When Health Canada Requests More Information
By Zara Munir, Quality and Regulatory Consultant
Cannabis Compliance Inc.
Picture this: your ACMPR Licensed Producer application has been submitted and is progressing through the standard milestones indicated by Health Canada. Then, it happens. An email directly from the ACMPR Licensing Division with the subject line “Request for More Information”. A daunting email, usually with an ominous “response must be submitted by the deadline provided to continue review of the application”. Before the end of the day you’ve read it to the point of memorization and time is moving faster than ever.
Each Request for More Information (RMI) follows a similar template. It starts with referencing a section of the ACMPR or Licenced Producer Application then trails off into a combination of open ended or very specific questions. These questions can range from obvious, to obscure, to “we already included this in the application”. Each request requires a response, and each response is equally important. Ultimately, it is Health Canada bringing their concerns directly to you, the applicant, for an official response.
Although questions are issued to provide Health Canada more information on your application, be advised that some questions are giving you an opportunity to correct non-compliance items or comment on concerns Health Canada has faced from other LPs.
Dissecting an RMI takes a clear understanding of quality, compliance, regulations and industry standards. Each question is carefully constructed by Health Canada’s Reviewers using the only language they can communicate in – regulations. By referring to the regulations, they must construct questions that communicate their concerns. Since there is a disconnect between what they want to ask and what they can ask, interpretation of the RMI is critical to a successful response – and ultimately, licence approval.
For example, you have repeatedly noticed a remark in your RMI correspondences that cannabis cannot be present on site until a cultivation licence is issued. Although you respond with an acknowledgement of this requirement, it keeps coming up citing different regulations each time. An RMI like this is likely to address a completely different concern such as existing operations at the site (i.e. personal grow or designated grow licences). Health Canada is actually requesting an attestation and evidence that other licences will not pose risk or cause diversion of product when your ACMPR cultivation licence is issued.
Overall, each question has an underlying concern and identifying that concern is Cannabis Compliance Inc.’s expertise.
Once RMIs are interpreted, formulating a response is next. Responses should be based on the ACMPR, Directive on Physical Security Requirements or industry standards specifically for cannabis (there are a lot of these, and new ones are appearing frequently). For some of the more complex questions, you can either choose the path of least resistance and make corrections to your application or prepare for a battle with Health Canada and defend what was originally presented.
Knowing when to defend and knowing when to concede takes guidance from industry experts who can creatively navigate through the regulations.
An unsatisfactory response jeopardizes your application timeline. You can expect Health Canada to continue the RMI process until they get the answers they require to ensure compliance, or until you have provided them enough information to convince them otherwise.
Therefore, there are high stakes when it comes to responses. You want to respond to their satisfaction the first time to avoid delays and additional processing. Back and forth with Health Canada also raises concern on your overall understanding of quality and compliance. As an applicant you want to present your team as knowledgeable, responsive and ready for a licence. Misinterpreting an RMI does the opposite of that.
Best practice for RMI responses is putting quality first, having compliant SOPs and implementing a robust Quality Management System. Responses should demonstrate that regulations will be applied in daily operations and not just in the response. Providing concrete quality-oriented procedures and documents as a part of your RMI response speaks for itself.
Investing in RMI support and having a consultant that can read, interpret and respond to RMIs effectively is critical for your application. CCI developed SOPs can independently be used to respond to RMI and demonstrate that best practices are integrated into daily operation at your proposed LP site. CCI can support on all aspects of RMI correspondence for applicants at any stage with Health Canada.
Cannabis Compliance Inc is the largest consulting firm in the world devoted exclusively to the cannabis sector. With over fifty full time staff, and projects stretching around the globe, our track record with regulating bodies is unparalleled – saving our clients hassle, time and lost opportunity. Contact us for more information.