January/February 2004 - Ontario College of Pharmacists

New Natural Health
Products Regulations
Greg Ujiye, R.Ph., B.Sc.Phm.
Manager, Pharmacy Practice Programs
T
The new Natural Health Products Regulations
(Regulations) came into force on
January 1, 2004.
The regulation of natural health products
varies internationally. Depending
on the country, these products can be
regulated as drugs, complementary medicines,
therapeutic goods, dietary
supplements or not at all. With the growing
interest in natural health products, it
became apparent to Health Canada that a
review of the regulatory framework was
necessary. (In Canada, natural health products,
also referred to as complementary
medicines or traditional remedies, are subject to
the Food and Drugs Act and Regulations.)
The objective of the review was to ensure a balance
between Canadians’ freedom of choice with respect to
natural health products and the assurance of consumer
safety, while addressing the development of an appropriate
regulatory framework in Canada. This resulted in the
establishment of the Natural Health Products Directorate.
The Regulations were published in June 2003 and came
into force on January 2004 by way of a transitional period
that will span a number of years (two years for site
licensing and six years for products with Drug Identification
Numbers).
The Regulations
The main provisions found in the Natural Health Product
Regulations include: definitions, product licensing, site
licensing, good manufacturing practices, clinical trials,
labelling and packaging requirements, and adverse reaction
reporting. The Regulations fall under the authority of the
Food and Drugs Act, but separate from the Food and Drugs
Regulations.
Definitions
The definitions include the definition of a
natural health product (including, for
example, vitamins, minerals, herbal remedies
and homeopathic medicines) and
other terms which are required for the
purposes of the Regulations.
”Natural health product” means a
substance set out in Schedule 1 or a combination
of substances in which all the
medicinal ingredients are substances set out
in Schedule 1, a homeopathic medicine or a
traditional medicine, that is manufactured, sold
or represented for use in,
(a) The diagnosis, treatment, mitigation or prevention of
a disease, disorder or abnormal physical state or its
symptoms in humans;
(b) Restoring or correcting organic functions in humans; or
(c) Modifying organic functions in humans, such as modifying
those functions in a manner that maintains or promotes
health.
However, a natural health product does not include a substance
set out in Schedule 2, any combination of substances that
includes a substance, set out in Schedule 2 or a homeopathic
medicine or traditional medicine that is or includes a substance
set out in Schedule 2.
Product Licensing System
The product licensing system requires all licensed products
to display a product identification number preceded by the
prefix NPN or, in the case of a homeopathic medicine, by
the letters DIN-HM. The number is issued once a product
is authorized for sale in Canada by the Natural Health Products
Directorate.
Product authorization requires either: i) reference to a
natural health product monograph (published by the
Pharmacy Connection January • February 2004 17