A successful application under the Marihuana for Medical Purposes Regulations (MMPR) requires, amongst other things, the selection of an appropriately qualified Quality Assurance Person (QAP). In addition to finding a qualified QAP, applicants should be aware of certain complexities that may arise with the QAP's position. One notable complexity which has received little guidance is the ability of a Licensed Producer (LP) to continue operations in the absence of its QAP.
The QAP Gap
Division 4 of the MMPR sets out "Good Production Practices" relating to the requirements of quality assurance that an LP must continually satisfy.
Under Division 4, the QAP is solely responsible for:
- ensuring that proper procedures are followed in the production, packaging, labelling and storing of dried marihuana;
- approving every batch of dried marihuana before it is made available for sale;
- investigating any complaints received with respect to quality; and
- addressing any recall issues (a responsibility the QAP must always be available for).
- It is important to understand that LPs are permitted to have one designated QAP and that QAP may not delegate his/her duties. As a result, applicants and LPs should consider how to handle both short-term and long-term QAP absences because failing to prepare for such situations could lead to stalled operations and, possibly, license suspension and/or revocation.
Filling the Gap
Short Term Absences
If faced with a short term QAP absence (e.g., vacation, illness, emergency, etc.), the goal of any LP should be to avoid material production delays or stoppages. LPs must ensure that regulated activities are conducted in strict compliance with approved standard operating procedures and that proper record keeping is accurately maintained in order to allow the QAP to efficiently and accurately review and approve the activities undertaken in the QAP's absence upon the QAP's return to work. LPs should also coordinate the QAP's planned absences (e.g., vacation) sufficiently in advance as to allow the LP to schedule production cycles such that batch approvals are not required during the QAP's absence.
Long Term Absences
In the event of a long term absence, an LP may request a temporary modification to the QAP designation from Health Canada. Ideally, this information should be provided in advance of the absence as there is a risk of facing a material delay while Health Canada conducts the required review and security clearance for the new QAP. Once the new QAP is approved, the original QAP will lose his/her status and if the original QAP is able to return, it will be necessary to amend the application by following the same procedure.
To our knowledge, Health Canada does not currently allow an LP to "pre-approve" an alternate QAP. In our view, this is a material deficiently with the MMPR as currently applied as it creates substantial risk to the operations of an LP should its QAP be subject to an unexpected and prolonged absence.
Preparing a contingency plan for a QAP absence is important for any LP or LP applicant as any dried marihuana produced during the QAP's absence will not be available for sale until approved by the QAP.
Becoming an LP is a time consuming and potentially expensive process. Careful advance consideration of regulatory, commercial and operational risks will help LPs and LP applicants avoid unforeseen pitfalls. At Bennett Jones we have a team of experienced and dedicated professional advisors that can help you navigate to MMPR regulatory regime and minimize risk so that you can focus on growing your business.