Compliance and Enforcement Policy (POL-0001)

From: Regulatory Operations and Enforcement Branch (ROEB)


As part of its regulatory responsibilities, Health Canada monitors compliance, undertakes enforcement activities and works towards preventing non-compliance with the legislation that Health Canada administers. This policy describes Health Canada’s national compliance and enforcement approach for health products regulated under the Food and Drugs Act and its regulations.

Important notice

It has become increasingly important to have a strong and dynamic compliance and enforcement function to protect Canadians’ health through modern legislation and effective compliance and enforcement actions supported by strong border oversight and international cooperation.

Who this guide is for

Anyone conducting a regulated activity under the Act has prescribed responsibilities for the safety, efficacy and quality of health products to be sold in Canada. Other parties may also be subject to the Act although they may not require an authorization from Health Canada to perform certain activities.

As new health products and activities emerge and become regulated under the umbrella of the Act and its regulations, this policy will apply to the oversight of these products and activities.


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Details and history

For assistance

Regulatory Operations and Enforcement Branch
Jeanne Mance Building
200 Eglantine Driveway, 7th Floor
Address Locator 1907A
Tunney's Pasture
Ottawa, Ontario K1A 0K9

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