Written by Angela Blake, Dominique Hussey and Aaron Sonshine
On April 30, 2020, Health Canada announced the extension of temporary relief measures, initially announced on March 24, 2020, for Canadian licence holders in connection with the COVID-19 pandemic, as well as some new temporary relief and guidance. The relief measures have now been extended to June 30, 2020.
While Health Canada’s priority continues to be protecting public health and safety, and preventing the diversion of cannabis to the illicit market, it has temporarily adjusted its approach to the administration and enforcement of the Cannabis Act to facilitate the ongoing operations of licence holders in the current environment.
To address the reality that physical distancing requirements and travel restrictions remain in place, Health Canada has now introduced an interim approach to facilitate licence amendments for authorization to sell a new class of cannabis. Health Canada is not requiring on-site verification, and has provided some additional interim accommodations:
- Instead of on-site verifications for sales amendments, applicants will participate in a compliance promotion session with Health Canada inspectors, which may include an inspection via paper-based review and/or a virtual component.
- While on-site inspections will likely be postponed until June 30, 2020, Health Canada is evaluating additional ways to conduct inspections, including reviewing records in lieu of an on-site inspection, and using other tools and technology to carry out inspections and verifications where appropriate.
- If an individual who holds a security clearance cannot be physically present at a licensed site due to COVID-19 constraints, that person may witness the destruction of cannabis virtually, provided that a copy of the video of the destruction is retained and the virtual witnessing is noted in the destruction records.
- If a qualified individual cannot enter an off-site facility where cannabis is being destroyed or undergoing antimicrobial treatment (irradiation) due to physical distancing rules, that individual must accompany the cannabis until it enters the facility and accompany the cannabis back to the licence holder’s site (unless the cannabis has been destroyed, in which case any witnessing requirements must be fulfilled virtually). Off-site facilities conducting these activities must operate under a contract with the licence holder to be permitted to possess and obtain cannabis, and the licence holder will remain responsible for the cannabis at the facility.
- While licence holders are encouraged to use reasonable efforts during the COVID-19 pandemic to obtain patient signatures in the medical cannabis client registration process, in the rare case where a physical signature is not possible, Health Canada will permit a verbal confirmation from the patient. Licence holders will be required to record: the phone number, date and time of the confirmation call; who conducted the call; who provided the verbal confirmation; and the information that was verified with the verbal confirmation. Hard copy documentation must be obtained from the patient when regular business practices resume.
In addition to the above, the following previously-announced temporary relief measures and guidance remain in place:
- Health Canada will attempt to prioritize applications for licence amendments and security clearances that are critical to support a licence holder's operations during the pandemic response period if the licence holder emails Health Canada with an explanation of why the amendment or security clearance is critical to current operations.
- The filing deadline for 2019 annual promotions reports has been extended to June 30, 2020, however all efforts should be made to submit monthly cannabis tracking system reporting by the usual deadline of the 15th of each month. If necessary, these reports can be updated and revised at a later date.
- While cannabis must not be removed from a licensed site except in connection with regular business operations, certain activities that do not require physical possession of cannabis may be conducted off-site, including activities to facilitate the sale of cannabis (such as answering phone calls, registering medical patients, providing product information and taking orders), and entering data and information to comply with monthly reporting requirements on the CTLS.
- A licence holder that does not have enough security cleared personnel, due to self-isolation or illness, can temporarily designate an alternate based on an internal risk assessment, provided that any alternate designated must: (i) be capable of filling the role; (ii) not have had any previous security clearance application refused, suspended or cancelled; and (iii) not pose an unacceptable risk to public health and safety, taking into account the factors set out in section 53(2) of the Cannabis Regulations. It is important to note that Health Canada approval will still be required for adding any Quality Assurance Person, but Health Canada will attempt to prioritize such applications where critical to operations.
- Health Canada is considering extending the deadlines for renewal of licences that are scheduled to expire in the near future, although no firm decision has been communicated on this point.
- To facilitate the manufacture of products such as hand sanitizers needed for COVID-19 response efforts, Health Canada has clarified that pre-approval is not required for the manufacture of products that do not contain cannabis at a licensed facility. However, licence holders should notify Health Canada if they intend to do this, with details of the measures they will put in place to prevent the contamination of cannabis and ingredients to be used in cannabis products.
- If a licence holder has an export permit expiring in the near future and is unable to complete the shipment due to COVID-19 related issues, Health Canada will consider extending the period of validity of the permit, provided that the permit will still expire concurrently with any expiry of the applicable cannabis licence, and the validity period will not be extended beyond a maximum of 12 months. Health Canada may also allow permit holders to use an alternate port of exit or entry for import and export shipments.
- In the event a licence holder is unable to package product on the packaging date printed on a label, Health Canada will accept a printed packaging date that is four or fewer days before or after the actual packaging date. However, if this date accommodation is relied on, the licence holder must explicitly address it in the event of any recall of the applicable product.
Except as provided in the temporary relief measures, licence holders are expected to continue to comply with the Cannabis Act and its associated regulations, including with respect to quality control, testing, recalls and security controls. Health Canada will continue to provide guidance with respect to matters affecting licence holders generally, rather than responding to individual questions, and may provide updates with respect to frequently asked questions from time to time.
If you have any questions about the above, including about how to contact Health Canada with respect to any of the temporary relief measures, please contact the Bennett Jones Cannabis group. In addition, please visit our COVID-19 Resource Centre for other COVID-19-related materials.