Health Canada ACMPR Application Process: 5 New Implemented Standards

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Health Canada ACMPR Application Process: 5 New Implemented Standards

Health Canada has been working on how to best improve the licensing process for applicants. New changes will be implemented to ensure that the licensing process continues to meet the regulations, including public health and safety, under the Access to Cannabis for Medical Purposes Regulations (ACMPR). In addition, these changes will allow increased production of cannabis for medical purposes. For this reason, it is essential to keep up to date with the latest information regarding Health Canada ACMPR application process for licensed producers.

Overview of Licensed Producers

Licensed producers meet the legal requirements under the ACMPR to produce, control and/or sell alternative forms of medical cannabis including dried and fresh cannabis, seeds and plants, and cannabis oil. They are authorized to sell medical cannabis to individuals or their designate who are authorized from their health practitioner to use cannabis for medical purposes.

Process to Become a Licensed Producer

Health Canada inspectors conduct a strict and thorough review with applicants who aim to become a licensed producer. Applicants must demonstrate how the security and inventory control and Good Production Practices at the facility meet the expected requirements under the ACMPR. All key personnel must also pass a strict security clearance process.

Implemented Standards

The following are 5 main standards that Health Canada has immediately put into action:

  1. Increasing the Department’s capacity to review and process applications.

Health Canada is providing more resources to consolidate the application process for licensed producers. The majority of these additional resources will focus on applications at the review stage, during which Health Canada reviews all aspects of the application and assesses its compliance with the requirements of the regulations. Additional resources will also be applied to applications at the intake and screening stage.

  1. Simultaneously undertaking some stages of the review of the application.

The detailed review stage of processing applications will now happen at the same time as the personnel security screening process. Previously, the review stage did not begin until the security screening of key personnel was complete, which would prolong the application process.

  1. 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.

  1. 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. However, any new information received by Health Canada could result in a security clearance being suspended.

  1. 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.

If a licensed producer has a good compliance record and the proposed modification or expansion is straightforward, applications for a production site modification or expansion may be approved following a successful application review. The same applies to an existing room or facility, and falls within an existing security perimeter (e.g., fence). 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. From now on, 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. Health Canada will continue to ensure compliance through regular inspections.

Reference https://www.canada.ca/en/health-canada/news/2017/05/improving_the_licensingofproductionofcannabisformedicalpurposes.html

Health Canada will continue to make improvements ensuring that existing and potential licensed producers meet Canada’s regulations and authorized individuals to use medical cannabis, receive quality-controlled cannabis.  Finding effective ways to improve the application process and access to cannabis not only provides better service to licensed producers but also helps to protect authorized consumers.

At PipeDreemz Inc. we will assist you at all stages of the application process and keep you up to date with the latest information about Health Canada’s requirements. Call us today at 1-833-226-2776 or send us an email info@pipedreemz.org to learn more.

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