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.
Activities
Covered by the Natural Health Products Regulations
A product
licence is required for each natural health product sold in
Canada
.
A site
licence is required in order to manufacture, package, label, and import for
sale a natural health product.
Laboratories
A
laboratory that conducts additional activities outside of solely testing a
natural health product, namely manufacturing, packaging, labeling, importing or
distributing, is required to obtain a site licence.
Note:
A laboratory that solely tests a natural health product is not required
to obtain a site licence.
For
example, a manufacturer, packager, labeler or importer may contract a laboratory
to perform testing on a natural health product. Manufacturers, packagers,
labelers and importers are encouraged to contract laboratories that follow good
laboratory practices.
3.1 Manufacturing
A
manufacturer is a person who fabricates or processes a natural health product
for the purpose of sale. The site licence provisions apply to manufacturers of
natural health products. These provisions include requirements for product
specifications, premises, equipment, personnel, sanitation, operations, quality
assurance, product stability, record keeping, product sterility, ophthalmic use,
lot or batch samples and recall reporting.
3.2 Packaging
The
site licence provisions apply to companies packaging natural health products.
3.3 Labeling
The
site licence provisions apply to companies labeling natural health products.
3.4
Importing for
Sale
in
Canada
An
importer is a person who imports a natural health product into
Canada
for the purpose of sale. The site licence provisions apply to importing.
Direct Sellers
In
the case of direct sellers who may receive imported products directly from a
parent company located in or outside of
Canada
, the parent company representing the direct seller is required to obtain a site
licence. If the parent company is located outside of
Canada
, it must have a site in
Canada
and it must obtain a site licence for this site. If the parent company is
located in
Canada
, it must obtain a site licence for this site. The onus is on the direct
seller's parent company to maintain all necessary documents to allow for
complete recall of a product. Independent direct sellers are not considered
distributors and, as a result, do not have to meet good manufacturing practices
or obtain a site licence.
Foreign Sites
Canadian
importers must be licensed and the onus is on them to provide evidence that
imported products come from sites that meet Canadian good manufacturing
practices under Part 3 of the Natural Health Products Regulations, or equivalent
standards.
One
of the following types of evidence is required from importers with respect to
the foreign sites:
Note:
Establishment licence holders who are also importers and have foreign sites that
are not listed on their licence should submit evidence as defined above.
It
is the responsibility of the importer to ensure that the reports submitted to
NHPD are complete and that all requirements of the Good Manufacturing Practices
are being met. Supplementary information may be requested.
Clinical
Trials
For
clinical trials to import means to import a natural health product into
Canada
for the purpose of sale in a clinical trial. The clinical trial sponsor must
submit to NHPD information about the sponsor's representative in
Canada
who is responsible for the sale of the natural health product.
3.5
Distribution
A
distributor is a person who sells a natural health product to another person for
the purpose of further sale by that other person. This definition includes
wholesalers, whose name and address are usually not on a product label. This
definition does not include independent direct sellers.
Good
manufacturing practices apply equally to distributors and wholesalers whether or
not the company name appears on the label; however, distributors and wholesalers
do not need to obtain a site licence..
3.6
Clinical Trials Involving Humans
A
clinical trial is an investigation of a natural health product that involves
human subjects and that is intended to discover or verify the product's
clinical, pharmacological or pharmacodynamic effects, to identify any adverse
events that are related to its use, to study its absorption, distribution,
metabolism and excretion, and to ascertain its safety or efficacy. The clinical
trial sponsor is responsible for applying for clinical trial approval from NHPD,
and research ethics approval from an independent research ethics board.
The
Natural Health Products Regulations set out obligations for the clinical trial
sponsor, which include good clinical practices, product labeling, record
keeping, information and samples submission, and adverse reaction reporting. The
site licence provisions do not apply to clinical trials, and sponsors are not
required to have a site licence to conduct a clinical trial. Health
Canada
inspects clinical trial sites for compliance with good clinical practices. A
Clinical Trials Guidance Document will be developed.
3.7
Adverse Reaction Reporting
Health
Canada
's adverse reaction reporting system sets out the requirements for monitoring
and reporting adverse reactions associated with the use of natural health
products. This reporting system is an important part of the product review
system, which is based on risk assessment and the corresponding management of
risks.
Product
licence holders are required to provide Health
Canada
with information about any serious adverse reactions and any serious unexpected
adverse reaction to their products.
Clinical
trial sponsors must also report to Health
Canada
any serious adverse reactions and any serious unexpected adverse reactions to
the natural health product that have occurred inside
Canada
.
