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Main
Components of the Natural Health Products Regulations
The following
information is an excerpt from the
Overview
of the Natural Health Products
Regulations
Guidance Documents of the Natural
Health
Products Directorate (NHPD) of Canada.
The Natural
Health Products Regulations set out requirements for manufacturing,
packaging, labeling, storing, importation for sale, distributing and selling
natural health products, as well as clinical trials involving humans.
It is the sale of
natural health products for the purposes of manufacturing, packaging, labeling,
distributing, importing, and use in clinical trials that is captured by these
Regulations, not the sale of natural health products by retailers.
4.1 Product
Licensing
Part 1
(Product Licenses) of the Natural
Health Products Regulations sets out requirements for product licensing
and the responsibilities of the product licence holder. The Regulations require
an individual to obtain a product licence prior to selling an NHP in
Canada.
See the following
guidance documents for more information:
 | Product
Licensing Guidance Document
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| Evidence
for Quality of Finished Natural Health Products
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| Evidence
for Safety and Efficacy of Finished Natural Health Products
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| List
of Acceptable Non-medicinal Ingredients
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| Compendium
of Monographs
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| Homeopathics
Guidance Document
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| The
Adverse Reaction Reporting Guidance Document-For Health Care Providers and
Consumers
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4.2 Site Licensing
Part 2
(Site Licenses) sets out the requirements for site
licensing and the responsibilities of a site licence holder. A site licence is
required for manufacturers, packagers, labelers and importers of natural health
products.
See the Site Licence
Guidance Document for more information.
4.3 Good
Manufacturing Practices
Part 3
(Good Manufacturing Practices) sets out good
manufacturing practices - measures designed to ensure an effective overall
approach to product quality control and risk management. They do so by setting
appropriate standards and practices for product testing, manufacturing, storage,
handling and distribution. The Good Manufacturing Practices Guidance Document
outlines the requirements in detail for the manufacturing, packaging, labeling,
importing and distributing of natural health products.
See the Good
Manufacturing Practices Guidance Document for more information.
4.4 Clinical Trials
Part 4
(Clinical Trials) of the Natural
Health Products Regulations covers clinical trials of natural health
products involving humans. The requirements for clinical trials are designed to
protect the rights, safety and well-being of clinical trial participants and
other persons involved in conducting and evaluating clinical trials. The site
licence provisions of the Regulations do not apply to clinical trial sites, but
the sponsor who conducts the clinical trial must meet all the requirements set
out in Part 4.
See the Clinical
Trials Guidance Document for more information.
4.5 Labeling and
Packaging
Part 5
(Labeling and General) sets out the requirements
for labeling and packaging natural health products.
See the Product
Licensing Guidance Document for more information
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