New streamlined approach improves access and safety
MONTRÉAL, Feb. 2, 2013 /CNW/ - Canadians now have access to more than
60,000 licenced natural health products as a result of the Government
of Canada's more efficient approach to authorizing these products,
Parliamentary Secretary of Health, Dr. Colin Carrie announced today.
"The safety of Canadians is always our number one priority," said
Parliamentary Secretary, Dr. Carrie at the Canadian Health Food
Association Trade Show in Montreal. "This efficiency allows for
industry innovation and growth, while still assuring consumer safety
and access to a wide range of authorized natural health products."
In 2010, Health Canada brought in the Unprocessed Product License Applications Regulations (UPLAR) which allowed for the legal sale of lower-risk products while
their applications were under review. UPLAR, brought in as a temporary
measure, ends February 4, 2013. The Government has now introduced a new
approach to natural health products that provides a stable, predictable
regulatory environment for the efficient processing of applications.
The efficiencies gained under the new approach have set the foundation
for how applications are now processed.
Within the new approach, the measures in place to protect consumer
safety stay the same. Companies still need to provide sufficient
evidence that their products are safe and effective, and products
continue to be labelled with necessary warnings.
"Many Canadians use natural health products every day and want access to
a wide range of safe and effective products," added Parliamentary
Secretary, Dr. Carrie.
The new approach is in keeping with the authority of the Natural Health Products Regulations, which have been in place since 2004 and continue to set the standard
and requirements for authorizing natural health products in Canada.
INFORMATION FEBRUARY 2013
REGULATING NATURAL HEALTH PRODUCTS IN CANADA
What is a natural health product (NHP)?
Natural health products refer to a group of health products that
vitamin and mineral supplements
herbal and other plant-based health products
traditional medicines, such as traditional Chinese medicine
probiotics and enzymes
some personal care products like toothpastes and sunscreens that contain
The Natural Health Products Regulations, which came into effect in 2004, were created after many consultations
with Canadian consumers, academics, health care practitioners and
These Regulations help give Canadians access to a wide range of natural
health products that are safe, effective and of high quality.
Under the regulations, to be legally sold in Canada, all NHPs must have
a product licence, and the Canadian sites that manufacture, package,
label and import these products must have site licences.
New Approach to NHPs
The Government has introduced a new approach to NHPs that provides a
stable, predictable regulatory environment for the efficient processing
The new approach introduces new policies and process improvements to
speed up application review and focus evaluation efforts on complex
applications. These changes are complemented by newly revised guidance
on the requirements and pathways for licensing NHPs. The Department is
also developing a new approach to site licensing focused on greater
quality assurance for products.
From now on, product licensing decisions will be made in 180 days or
less. Decisions on certain types of products will be made within 30
Safety remains the top priority. The policies under the new approach do
not change the measures in place to protect consumer safety. The level
of evidence required to demonstrate safety remains the same, and
products will continue to be labelled with required cautionary
Companies are still required to submit reports of serious adverse
reactions (ARs). This will not change. Health Canada will continue to
collect, monitor, and analyze ARs to NHPs through the Canada Vigilance
Program. The Department is also developing new tools for monitoring NHP
ARs in the Canada Vigilance database.
Temporary Natural Health Products (Unprocessed Product Licence Applications)
When the Natural Health Product Regulations came into effect, they captured a large number of products that were
already on the market and needed to be licensed. This created an
immediate large number of unprocessed applications.
To address this, the Government introduced a temporary set of
regulations in August 2010 called the Natural Health Products (Unprocessed Product Licence Applications)
NHP-UPLAR provided a short-term way for products to be legally sold when
Health Canada had not completed its licensing decision within 180 days.
NHP-UPLAR, which ends February 4, 2013, will no longer be needed because
the Government has introduced a new approach to the regulation of NHPs.
The repeal of NHP-UPLAR does not change Canadians' access to NHPs.
Companies wishing to sell NHPs will continue to apply for licences
under the Natural Health Products Regulations. In fact, Health Canada will provide a transition period - developed
using key input from stakeholders - that provides time for companies to
make necessary adjustments to business practices and/or to phase out
products that are not in compliance.
SOURCE: Health Canada
For further information:
Office of the Honourable Leona Aglukkaq
Federal Minister of Health
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