The NHPD's system for approving foreign manufacturing sites relies entirely on indirect evidence and does not involve on-site inspections. This has created challenges for both the NHPD and importers. Importers are having difficulty obtaining the required documentation for approval, resulting in shipments being held. It is easiest to obtain approval for sites in countries that have Mutual Recognition Agreements with Canada, as these countries' GMP regulations are considered equivalent to Canada's. Importers are advised to work closely with sites in non-MRA countries to properly complete the required Quality Assurance Report.

1. The NHPD’s system for approving for-
eign manufacturing sites is unique in
that it relies entirely on indirect inspection
evidence. Approval does not involve on-
site inspection by Health Canada inspec-
tors or third party auditors.
This system has created challenges for both the NHPD and
Canadian importers. For instance, NHPD is being bom-
barded with Site License applications (QARs) in which
importers are submitting a variety of different business
models that don’t fit neatly into the current regulatory
framework. NHPD recognizes this and evaluates import-
ers on a case-by-case basis.
Further, Canadian importers are having difficulty obtain-
ing the correct documentation required to obtain approval
of a foreign site. This has resulted in shipments from unap-
proved foreign sites being held at Canadian Customs ware-
houses.
Foreign manufacturing sites are approved based on NHPD’s
review of documents that provide evidence of compliance
to Canadian GMP. A certificate of GMP compliance origi-
nating from a regulatory agency in a MRA country is easi-
est to obtain and is accepted by NHPD.
The Mutual Recognition Agreement (MRA) system signi-
fies Health Canada’s official recognition of the equivalency
of a foreign country’s GMP regulations to the Canadian
GMP’s. Canada has MRA agreements with countries in
the EC, the European Free Trade Association (EFTA) and
Australia. It is easiest for Canadian importers to obtain ap-
proval of foreign sites located in these countries.
Importers should be aware that foreign sites in European
MRA countries that have been inspected may provide a
variety of different documents including inspection no-
tices, inspection reports/findings, production licenses, and
1-page certificates asserting GMP compliance. This variety
is due to the large number of cultures, languages and sys-
tems in the EC and EFTA.
In general, only the 1-page certificate of GMP compliance
(less than 3 years old) is considered acceptable. The certifi-
cate must be written in English or French or be officially
translated. Importers who have other documents attesting
to GMP compliance of a foreign site are advised to consult
NHPD to confirm acceptability.
For foreign sites in non-MRA countries, the completed
QAR is required as evidence of GMP compliance. It is rec-
ommended that Canadian importers initiate and drive the
preparation of the QAR, rather than leaving it to the for-
eign site to complete. Otherwise, the form will inevitably be
filled out improperly. The importer can consult with NHPD
or a third party consultant for guidance. An improperly
completed QAR can be easily avoided and which otherwise
results in extended review time, delayed approval, or rejec-
tion by NHPD.
With the new NHPD regulations being in their fourth year
of implementation, new and unique challenges continue to
arise for the industry. Continued debate about policies and
regulations continue to evolve.
Fenton Fong is a Senior Consultant
at PharmEng Technology Inc.
For further information, please email Fenton at:
fenton.f@pharmeng.com or visit www.pharmeng.com
Importers and Approval of Foreign Sites
By Fenton Fong, MSc. PharmEng Technology Inc.
Manufacturing Solutions80