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;
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
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
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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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