As of December 1, 2013, manufacturers, importers, packagers, and
labellers ("supply chain members") must have a market
authorization (i.e. a natural product number (NPN)) for their
products and the products must comply with the terms of that market
authorization, including formulation and labelling. Supply chain
members cannot sell non-compliant NHPs to distributors or
retailers. Distributors and retailers can continue to sell existing
inventory of NHPs that have an active submission number or have
been approved with minor modifications still to be incorporated on
the label, as long as these products do not pose a risk to health
As Phase 2 is really the beginning of Health Canada
compliance and enforcement activity it is difficult at this time to
predict just how much activity to expect or where their efforts
will be focussed. However, it is likely that there will be
increased activity at the border as it is a continuous opportunity
for inspection. Canada Border Services Agency will verify that
imported NHPs have an active market authorization and will
generally refuse entry into Canada for non-compliant products.
Where NHPs are imported for re-labelling or modification,
notification to Health Canada will be required and the product must
be relabelled within 3 months of importation. Health Canada has not
published any information with respect to how notification and
relabeling verification is to take place.
This Phase of NHP compliance and enforcement will be in effect
until August 2014. Starting September 1, 2014, Health Canada will
expect full compliance by the supply chain members, as well as
distributors and retailers, with respect to the import,
manufacture and sale of NHPs.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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