On December 1, 2015, Health Canada released a new
Site Licensing Guidance Document. The guidance document
outlines how the Natural and Non-prescription Health Products
Directorate (NNHPD) manages site licence applications submitted in
accordance with the Natural Health Products Regulations
(the "Regulations"). As a result, there are new
processes, timelines and forms for site licence applications and
Various types of evidence can demonstrate good manufacturing
Under the new guidance, applicants may demonstrate compliance
with the good manufacturing practices ("GMPs")
established in Part 3 of the Regulations by submitting a completed
Quality Assurance Report ("QAR"). Alternatively, it
may be possible to rely on:
Drug Establishment License ("DEL"),
Foreign Site Reference Number ("FSRN")
GMP Certificate from a Qualified Authority (i.e. a recognize
authority from another country or an authority member of the
Pharmaceutical Inspection Cooperation Scheme), or
NSF International Standard 173, Section 8 Dietary Supplements
Certificate with certain additional supporting documents;
The QAR form can be accompanied by other audits or inspection
reports to assist in demonstrating compliance, but this is not
required and accreditations not identified above are not sufficient
on their own to demonstrate compliance with the Regulations.
In addition, the QAR form itself has changed substantially. For
example, applicants are no longer expected to provide detailed
responses describing compliance or a rationale for non-compliance.
There is also less supporting documentation expected to accompany
QAR, though records and supporting documents are generally expected
to be available to Health Canada upon request and are still
required to accompany site licence renewals.
The evidence demonstrating GMP compliance will affect
The new guidance also sets out new service standards and
timelines, based on the type of GMP evidence and the number of
sites to be included on the licence. All new applications, renewals
or amendments will be examined for administrative completeness in
five business days, at which point an Application Acknowledgement
Letter or a Rejection Notice – Administrative Deficiency will
be sent to the applicant. Following the initial examination, all
submissions will be assessed and decided upon in the following
number of days:
If using pre-cleared evidence for every site – 30
If the application includes 1-9 sites and uses a QAR as
evidence – 60 days; and
If the application includes 10 or more sites and uses a QAR as
evidence – 90 days.
The new service standards apply to all applications received on
or after April 1, 2016.
It's also important to note that the above service standards
apply to both initial applications and renewals. As the NNHPD no
longer sends renewal reminder emails to site licence holders, the
onus is on the licence holder to track their renewal date and
submit the renewal package far enough in advance of licence
expiry, based on the applicable service standards.
Prepared with assistance from Nathan Piché.
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