Thread by @davidhyde2

Health Canada has advised all federal license holders it’s temporarily adjusting its approach to administering/enforcing the #Cannabis Act & Regulations due to #COVID19 & its shift to teleworking. The changes will have major impacts which I will highlight in a series of Tweets /1

HC: License holders are encouraged to share any concerns; however, grouped responses to questions will be provided & not individual responses.

DH: My team is already collecting relevant questions from our clients & will submit en masse in hope of expedient response from HC. /2

HC: The temp adjustments to admin & enforcement of Cannabis Act/Regs will go 'til May 1/2020, at which time they'll be re-evaluated.

DH: Given current & projected realities I expect some type of modified approach to cannabis licensing & enforcement to continue past that date. /3

HC: Quality control, testing, recall capacity and security controls will be specific focus points for the Regulator during this temporary period.

DH: Licence holders should pay particular attention to maintain strict compliance in the identified areas above. /4

HC: Even in current climate, license holders are expected to continually comply with Cannabis Act/Regs. Non-compliance will be addressed through enforcement action, if needed.

DH: Licence holders MUST NOT get complacent in maintaining regulatory compliance. Cameras don't lie! /5

HC: Resources will focus mainly on license amendments & security clearance apps that meet a "high priority" threshold. Adding storage rooms & changing personnel in operational roles identified as examples.

DH: Licence holders must adjust their amendment strategy accordingly! /6

HC: High priority amendments/security clearance apps must be flagged to HC with COVID-19 in email subject line. LH's must include a clear explanation why amendment/security clearance is critical to current operations.

DH: Critical that rationale be spelled out. BS won't fly! /7

HC: Adjustments will be made to facilitate more expedient license renewal during the temporary COVID-19 response period.

DH: HC should contact you if your renewal falls in the next 3 months but be proactive ahead of time if you don't hear anything. /8

HC: If license holders don’t have enough security cleared ppl due to self-isolation/illness, they can temporarily designate a suitable alternate based on an "internal risk assessment".

DH: LH's must explain rationale behind selection & show how they assessed associated risks. /9

HC: Licence holders must notify HC of security-cleared alternate, identify their role and name them. They must be capable of fulfilling applicable regulatory duties & have not had a cancelled/suspended security clearance.

DH: Choose, explain & prepare alternate carefully! /10

HC: LH's must ensure an appropriate "risk mitigation plan" is in place so GPP, physical security & record-keeping regulatory requirements can be maintained.

DH: Risk mitigation plan should focus on the specific security-cleared role/regulatory duties & be clearly articulated /11

HC: Health Canada approval is still required for adding a quality assurance person due to the technical requirements of this role. Any such applications would be a priority.

DH: If you need a new QAP, select carefully & enter COVID-19 in subject line of email to HC Licensing /12

HC: Inspections will continue focused on activities representing the highest risk to public health and public safety.

DH: Don't let your guard down! Find a way to maintain regulatory compliance and if forced to deviate in minor ways, deviation report, change control, etc! /13

HC: All types of sales-related inspections are postponed during this period. HC may consider conducting inspections on a "case-by-case basis", as needed.

DH: Plan around delays in sales licence issuance. Make a case for an exception if justifiable (it'll be a high bar!) /14

HC: 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.

DH: Do your best but if there are issues, be able to go back and update/revise. /15

HC: In closing, Health Canada advised they're working to finalize answers to all questions received from LH's as quickly as possible but in the interim hope the information provided would be helpful.

DH: I expect a set of FAQ responses soon (we will respectfully push!!) /16

To be clear (& thanks to my friend @trinafraser for clarifying) the temporary allowance by HC is to appoint a NON-security cleared person into an operational role requiring a Security Clearance where security-cleared person(s) for these roles are sick/self-isolating re #COVID19

My advice is to select the nominated non-security cleared person(s) carefully, prepare a proper internal risk assessment & ensure the alternate person is fully able& prepared to fulfill the security-cleared role as set out within a formal risk mitigation plan (as per HC guidance)