Federal license holders (and applicants) under the Cannabis Act and Regulations were already facing difficult industry challenges prior to the coronavirus (COVID-19) pandemic. In addition to facing the business impact of COVID-19 in the form of staffing and operational disruption, license holders were recently advised that Health Canada is temporarily adjusting its approach to administering/enforcing the Cannabis Regulations due to the COVID-19 virus and the shift Health Canada has made to teleworking for cannabis licensing staff.
In light of recent developments and against the backdrop of the unprecedented business situation we currently face, David Hyde, Paul Kourie and the CannaNavigators team is offering COVID-19 business consultations of up to 30 minutes at no charge to federal cannabis licence holders and applicants. Please complete the form below to set up a time to speak with us.
Please see below some of the important information provided by Health Canada and the implications to licence holders and applicants:
Health Canada has advised that licence applications will still be processed but that certain tasks will be prioritized (e.g., evidence package review, Security Clearances). It is important for applicants to align their licensing strategy and timeline with this new reality.
Health Canada has advised that quality control, testing, recall capacity and security controls will be specific focus points for the Regulator. They should be focus points for licence holders too.
Health Canada has advised that license holders must continue to comply with the Cannabis Act and Regulations and that non-compliance will be met with enforcement action. Licence holders must adapt to compliance in the face of modified staffing and other strains on operations.
Health Canada has advised their resources will focus mainly on license amendments and security clearance applications that meet a "high priority" threshold. It is critical that licence amendments and security clearances be approached and communicated strategically to allow licence holders to execute on their business plans.
Health Canada has advised that licence holders can flag "high priority" licence amendments and security clearance applications for expedited processing but that a clear justification must be provided. It is critical that licence holders re-visit their licence amendment strategy and take steps to optimize and communicate it effectively to avoid critical business disruption.
Health Canada has advised that adjustments will be made to facilitate more expedient license renewal during the temporary COVID-19 response period. Licence holders should be proactive with the renewal of their licence if it falls before September, 2020.
Health Canada has advised that if license holders don’t have enough security cleared individuals due to self-isolation and/or illness, they can temporarily designate a suitable alternate based on an "internal risk assessment". It is critical that an overarching security clearance strategy and contingency plan be put in place and that criteria and framework for an internal risk assessment be created and formalized.
Health Canada has advised that where licence holders appoint a non-security cleared alternate in a security-cleared role, they must ensure an appropriate "risk mitigation plan" is in place so that GPP, physical security and record-keeping regulatory requirements can be maintained. Licence holders should ensure they have a robust and formalized risk mitigation plan in place tailored to their specific circumstances and risk profile.
Health Canada has advised that inspections will continue but will be focused on activities representing the highest risk to public health and public safety. All types of sales-related inspections are postponed during this period, but Health Canada may consider conducting inspections on a "case-by-case basis", as needed. Licence holders with current or impending sales licence inspections need to re-visit their strategy and chart the most appropriate course. Where a sales licence inspection is deemed mission-critical, licence holders must be able to clearly articulate the reasons to Health Canada in making a special request for inspection.
Health Canada advised that although license holder reporting requirements under the Cannabis Act and Regulations should be maintained, there will be flexibility if reports need to be updated/revised at a later date. Licence holders should make every effort to maintain all reporting requirements but a process should be put in place to re-visit what was reported and to make adjustments as/where necessary.
In addition to the COVID-19-related information provided by Health Canada and more generally, it is also important for all licence holders and applicants to prioritize business continuity planning (including pandemic planning) and emergency response.
Please complete and submit the below form to register your request for an up-to-30 minute, no-cost business consultation with the CannaNavigators team.