issued by Health Canada under the Access to Cannabis for Medical Purposes Regulations to produce quality-controlled cannabis under secure and sanitary conditions. They can be authorized to produce and sell dried and fresh cannabis, seeds and plants, and cannabis oil. As of May 24, 2017, there are 44 licensed producers of cannabis for medical purposes. Over the past four years, licensed producers have established a strong record of compliance and are inspected regularly by Health Canada.
Licensed producers are authorized to sell to registered clients who have been authorized by their healthcare practitioner to use cannabis for medical purposes. Products are delivered to clients securely through the mail or by courier. More than 153,000 individuals are registered to purchase cannabis from licensed producers, while more than 4,000 individuals are registered with Health Canada to produce a limited amount of cannabis for their own medical purposes. On average, the number of registered clients has been growing by 10% a month. Sales of dried cannabis have been growing by 6% a month, and sales of cannabis oil have increased by 16% a month.
What is the current process to become a licensed producer?
All applications to become a licensed producer undergo a strict and thorough review. Applications are assessed on a case-by-case basis. All key personnel must pass a stringent security clearance process. In addition, each application must demonstrate how the security and inventory control measures and Good Production Practices at the facility meet all the regulatory requirements. This compliance is verified by Health Canada inspectors.
How will the licensing approach change?
Health Canada has drawn on nearly four years of experience administering the medical cannabis regime to identify what works well, and what can be improved. The changes that are being put in place are measures to streamline licensing and enable increased production of cannabis for medical purposes. These measures will help ensure that Health Canada’s approach to licensing and oversight continues to be aligned with the regulations, the existing evidence of risks to public health and safety, and its approach to other regulated sectors.
Effective immediately, Health Canada is implementing the following measures:
- Increasing the Department’s capacity to review and process applications
- Health Canada is allocating more resources to streamline the processing of applications to produce cannabis for medical purposes. The majority of these additional resources will focus on applications at the review stage, during which Health Canada undertakes a detailed review of all aspects of the application and assesses its compliance with the requirements of the regulations. There are currently 187 applications at the review stage. Additional resources will also be applied to applications at the intake and screening stage.
- In the past few weeks, Health Canada has dedicated additional resources to accelerate the processing of applications from individuals who are authorized by their healthcare practitioner to produce a limited amount of cannabis for their own medical use.
- Undertaking some stages of the review of the application concurrently;
- The detailed review stage of processing applications will now happen at the same time as the personnel security screening process. Historically, the review stage did not begin until the security screening of key personnel is complete, which can lengthen the time to process the application.
- Permitting licensed producers to manage production on the basis of their vault capacity;
- Licensed producers will be permitted to increase cannabis production within their existing facility to the maximum they are authorized to store, based on the capacity and security level of their vault(s) or safe(s). This will allow licensed producers to better manage production as necessary to meet demand.
- In addition, licensed producers will be able to store low-value cannabis waste products (e.g., leaves) in a secure area and will no longer need to keep these products in a secure vault or safe, thereby creating more room for storage of finished cannabis products and enabling increased production.
- Authorizing longer validity periods for licences and security clearances in accordance with the regulations
- New licences that are issued, and existing licences that are renewed for licensed producers with a good compliance record, may now be valid for the full three years allowed in the regulations. New or renewed security clearances for key personnel at licensed production facilities may also be valid for up to five years in accordance with regulations, subject to Health Canada receiving new information that could result in a security clearance being suspended.
- Streamlining the review and approval of applications to modify or expand a production facility for licensed producers with a record of good compliance with the ACMPR;
- Where a licensed producer has a good compliance record and the proposed modification or expansion is straightforward, materially similar to an existing room or facility, and falls within an existing security perimeter (e.g., fence), applications for a production site modification or expansion may be approved following a successful application review. The physical inspection of the site modification or expansion would then occur during the regular facility inspection rather than before approval.
Health Canada will continue to inspect all facilities before cultivation begins and before a licence to sell products to the public is issued. Henceforth, Health Canada will schedule this first inspection after it has determined an application meets the regulatory requirements and it has issued the licence to cultivate and once the producer is ready to initiate production in its facility. This approach will help provide successful applicants with a decision on their application as soon as possible while ensuring that all facilities are inspected as cultivation begins.
Licensed producers and applicants must continue to meet all of the requirements under the Access to Cannabis for Medical Purposes Regulations. These include security and inventory control measures that help prevent diversion, and the Good Production Practices that help provide individuals with access to quality-controlled cannabis for medical purposes. Since licensed production began in June 2013, licensed producers have established a solid record of compliance with the regulatory requirements and Health Canada will continue to ensure compliance through regular inspections.