Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Karen Friedman
OVERVIEW:
An introductory overview will begin the webinar providing tools for clarifying the different types of consumer health products available and regulated in Canada, including drugs, cosmetics, natural health products and health foods. This introduction will include a brief discussion on the acceptable package claims for each type of product, and permissible label statements.
A brief discussion will be provided summarizing the different types of applications required before marketing each type of consumer health product in Canada.
The importation of each product and regulations governing the importation will be examined, with detail provided on Canadian importer responsibility and supply chain logistic recommendations for those wishing to export their health products to Canada.
An outline of responsibilities of health product license holders and distributors of consumer products to Canada will be provided. Post approval responsibilities for each product type will be summarized.
A review of adverse event reporting responsibilities for market authorization holder of consumer health products will be provided. Key requirements of advertising material, and product recall management advice will be provided for different product types.
New changes to consumer health product regulations will be discussed with respect to their importance for product license holders and exporters of health foods and health products to Canada.
The latest regulations in Canada implemented to protect Canadians from unsafe drugs will be discussed with attention to products covered and responsibilities of license holders, manufacturers and importers.
Why should you attend: Applicants outside of Canada who intend to register health products and foods in Canada are often bewildered by the numerous regulations in place. The classification of a product itself can take time away from a project and cause delays in the approval queue, sending an applicant back to square one if this is done incorrectly.
Additionally, the regulations governing the sale and marketing of foods, drugs and cosmetics are updated continuously in Canada due to revisions in the Acts and their regulations, availability of new guidelines and forms, and staffing and resource changes at the federal level.
The first step in registering any consumer product (health products and foods) is to understand which category your product belongs to under the Canadian regulations, and which type of application needs to be filed before marketing the product.
Proper planning up front will save time, money and headaches when planning to launch your consumer health product in Canada.
After completion of the seminar, participants will be able to quickly and easily understand how their food products, cosmetics, drugs, dietary supplements and other consumer health products are regulated in Canada, and identify the support needed to move these products into Canada without delay.
The post license portion of the consumer product life cycle is a new and ongoing concern for exporters and marketers of consumer health products in Canada. All manufacturers and marketers need to fully understand the newly passed legislation in Canada, Vanessa’s Law, instituted to protect Canadians from unsafe drugs.
Areas Covered in the Session:
– Category assignment for consumer health products regulated in Canada, including:
– Health food and health supplements
– Drugs
– Natural Health Products
– Cosmetics
– Permissible claims for each type of consumer health product
– Application types in Canada for each consumer health product
– Navigation through Health Canada’s website
– Tips on communicating effectively with Health Canada
– Distinction between manufacturers and license holders
– Post licence and post market responsibilities for exporters, license holders
– Vanessa’s law and its implications
– Health products and food regulatory modernization in CanadaHealth Products Regulation changes for consumer health products- how to find them, updates, RSS feeds
– Health Canada’s standard labels for dietary supplements and how to use them
– Use of Health Canada’s guidance documents
– Licensed product databases
– Product recall guidance for consumer health products
– Introduction to Marketed Health Products Directorate of Canada
Who Will Benefit:
– Regulatory Affairs
– Quality Affairs
– Product Development Departments – Food, Drugs and Cosmetics
– Marketing and Sales for Food Supplements
– Marketing and Sales for Cosmetics
– Marketing and Sales for Dietary supplements
– Compliance Groups
– Export Associations
– 3rd party Logistics Groups
– Supply Chain Management for Pharmaceuticals and Dietary Supplements
– Third Party Laboratories and Packagers
– Contract Manufacturers of Dietary Supplements
– Contract Llabelling and Contract Packaging organizations for Dietary Supplements, Drugs and Cosmetics
SPEAKER PROFILE:
Karen Friedman (K Friedman Consulting), provides specialized regulatory affairs guidance for drug products, natural health products, foods and cosmetics intended for the Canadian market. Services include product and label compliance management, quality assurance leadership, and supply chain management.
K Friedman consulting has helped Canadian and international companies of all sizes successfully steer through the regulatory mazes that govern the sale of health products in Canada, enabling clients to get their products into Canadian without delay. Typical clients include raw material and finished product manufacturers, packagers and labellers of consumer health products and dietary supplements, Canadian importers and non-Canadian suppliers to Canada of dietary supplements and natural health products, third party logistic groups and distributors.
