Health Canada’s Enforcement of the Regulatory Requirements for the Manufacture, Advertising and Sale of Pharmaceuticals, Medical Devices and Natural Health Products

Why Should You Attend:

This advanced webinar will offer guidance for all companies involved in the manufacture, advertising and sale of pharmaceuticals, medical devices and natural health products (including external advisors and consultants) that do business, or want to do business, in Canada.

These companies should be aware of Health Canada’s approach to enforcement, and the penalties for being found offside Canadian rules and regulations so appropriate business decisions can be made. With the introduction of Vanessa’s law in late 2014, the landscape has changed significantly. There is now the possibility of significantly higher penalties and other enforcement measures, including the disclosure of confidential business information.

An error can be costly: Health Canada’s enforcement provisions include the ability to impose strict penalties and jail time (higher now, with the introduction of Vanessa’s law), order a stop sale and/or product recall. This course will illustrate why the cost of doing business is becoming increasingly high and why it is essential for businesses to be aware of the rules of the game.

Areas Covered in the Webinar:

• Introductions: the regulator and relevant legislation
• Health Canada and the Inspectorate
• The Food and Drugs Act and its Regulations
• Vanessa’s Law – overview of new law and its potential impact on industry
• Compliance: Canadian requirements for the manufacture, advertising and marketing of pharmaceuticals, medical devices and natural health products
• Compliance monitoring, verifications and investigations
• Enforcement, and regulatory measures to ensure compliance

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in any pharmaceutical, medical device or natural health product company that advertises or markets product in Canada, including:

• Regulatory affairs
• Marketing
• Business Development
• Legal department
• External consultants who advise pharmaceutical or medical device companies

Instructor Profile:

Sara Zborovski is a partner at the law firm of Davis LLP in Toronto. She assists companies regulated by Health Canada and the FDA obtain market access and in all areas of compliance.

Ms. Zborovski works with companies to get products from idea to market, and provides strategic advice on: compliance strategies, including advertising and marketing programs (including label review), pharmaceutical marketing and pricing requirements (including matters relating to provincial formulary listing), compliance programs relating to manufacturing and import (establishment licensing, GMP programs, post-market reporting obligations, and packaging), and intellectual property issues. She advises clients on federal and provincial privacy laws, particularly as these relate to the healthcare space, and federal and provincial access to information and freedom of information matters.

Ms. Zborovski also works with clients in all industries in matters relating to product safety, including crisis management, advocacy before the Inspectorate and product recalls.

Topic Background:

Health Canada takes an active role in ensuring the safety and efficacy of health products (pharmaceuticals, medical devices and natural health products) in Canada. Working together with other levels of government, health care professionals, patient and consumer interest groups, research communities and manufacturers, the agency department endeavours to minimize the health risk factors to Canadians and maximize the safety provided by the regulatory system for these products.

The Health Products and Food Branch Inspectorate delivers the national compliance and enforcement program for health products. The Inspectorate monitors the activities of industry to ensure compliance with the regulatory system. When potential issues are identified, the Inspectorate will work with the responsible party and/or take the necessary enforcement actions to minimize the risk to health and safety.

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