It is with pleasure that we are announcing that the new Natural Health Products
Regulations (NHP Regulations) were published in the Canada Gazette, Part II on June 18,
2003. The NHP Regulations will come into force on January 1, 2004, with a transition
period ranging from two years (for site licensing) to six years (for product licensing,
for products already issued a Drug Identification Number).
These Regulations are the result of a comprehensive and inclusive consultation
process with Canadian consumers, academics, health care practitioners and industry
stakeholders, and are a key element in fulfilling the Standing Committee on Health's
53 recommendations on natural health products. They place requirements on people who
manufacture, package, label, import or distribute NHPs, and are intended to regulate
substances that are safe for over-the-counter use. The role of the Natural Health
Products Directorate is to ensure that Canadians have ready access to natural health
products that are safe, effective, and of high quality while respecting freedom of
choice and philosophical and cultural diversity.
It is equally important to note that Health Canada is particularly mindful that much
of the natural health products industry consists of small and medium sized businesses,
and that a sustained effort will be undertaken to provide working tools and processes
to support these enterprises, including initiatives such as the public education
program that will be launched in the fall.
We are confident that the new regulatory framework will be appropriate to this
category of products - one that has enjoyed a long history of safe use. With their
own distinct framework, natural health products can bear a full range of health claims,
based on appropriate levels of evidence. They can also have appropriate good
manufacturing practices that are outcomes-based, which will boost consumer confidence
in the quality and safety of these products. Improved labelling will help consumers
to make informed choices and take more control over their health care decisions.
We would like to take the opportunity to thank our many stakeholders who have invested
considerable time and effort in providing input during the development phase, and we
look forward to continuing our consultative approach in developing guidance documents
in support of the regulations.
Sincerely,
Diane Gorman
Assistant Deputy Minister
Health Products and Food Branch
Health Canada
Phil Waddington
Director General
Natural Health Products Directorate
Health Canada
