If you import, fabricate, package/label or test drugs in Canada,
then it is likely that recent regulatory changes will affect your
regulatory responsibilities. These changes expand the application
of licensing and Good Manufacturing Practices (GMP)
responsibilities to those in the drug supply chain who were not
previously subject to these requirements.
On November 8, 2013, amendments to the Food and Drug
Regulations came into force applying establishment licensing
and GMP provisions to active pharmaceutical ingredients (APIs) used
in drugs for human use. The amendments include a new definition for
APIs as active ingredients used to manufacture pharmaceuticals. The
term "active ingredient" is also defined and includes raw
material used in the fabrication of drugs that provides its
intended effect. These new requirements are aimed at ensuring the
overall quality and consistency of marketed drug products, and will
also allow for enhanced traceability of APIs from the original
manufacturer to the drug dosage form manufacturer.
Practically speaking, the amendments will affect a significant
portion of the industry. First, all establishments in Canada that
are fabricating, packaging/labelling, testing and importing APIs
will, before February 8, 2014, be required to hold a Drug
Establishment Licence (DEL) for that ingredient or to amend their
existing DEL to cover APIs. Secondly, importers of finished dosage
forms (who are not conducting any API activities in Canada) will be
required to submit an amendment to their existing EL by signing the
attestation to the GMP compliance status of the foreign buildings
where fabrication, packaging/labelling and/or testing of APIs occur
and submitting the Foreign Building Information Table to Health
Canada before February 8, 2014. Lastly, distributors and
wholesalers of APIs in Canada that import APIs from abroad will be
required to submit a DEL application to Health Canada before
February 8, 2014 to cover API importation activity and will be
subject to the applicable GMP requirements for API importers.
While Health Canada indicated that active ingredients used
solely in NHPs were not subject to the new requirements, the fate
of substances that may be used in pharmaceutical drugs as well as
NHPs, such as titanium dioxide, is unclear. For these products and
other OTC raw material ingredients, Health Canada is running a
pilot project which puts establishment licensing requirements on
hold, and instead requires the submission of
information supporting the GMPs for those ingredients as well
as traceability information.
As the average service standard for the review of DEL
applications by Health Canada is 250 calendar days, it may be
difficult to have on hand new or amended DELs by the February 8,
2014 deadline. However, as long as a complete application is
submitted prior to that date, Health Canada has indicated that
establishments will be able to continue to conduct API activities
until otherwise advised by Health Canada. We should note that this
lenience will not apply to new establishments proposing to start
licensable activities related to APIs on or after November 8, 2013
– new activities cannot commence until the establishment has
been inspected and deemed compliant by Health Canada, and a licence
In addition to its Frequently Asked Questions page,
Health Canada is preparing new guidance documents on GMPs for APIs,
and on the Inspection Policy for Canadian API Drug Establishments.
Information regarding the pilot project for manufacturers of
selected consumer health products and their associated APIs can be
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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