Last month marked the end of the Natural Health Products
(Unprocessed Product Licence Applications)Regulations. As of February 2013, Health Canada will no longer issue new
Exemption Numbers (ENs) for Natural Health Products (NHPs).
In 2004, the Natural Health Products Regulations came
into force, prohibiting the sale of unlicensed NHPs in Canada. At
that time, there were an estimated 40,000 NHPs already on the
market that did not comply with the new Regulations. As a
result, Health Canada was flooded with NHP licence applications. By
2010, Health Canada had processed approximately 40,000
applications, but was still experiencing a sizable backlog.
The Unprocessed Product Licence Regulations, which came
into force on August 4, 2010, were introduced as a temporary
framework within which NHPs awaiting receipt of marketing
authorization (i.e., unlicensed NHPs) could be sold safely and
legally in Canada.
Under the Unprocessed Product Licence
Regulations,manufacturers could be granted an EN and deemed to
hold a valid product licence provided that certain filing
requirements were fulfilled and safety criteria were met. Health
Canada is now moving away from that temporary framework towards the
requirement that by September 1, 2014, all NHPs sold in Canada must
have a Natural Product Number (NPN) or Homeopathic Medicine Number
The new requirement will be implemented using a two-stage
Stage 1 (March 1, 2013 to November 30, 2013)
During the first stage, Health Canada will focus on promoting
awareness of the Natural Health Products Regulations and
working with industry to ensure understanding of the new
Businesses should use this time to review their products and
phase out any NHPs at the retail level with non-compliant
formulations, labelling or packaging.
Health Canada will prioritize its enforcement efforts during
this stage, with less priority being given to NHPs that have an
active submission number and products for which the labelling has
not yet been updated to reflect minor modifications. These products
will be subject to high priority enforcement measures, however, if
risks to health or additional non-compliances are identified.
Stage 2 (December 1, 2013 to August 31, 2014)
During the second stage of the transition plan, NHPs at the
importation and manufacturing levels will be expected to have
received marketing authorization and comply with its terms,
including with respect to formulations, packaging and
Businesses should continue to conduct an internal review of
their NHPs during this stage to ensure compliance with the
Natural Health Products Regulations.
Implementation Date (September 1, 2014)
By September 1, 2014, all NHPs imported into, manufactured or
sold in Canada will be expected to have an NPN or DIN-HM. NHPs
without marketing authorization may be subject to compliance and
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