Canadian Product Licenses for Dietary Supplements.

Date: Thursday, July

16th, 2015 || Time: 01:00 PM EDT | 10:00 AM PST

Duration: 60 Minutes || Course Level: Intermediate

'Live' Webinar by

Karen Friedman

Register Now

Overview
The webinar will contain an overview of product licence applications that are required in
Canada for dietary supplements (called natural health care products) as per the
Canadian Natural Health Products Regulations. An explanation of which products are
covered by these regulations and which products are exempt will be provided. The
definition of a natural health product will be reviewed, with close attention provided on
details such as acceptable dosage forms and package claims. The difference between
this unique group of products and other regulated products, such as cosmetics, over-thecounter drugs and foods will be discussed.
Examination of the different types of product licence applications that must be submitted
before marketing of dietary supplements to Canadians. The necessary components of
various application types will be covered. Examples will be provided using Health
Canadas electronic application forms, and using case studies of acceptable applications
and applications that would likely be refused.
A site licence is also required to be in place before dietary supplements are exported and
sold in Canada and a brief explanation of this part of the approval process will be
provided.
Why Should You Attend
Confusion remains for those foreign companies wishing to sell their dietary supplements
in Canada. Often these groups are left wondering just how to steer through the
regulations governing the sale of their supplements in Canada. Unlike other countries in
the world, Canada requires all manufacturers to conform to specific regulations (called
the Natural Health Products Regulations) for their dietary supplements before exporting
these for sale in Canada.
For dietary supplements, termed Natural Health Product in Canada, each product must
receive a product licence before it is sold in Canada, as evidenced by an 8-digit NPN
confirming approval by Health Canada. Once these application processes are fully
understood the result will be a reduction in delays experienced when exporting dietary
supplements to Canada.

Companies who have experienced refused shipments at the Canadian border or

products removed from shelves in Canada will gain awareness around the reasons for
this, and receive tools to avoid this occurrence in the future. Marketing groups will gain
clarity on permissible package claims and advertising statements in Canada for dietary
supplements.
Health Canadas seal of approval is a pre-requisite for sale of dietary supplements and is
displayed on all approved packages. The government endorsed supplements are sought
out by the more informed Canadian consumers. A solid appreciation of the Canadian
marketplace, application process and competitor products in the various categories of
consumer health products is fundamental to the successful product launch in Canada.
Areas covered in the webinar
Introduction into Natural Health Product (dietary supplement) category
Comparison of this category with other regulated product categories in Canada
Review of reasons for regulating dietary supplements
Differences between natural health products (supplements) and foods
Examination of different type of applications for dietary supplements
Discussion of necessary components of product licence applications
Health Canada guidance documents for applicants
Finished product release requirements
Review of safety warning labels for dietary supplements in Canada.
Discussion on advertising of FDA dietary supplements in Canada
Brief review of paper-free product licence applications for dietary supplements
Overview of responsibilities for licence holders of dietary supplements during licence
and post-licence
Distinction between product licence holder, importer and manufacturer
Learning objective
How to secure a product licence for dietary supplement and other natural health products
for your product in Canada.
Who will benefit

Manufacturers of dietary supplements for sale in Canada.

Manufacturers of consumer health products for sale in Canada.
Exporters of dietary supplements for sale in Canada.
Quality affairs consultants
Regulatory affairs consultants
Product development and formulation departments
Marketing groups for dietary supplement sales
International sales departments.

Speaker profile
Karen Friedman, MSc., is president of K Friedman Consulting, a
Canadian consulting firm providing regulatory affairs and quality affairs
services for natural health products, cosmetics, foods and drug products.
Karen Friedman has over 20 years of regulatory affairs experience in
Canada and has worked for major Canadian pharmaceutical and
consumer goods companies. K Friedman Consulting delivers regulatory guidance on
foreign facility compliance, product compliance and product development strategies for
health-related products intended for Canada.K Friedman Consulting is a member of
RAPS and CAPRA [Canadian Association of Professional in Regulatory Affairs].