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Kalpna Mistry

Kalpna Mistry

Health Canada’s Operational Changes to Cannabis Program Requirements

On May 12, 2020, Health Canada issued an email notice to federal cannabis licence holders announcing several operational changes being made to cannabis program requirements. It was noted that these changes are permanent, taking effect immediately and are to be followed with online guidance in the near future.

The changes implemented by Health Canada stem from an assessment of review processes and the results from inspections of licensed cannabis sites. According to Health Canada, inspection results to date demonstrate an overall high rate of compliance with the Cannabis Regulations, and support a reprioritization of resources to higher risk areas and reduced regulatory burden for low risk changes to licensed sites. The process improvements are summarized below:

Changes to Site Plan Approval Requirements

Effective immediately, licence holders are no longer required to submit an amendment for review and approval by Health Canada for the following site plan changes:

  1. Adding a new operations area within an approved building that already appears on your licence.
  2. Changing an operations area (e.g., change to cameras, locks, layout) within an approved building that already appears on your licence.

An “operations area” is defined as an area of the site – other than a storage area – where cannabis is present as a result of any activities conducted under a licence. For example, rooms dedicated to indoor growing, trimming, milling, drying, packaging, labelling, testing, etc. The changes noted above only apply to operations areas located in a building that is already authorized for the possession of cannabis. Furthermore, it includes all indoor grow areas but excludes outdoor grow areas.

The only exception is if the changes noted above result in a change to your Organizational Security Plan (OSP). If you change the OSP, you need to notify Health Canada by email within 5 days of making the change.

Keep in mind that approval from Health Canada via an amendment application is still required for the following site plan changes:

  • Changing a site perimeter, or physical barrier surrounding the site;
  • Adding a new building (where activities with cannabis will take place and will be required to be authorized on your licence);
  • Adding or changing a storage area; and
  • Adding or changing an outdoor grow area.

Licence holders who currently have an amendment application in queue with Health Canada for one of the site plan changes that no longer requires approval, can immediately begin to use these operations areas provided that the areas meet the applicable requirements of the Cannabis Regulations prior to their use, and an up-to-date site plan is made available upon request.  

If an amendment application has already been submitted in CTLS, Health Canada asks licence holders to complete one of the following:

  1. If the amendment is only for the addition or change of an operations area within an approved building that already appears on their licence: withdraw the amendment application in the Cannabis Tracking and Licensing System (CTLS) and send an email to: HC.licensing-cannabis-licences.SC@canada.ca indicating that you have done so. The withdrawal of the application in the CTLS is necessary to allow the submission of future amendment applications.
  2. If the amendment includes a combination of different amendment types, such as the addition or change of an operations area within an approved building that already appears on their licence and another amendment request (that continues to require approval): leave the existing amendment application in the CTLS. Health Canada will continue its review of the applicable portion of the amendment application.

Notice of New Cannabis Products

Under the Cannabis Regulations, a processing licence holder must provide the Minister with a written notice at least 60 days before making a new cannabis product available for sale (other than plant or seeds) that they have not previously sold. This is referred to as a Notice of New Cannabis Product (NNCP).

In order to streamline this process, Health Canada has introduced the following measures which can now be operationalized by processing licence holders:

  1. For dried cannabis or fresh cannabis, only one Notice of New Cannabis Product (NNCP) should be submitted to Health Canada to capture information about the various immediate containers sizes that will be made available for sale. The NNCP should include all the container sizes the licence holder intends to sell for the product; and
  2. Where one licence holder sells a cannabis product to another licence holder for which a NNPC was already submitted, the NNCP that has been already submitted is considered sufficient notice for the purpose of complying with subsection 244(1) of the Cannabis Regulations, as long as all elements of the cannabis product and its information and description is identical.

In addition to these two operational changes, based on how and when licence holders are currently submitting NNCPs, Health Canada has clarified two additional points:

  • NNCPs can be sent prior to a product being packaged and labelled as long as information elements remain consistent with the final cannabis product; and
  • Licence holders may send a NNCP to Health Canada prior to receiving approval of their sales amendment application. However, licence holders must have received authority to sell that class of cannabis products before making the product available for sale. The 60 day notification period must also have been met.

Health Canada reserves the ability to make further adjustments regarding these operational changes at any point. As always, licence holders are expected to comply with the Cannabis Act and its regulations. Should any non-compliance with the Cannabis Act or its regulations be identified, Health Canada will not hesitate to take further compliance and enforcement action, if warranted.

How we can help you

At Cannabis License Experts, we provide you with the guidance to plan your cannabis business, acquire funding, navigate the legal requirements, and acquire the appropriate licence for your operations. As the Canadian cannabis industry develops, more and more licensed producers will be needed to meet the demands of consumers.

Cannabis License Experts offers support from day one of starting your cannabis business, including strategic planning, floor plan preparation, site audits, SOPs, Preventive Control Plans (PCPs) and more.

Our Edibles Compliance division can provide you with a solid plan for your edibles business to help get your products on store shelves.

Contact us today to discover how we can license and legalize your cannabis business to meet federal or provincial regulations.

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