Health Canada has extended their temporary approach to administration and enforcement of the Cannabis act and its regulations today.
The regulator previously issued a memorandum from March 24 stating that there would be a modified approach to their enforcement and regulatory activities, such as a delay of on-site inspections, that would be in place until May 1, 2020. The newest memo notes the deadline has now been extended until June 30, 2020.
The Health Canada branch that deals with cannabis, the Controlled Substances and Cannabis Branch, like many other aspects of government, have had to shift their workload to handle employees primarily working from home. They have also had some of their workforce taken off the cannabis file and moved to other departments to address the ongoing COVID-19 health crisis.
The changes will continue to impact not only on-site inspections, such as those required for a cannabis sales licence, but will also impact things like the requirements for the on-site destruction of cannabis, off-site antimicrobial treatment and destruction, and in some limited cases allow for verbal confirmation for associated medical authorizations.
In lieu of on-site inspections, Health Canada says applicants will now be required to participate in “compliance promotion sessions” with inspectors and may, in some cases require licence holders to undergo a paper-based or virtual inspection.
However, Health Canada says they are also continuing to look at new ways to conduct necessary inspections without compromising health and safety of inspectors, regulated parties, or the general public.
For on-site destruction of cannabis, which normally requires those with relevant security clearances to be present and witness the destruction, the branch says they are open to allowing a virtual visual observation for those unable to attend personally due to directly COVID-related issues. For off-site destruction or for processes such as irradiation, Health Canada says they will be open to allowing a modified approach to their requirements of having a security-cleared individual to be present with the cannabis, in cases where COVID-related precautions make their physical presence not viable.
The branch says they will continue to provide more guidance to the industry as the issue unfolds.
Full text below:
As part of our commitment to ongoing communication with the cannabis industry during the COVID-19 pandemic, you will find below information and updates on key areas that have been the subject of numerous questions over the last few weeks.
Extension of temporary approach to the administration and enforcement of the Cannabis Act and its regulations
On March 24, 2020, Health Canada announced that in view of the resource implications and operational challenges posed to the cannabis industry by the pandemic, the Department was temporarily adjusting its approach to the administration and enforcement of the Cannabis Act and its regulations in areas related to licensing, security clearances, inspections and reporting requirements. Given the current state of advice from public health officials, today we are announcing that this temporary approach is being extended to June 30, 2020. Please refer to the attached email from March 24, 2020 for details on the adjustments that are covered by this extension.
In our March 24, 2020 message, we informed you that sales inspections requiring onsite verifications would be postponed. We also committed to monitor the situation, remain flexible, and adapt our approach to continue to ensure the health and safety of Canadians. In response to the requirements for physical distancing and limiting domestic travel in response to COVID-19 and in an effort to continue to support our cannabis licence holders, Health Canada is announcing today an interim approach for amendment applications to add the authority to sell a new class of cannabis.
In place of onsite verifications for sales amendments, applicants will be required to participate in a compliance promotion session with Health Canada inspectors. In some cases, based on risk, the licence holder may be required to undergo an inspection via paper-based review and/or a virtual component, prior to any sales decisions.
The compliance promotion session will require mandatory participation of key individuals/positions as listed in the application (i.e., Responsible Person (RP), Quality Assurance Person (QAP), and alternates) and will provide an opportunity for applicants to ask questions of inspectors.
This approach will be applied to new applications and applications already submitted but where the inspection has not taken place.
Over the next few weeks, additional details on the process and requirements will be provided directly to licence holders impacted by this temporary change.
Other Inspections and Compliance Verifications
Other inspections will continue in accordance with the program’s risk-based approach, and will focus on activities that represent the highest risk to public health and safety. This means that inspections requiring onsite verifications will be postponed until June 30, 2020. During this interim period, Health Canada is evaluating additional ways to conduct inspection work, including evaluating records in lieu of conducting an onsite inspection and using other tools and technologies at our disposal to carry out inspections and compliance verifications, when appropriate.
On-site destruction of cannabis
The Cannabis Regulations require that a licence holder is authorized to destroy cannabis when the destruction is witnessed by two qualified individuals, as defined in the regulations. In the event that an individual who holds a security clearance is not physically able to be present at the licence holder site as a result of operational constraints due to COVID-19, the witnessing of the destruction of cannabis by this individual can be done virtually (e.g., using a camera). A copy of the video must be retained and the virtual witnessing must be noted in the destruction records.
As mentioned in the email of March 24, 2020, in circumstances where a licence holder does not have enough security cleared individuals due to self-isolation or illness, licence holders can temporarily designate an appropriate alternate based on their own internal risk assessment, and notify Health Canada by sending an email to: [email protected]. The email should include your licence number and “COVID-19” in the subject line, and the name of the individual, their role and the date upon which they will assume responsibilities, in the body of the email.
Presence required during off-site antimicrobial treatment and destruction
The Cannabis Regulations require that a qualified individual be present at all times during the antimicrobial treatment or destruction of cannabis off-site. It is understood that physical distancing rules at certain facilities, such as those providing irradiation treatment or destruction (e.g., landfills), may prohibit the entrance of these individuals to witness this activity.
As such, the security clearance holder, or the alternative individual that has been temporarily named during COVID-19, must accompany the cannabis until it enters the facility. Once antimicrobial treatment is completed, this individual must accompany the cannabis back to the licence holder’s site. For destruction, the licence holder must fulfill any witnessing requirements (e.g., virtually) and record the effective date of destruction, as provided by the off-site facility, in their destruction records. Off-site facilities must operate under a contract with the licence holder to be permitted to possess and obtain cannabis, and the licence holder remains responsible for the cannabis while it is at the off-site facility.
Verbal confirmation from patients in lieu of a signature
Some licence holders have reported difficulties with completing the registration process under the telemedicine appointment model, as some patients are unable to sign and date the application in accordance with paragraph 279(2)(g) of the Cannabis Regulations.
Licence holders are encouraged to use their normal procedures for completing the signature step whenever possible, and to use reasonable efforts to overcome any challenges with technological solutions such as email, online or fax acknowledgements or agreements. However, Health Canada also recognizes that there may be a small number of patients, who face challenges in completing registration steps online or by email.
As a temporary measure, in the rare circumstances where a physical sign-off is not possible, Health Canada considers verbal confirmation to be acceptable. When these circumstances arise, we require you to consistently record the details of each verbal confirmation, including who conducted the call, who provided the verbal confirmation, the phone number, the date and time, and the information that was verified with verbal confirmation. We also require you to have appropriate standard operating procedures documenting how the identity of the person was confirmed. Lastly, verbal confirmations should be tracked throughout the COVID-19 pandemic so that hard copy documentation can be secured when regular business practices resume.
In closing, we want to reiterate that we understand this is a difficult time for business owners and for all Canadians. We are working hard to ensure you have the information you need in a timely fashion. In the interim, we hope the measures taken by Health Canada to date and those announced above are helpful to you as we collectively navigate our way through these uncertain times.
Should you have any questions, please send them to [email protected].