A Guide to Health Canada Inspections
On this page
- Health Canada’s mandate and authorities
- Regulated parties are subject to inspections
- What to expect from a Health Canada inspection
- Rights and responsibilities of a regulated party before, during and after an inspection
- Zero tolerance for harassment and violence
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 people living in Canada.
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:
- Cannabis Act
- Food and Drugs Act
- Hazardous Products Act
- Pest Control Products Act
- Department of Health Act
- Radiation Emitting Devices Act
- Tobacco and Vaping Products Act
- Assisted Human Reproduction Act
- Canada Consumer Product Safety Act
- Controlled Drugs and Substances Act
- Pesticide Residue Compensation Act
The following sections summarize the Health Canada inspection process. Our authority to inspect does not replace, supersede or limit the requirements under each applicable act.
If there is any discrepancy between this summary and the legislation, the legislation prevails. Each act may be consulted for the full scope of an inspection as it applies to that specific piece of legislation.
Regulated parties are subject to inspections
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. Health Canada may inspect a regulated party under the laws listed above . Examples of regulated parties may be:
- individuals or organizations, including businesses
- retailers, wholesalers, importers and distributors
- manufacturers of tobacco products, pesticides, cannabis accessories, radiation-emitting devices and other consumer products
- for example, cribs, strollers, mattresses, toys
- drug companies
- sponsors of clinical trials
What to expect from a Health Canada inspection
A Health Canada inspector has the power to enter any place or premises at any reasonable time where it’s believed on reasonable grounds that:
- a regulated activity is being conducted or
- a regulated product, article, device or thing or relevant document is located
The inspector may do so at any reasonable time to verify compliance or to prevent non-compliance with the applicable laws.
Examples of places that a Health Canada inspector may enter include:
- a manufacturer’s place of business
- for example, offices, factories, warehouses
- a seller or distributor’s place of business
- for example, retail areas, storage areas, hospitals, pharmacies
- personal residences , such as a “dwelling-house ”, with permission of an occupant or under the authority of a warrant
- conveyances or means of transport
- for example, a car, truck, trailer, boat
An inspector may enter a place physically or access it remotely using telecommunications (for example, through a live video feed). The inspector may do so unannounced or schedule the inspection in advance with the regulated party.
By law, an inspector must be allowed to enter the site and given access to all of the areas being inspected. Upon request, a Health Canada inspector will identify themselves 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 site being inspected is legally required to give the inspector all reasonable assistance and provide any information that the inspector requests. It is illegal to obstruct or hinder an inspector while they are carrying out their duties. It is also illegal to knowingly make a false or misleading statement (orally or in writing).
The inspector will verify compliance with the requirements set out in the applicable laws, standards and any licences, permits or other authorizations.
Depending on the act(s) and regulations under which an inspection is being conducted, the inspector may observe, measure, test or use other means to verify compliance. For example, they may:
- examine any article, product, material, substance or device
- open and examine any container, receptacle or package
- examine, copy or make copies of any books, documents, reports, test data, shipping bills, bills of lading, labels, advertising and promotional material or other records (such as inventory records)
- examine electronic data, including viewing, printing, copying or exporting data from any computer system
- take samples of articles, products, materials or substances for further analysis
- take measurements or photographs and making recordings or sketches
- request that anyone in the place being inspected establishes their identity by producing identification, when inspecting under some acts
- ask questions to anyone in the place being inspected
During an inspection, the inspector may seize and detain items if:
- they reasonably believe these are related to a non-compliance with the acts or regulations under which the inspection is being conducted or
- the purpose is to prevent non-compliance
Health Canada's acts and regulations are applied in a fair, consistent and impartial manner. We expect our inspectors to be reasonable, professional, transparent, unbiased and unprejudiced when carrying out inspections. They are also required to follow the Values and Ethics Code for the Public Sector and the Health Canada Values and Ethics Code at all times.
Our inspectors will conduct the inspections in a manner that does not put their safety or that of the regulated party at increased risk.
Rights and responsibilities of a regulated party before, during and after an inspection
Regulated parties are expected to behave honestly, respectfully and ethically, and to act in good faith when dealing with a Health Canada inspector.
Rights of regulated parties
Regulated parties have the right to:
- ask Health Canada inspectors to 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 about the inspection process or the laws that apply to them
- know the results of the inspection, including reasons for an inspector’s decision
- 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
- 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 program or legislation, there are several mechanisms available to a regulated party for documenting concerns about an inspection result or process. The inspector’s original decision is valid until a re-assessment or re-inspection has been completed.
Responsibilities of regulated parties
Regulated parties are expected to:
- understand the law as it applies to them (know their legal obligations)
- ensure their products, activities and processes comply with applicable laws
- treat Health Canada inspectors with courtesy and respect
- assist the inspector (includes providing any information the inspector requests)
- be prepared to be inspected at any reasonable time
Zero tolerance for harassment and violence
We all share an obligation to maintain a respectful work environment that is free of discrimination, harassment and violence. Health Canada is committed to providing a work environment where everyone, including our regulated parties, is treated with respect and dignity.
The Government of Canada has recently amended the Canada Labour Code, Part II, and has passed the Work Place Harassment and Violence Prevention Regulations. As a result, Health Canada is taking stronger action to create a safe workplace free from harassment and violence, including sexual harassment and sexual violence, for our employees.
Federal and provincial human rights laws also prohibit harassment and violence based on identity characteristics such as:
- sexual orientation
- national or ethnic origin
- gender identity or expression
We expect regulated parties to treat our inspectors in accordance with these shared values and with the laws and regulations that apply to them. This includes the Criminal Code and the applicable Health Canada act(s).
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. The following behaviours will be reported to law enforcement and legal action may be taken:
- physical violence
- threatening or abusive remarks
- oral or written, including messages sent by email or posted on social media
Other behaviours directed towards a Health Canada inspector that prevents them from carrying out their duties may result in an obstruction or hindrance charge or other enforcement actions, including:
- extreme anger, hostility and threatening gestures
- serious or repeated rude, degrading or offensive remarks
- includes put-downs and insults
- Health Canada’s acts and regulations
- Compliance and enforcement: Drugs and health products
- Compliance and monitoring of controlled substances and precursor chemicals
- Consumer products and cosmetics
- Regulating tobacco and vaping products
- Pesticides compliance and enforcement
- Compliance and enforcement of cannabis
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