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 include:
NHP Regulations
The Natural Health Products Regulations, which came into effect in 2004, were created after many consultations with Canadian consumers, academics, health care practitioners and industry stakeholders.
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 of applications.
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 days.
Consumer Safety
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 statements.
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) Regulations
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) Regulations (NHP-UPLAR).
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.
Image with caption: "The Parliamentary Secretary to the Federal Minister of Health, Dr. Colin Carrie, during the February 2, 2013, announcement in Montreal, accompanied by the President of the Canadian Health Food Association, Mrs Helen Sherrard. (CNW Group/Health Canada)". Image available at: http://photos.newswire.ca/images/download/20130202_C2565_PHOTO_EN_23247.jpg
SOURCE: Health Canada
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