The Natural Health Products (Unprocessed Product Licence
Applications) Regulations (NHP-UPLAR) was repealed as
of February 2013 as planned. This means that new natural health
products (NHPs) will no longer be issued an exemption number (EN)
and products currently operating under an EN will need to be
brought into compliance with the Natural Health Product
Regulations (NHPR) or phased out. With
NHP-UPLAR phased out, EN’s no longer have the
intended effect under NHP-UPLAR.
Health Canada has released details on the transition plan to
address the repeal of NHP-UPLAR. The transition will take
place over 18 months, divided into 2, 9-month phases. As of
September 1, 2014 when the transition ends, all NHPs will be
required to have natural product number (NPN) or a Homeopathic
Medicine Number in order to be sold at the distributor/retail level
or at the manufacturing/importer or packaging/labelling level.
Phase 1: March – November 2013
During Phase 1 of the transition period Health Canada will be
focussed on promoting awareness of and compliance with the
NHPR with manufacturers, importers, packagers, and
labellers (“supply chain”). NHPs that have an active
submission number or have been approved with minor modifications
still to be reflected in the labelling will generally not be
targeted for enforcement. Issues relating to risk will always bring
about compliance action.
If you are a member of the supply chain and selling a product
under an EN during this period because it is still being reviewed
by Health Canada (i.e. has an active submission number) no action
is likely required. If, as a supply chain member, you are selling a
product under an EN because your NPN requires modification to the
product label (including updating labels to indicate
“NPN” rather than “EN”) you should begin
the process of making these modifications so that they can be
reflected on the next label run and you can begin distributing
compliant products by the November 30, 2013 deadline. If, as a
supply chain member, you have any other products that do not have
an NPN, you should begin phasing them out, including winding down
import and manufacturing activities, unless you feel by the end of
November 2013 an NPN will be issued for the product. The key for
this phase is that members of the supply chain should ensure that
by December 1, 2013 only products that are issued an NPN are sold.
It is expected that there will likely continue to be some latitude
with respect to labelling as long as the product has been issued an
NPN and the nature of the label deficiency does not give rise to a
risk to the health of the consumer.
Phase 2: December 2013 – August 2014
When Phase 2 of the transition period begins in December 2013,
supply chain members will no longer be permitted to sell NHPs
without an NPN having been issued for the product. During Phase 2,
NHPs without an NPN can still be sold from inventory of
distributors or retailers. This 9-month period ending September 1,
2014 allows for distributors and retailers to sell-off existing
inventory of products which have not received an NPN.
Full Compliance: September 1, 2014
Starting September 1, 2014 supply chain members, as well as
distributors and retailers, will only be permitted to import,
manufacture and sell NHPs which have been issued an NPN under the
NHPR and are in compliance with the terms of the market
authorization. It is suspected that the NHP Directorate will
continue to work diligently to review those past backlog (August
2010) submissions that remain in the queue. This may further reduce
the amount of products that will have to be withdrawn from the
marketplace by September 1, 2014.
Prepared with assistance from Katrina Coughlin
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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