Inspector Roles Under the Food & Drugs Act

Whether you are importing health products into Canada or preparing to import, the latest policies on Health Canada inspectors and their rights offer valuable insight into compliance and enforcement programs under the Food & Drugs Act.

The inspection provisions in the Act are designed to protect consumers who are vulnerable to risks posed by unauthorized health products and misleading advertising. Under the Act, inspectors have powers to verify compliance with the Act and regulations. Policies published in March 2021 explain the general circumstances where an inspector might issue an order and cover the rights and responsibilities of inspected parties.

Inspectors under the Act have two main goals: to verify compliance and to prevent non-compliance. Section 22.1(1) of the Act gives authority to an inspector to issue an order. This order may require regulated parties to provide documents, information or product samples to assist the inspector’s assessment of compliance. The Policy on Inspector Orders for Health Products (POL-0139) provides full details on Health Canada’s expectations for co-operation with inspectors. An order to provide information is not limited to regulated parties. Organizations or individuals who are not regulated under the Act but may have information concerning a regulated health product may be ordered to assist inspectors by providing product samples or related documentation.

Remote access to a site is included in the scope of inspections. The Policy on Accessing the Premises of a Regulated Party Remotely to Verify Compliance (POL-0138) can be consulted for further information on telecommunication strategies in use such as telephone, video calling or other web-based systems.

Importers should be prepared for inspections or document requests at any time, once required licenses are in place from Health Canada. Records should be available at the site to support compliance with the Food & Drugs Act and associated regulations. Implementing and maintaining a pharmaceutical quality system that incorporates Good Manufacturing practices will reduce the likelihood of removal of products from the premises, refusal of products at the border or cancellation of licenses due to non-compliance with Canadian regulations for drugs and natural health products.