A Guide to Health Canada Inspections
Please also refer to Canada’s approach to onsite inspections during COVID-19: Notice
Health Canada's mandate and authorities
Health Canada is responsible for many acts and their associated regulations that have a direct impact on the health and safety of Canadians.
Health Canada inspectors are designated by the Minister of Health and authorized to conduct inspections of regulated parties to monitor and verify compliance with the following laws:
- Assisted Human Reproduction Act;
- Canada Consumer Product Safety Act;
- Cannabis Act;
- Controlled Drugs and Substances Act;
- Department of Health Act;
- Food and Drugs Act;
- Hazardous Products Act;
- Pest Control Products Act;
- Pesticide Residue Compensation Act;
- Radiation Emitting Devices Act; and
- Tobacco and Vaping Products Act.
A full list of the Acts and Regulations administered by Health Canada.
The following sections describe, in a general manner, the practices for Health Canada inspections across all Health Canada's Acts and Regulations. It is not intended to substitute for, supersede or limit the requirements under each applicable Act. In case of any discrepancy between this summary and the legislation, the legislation prevails. Each Act can be consulted for the full scope of an inspection as it applies to that specific Act.
Who is subject to inspections by Health Canada inspectors?
Anyone in Canada who conducts an activity or possesses a product, article, device, or thing that is subject to the laws administered and enforced by Health Canada becomes a regulated party. A regulated party under the laws outlined above may be subjected to an inspection by Health Canada. Regulated parties may be, but are not limited to:
- Individuals or organizations (including businesses);
- Retailers, wholesalers, importers, and distributors;
- Manufacturers of tobacco products, pesticides, cannabis accessories, radiation emitting devices, and other consumer products (e.g., cribs, strollers, mattresses, toys, etc.);
- Drug companies; or
- Sponsors of clinical trials.
What to expect from a Health Canada inspection?
In general, to verify compliance or to prevent non-compliance with the applicable laws, a Health Canada inspector has the power to enter any place or premises at any reasonable time where it is believed on reasonable grounds that a regulated activity is being conducted or in which a regulated product, article, device, or thing or relevant document is located. As provided by the particular Act(s) and Regulations, the places a Health Canada inspector may enter while conducting an inspection, may include, but are not limited to:
- Places of business of a manufacturer (e.g., offices, factories, warehouses);
- Places of business of a seller or distributor (e.g., storefronts, storage areas, hospitals, pharmacies);
- Personal residences (i.e., "dwelling-house"), with permission of an occupant or under the authority of a warrant; or
- Conveyances or means of transport (e.g., a car, truck, trailer, boat, etc.).
An on-site inspection may be either unannounced or scheduled in advance with the regulated party.
By law, an inspector must be granted access to enter and permitted access to all of the applicable areas of the site being inspected. Upon request, a Health Canada inspector will identify himself or herself and produce a certificate of designation to the owner or person in charge of the place being inspected. This may be supplemented by a metal badge. Anyone at the place of the inspection is legally required to give the inspector all reasonable assistance and provide the inspector with any information that the inspector may require during the inspection. It is important to remember that it is illegal to obstruct or hinder, or knowingly make any false or misleading statement (orally or in writing), to an inspector while the inspector is carrying out his or her duties.
In some circumstances, a Health Canada inspector may conduct an inspection remotely (e.g., via a live video feed, an electronic request such as an e-mail).
The inspector verifies compliance with the applicable requirements set out in the applicable laws, standards, and any licences, permits, or other authorizations, based on the facts collected through observation, measurement, testing, or other means. Depending on the Act(s) and Regulations under which an on-site inspection is being conducted, the activities that a Health Canada inspector may perform include, but may not be limited to:
- Examining any article, product, material, substance, or device;
- Opening and examining any container, receptacle, or package;
- Examining, copying, or making copies of any books, documents, reports, test data, shipping bills, bills of lading, labels, advertising and promotional material, or other records (e.g., inventory records);
- Examining electronic data, including viewing, printing, copying, or exporting data from any computer system;
- Taking samples of articles, products, materials, or substances for further analysis;
- Taking measurements or photographs and make recordings or sketches;
- Requesting that anyone in the place being inspected establishes his or her identity by producing identification, when inspecting under some Acts; and
- Asking questions to anyone in the place being inspected.
During the inspection, Health Canada inspectors may seize and detain items, such as those that he or she reasonably believes are related to a non-compliance of the Act(s) or Regulations under which the inspection are being conducted, or for the purpose of preventing non-compliance.
Health Canada's Acts or Regulations are applied in a fair, consistent, and impartial manner. Health Canada inspectors are expected to carry out their activities in ways that are reasonable, professional, transparent, unbiased, and unprejudiced and to follow the Values and Ethics Code for the Public Sector and the Health Canada Values and Ethics Code at all times. Health Canada inspectors will conduct the inspections in a safe manner that does not put either themselves or the regulated party in a position where their safety is at an increased risk.
What are regulated parties' rights and responsibilities before, during, and after an inspection?
Health Canada expects regulated parties to behave in an honest, respectful, and ethical manner, and to act in good faith in all interactions with Health Canada inspectors.
Rights of Regulated Parties
Regulated parties have the right to:
- Require that Health Canada inspectors identify themselves and explain why they are contacting the regulated party;
- Discuss their rights and responsibilities with the inspector;
- Ask questions or ask for clarification on any aspect of the inspection process or the laws that apply to them;
- Be advised of results of the inspection, including any reasons for an inspector's decisions;
- Communicate with and receive information in either official language (English or French), as set out by the Official Languages Act;
- Obtain information under the provisions of the Access to Information Act; and
- Have any personal information protected, as set out by the Privacy Act.
A regulated party may contest an inspector's decision relating to an inspection. Depending on the particular program or legislation, there are several mechanisms available to a regulated party to document any concerns over an inspection result or process. However, the original decision made by the inspector will remain valid until a re-assessment/re-inspection has been completed.
Responsibilities of Regulated Parties
Regulated parties are expected to:
- Understand the law as it applies to them (i.e., know your legal obligations);
- Ensure their products, activities, and processes comply with applicable laws;
- Treat Health Canada inspectors in a courteous and respectful manner;
- Give the inspector assistance and provide the inspector with any information requested; and
- Be prepared to be inspected at any reasonable time.
Health Canada has a zero tolerance policy for violence and harassment in the workplace that extends to our inspectors before, during, and after an inspection. Physical violence and threatening or abusive remarks (oral or written, including messages via e-mail or social media) directed toward a Health Canada employee will be reported to law enforcement and may be met with legal action. Any other behaviour (e.g., extreme anger, hostility, threatening gestures; serious or repeated rude, degrading or offensive remarks, put-downs or insults) directed toward a Health Canada inspector that prevents an inspector from carrying out his or her duties may also result in an obstruction or hindrance charge or other enforcement actions.
Where do I go for more information?
More information about Health Canada and the services provided by Health Canada are available online.
Additional information about the legal requirements and compliance and enforcement programs is also available online by visiting:
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