Exporting your Dietary Supplements to Canada

Overview:

Detailed overview of product license applications required for sale of dietary supplement products in Canada. For dietary supplements the requirements list set out by the Natural Health Product Directorate of Health Canada must be followed to a 't'. Any incomplete applications will be refused.

Topics under product application section will include the definition of a natural health product (also termed dietary supplement), coverage of which products may qualify and which products are exempt from the regulations, the various types of other consumer products covered under these regulations, and the types of applications that must be filed and approved before these consumer products are sold in Canada.

Additional topics include product label discussion layout of the label information, location of information, requirements for safety statements, manufacturers address/importers address, brief review of language requirements.

Regulatory strategy will be covered off for those products that are on the food/supplement border and those products on the supplement/cosmetic border - the specific requirements and allowance for each will be touched on with respect to permitted ingredients and label statements.

The timeframes for application preparation and review by Health Canada will also be covered.

Supply chain logistics for all facilities involved in bringing dietary supplements into Canada will be examined including discussions on license types and license application requirements for new and currently approved facilities.

Future directions of facility licensing in Canada will be addressed.

Why should you Attend: Confusion remains for those foreign companies wishing to export their dietary supplements to Canada. Often these groups are left wondering just how to steer through the regulations governing the import and sale of these products across the border. Unlike other countries in the world, Canada requires all manufacturers to adhere to specific regulations (called the Natural Health Product Regulations) for their dietary supplements before exporting these to Canada.

For dietary supplements, termed Natural Health Product in Canada, there are two types of licenses that must be in place before their sale; a site license and a product license Webinar participants who wish to export their products to Canada will be able to do so with minimal delay by grasping the differences between these two types of licenses and what's required to obtain each from Health Canada. Once these application processes are mastered the result will be a reduction in the delay to 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 Canada's 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 processes and competitor products in the various categories of consumer health products is fundamental to the successful Canadian product launch.

After completion of the seminar, participants will be able to quickly and easily understand how their dietary supplement and other consumer health products are regulated in Canada, and identify the support needed to move these products into Canada without delay.

Areas Covered in the Session:

• Introduction into Natural Health Product (dietary supplement) category
• Comparison of this category with other regulated product categories in Canada
• Review of history of regulations for dietary supplements (NHPR)
• Examination of different type of applications for dietary supplements
• Discussion of necessary components of product licence applications
• Review of permissible package labels for dietary supplements in Canada
• Discussion on advertising of dietary supplements in Canada
• Brief review of paper-free product licence applications for dietary supplements
• Overview of responsibilities for licence holders of dietary supplements
• Canadian Good Manufacturing Practices for Natural Health Products
• Guidance on facility requirements for foreign facilities manufacturing dietary supplement for export to Canada
• Advice on preparing and submitting applications for facilities involved in manufacturing, packaging, labelling, testing and exporting of dietary supplements to Canada

• Regulatory Affairs
• Quality Affairs and Quality Control
• Product Development and Formulation Departments
• Marketing & Sales
• International Sales Departments
• Compliance Directors
• Export Associations
• 3rd Party Logistics
• Supply Chain Management for Pharmaceuticals and Dietary Supplements
• Third Party Laboratories
• Third Party Packagers
• Contract Manufacturers of Dietary Supplements and their Ingredients
• Contract Labelling and Contract Packaging organizations for Dietary Supplements