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
- Inspections and the rights and responsibilities of a regulated party
- Zero tolerance for harassment and violence
Health Canada's mandate and authorities
Health Canada is responsible for many acts and 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. They are 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
- 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
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.
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Regulated parties are subject to inspections
A regulated party is anyone in Canada who conducts a regulated activity or possesses a product, article, device or thing that is subject to the laws administered and enforced by Health Canada.
Regulated parties may be:
- drug companies
- sponsors of clinical trials
- retailers, wholesalers, importers and distributors
- individuals or organizations, including businesses
- manufacturers of tobacco products, pesticides, cannabis accessories, radiation-emitting devices and other consumer products
- for example, cribs, strollers, mattresses, toys
What to expect from a Health Canada inspection
A Health Canada inspector has the power to enter any place at any reasonable time where it's believed on reasonable grounds that:
- a regulated activity is being conducted or
- the location contains a regulated product, article, device or relevant document
The inspector may do so 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 an occupant's permission or under the authority of a warrant
- conveyances or means of transport
- for example, cars, trucks, trailers, boats
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, the inspector will identify themselves and produce a certificate of designation to the owner or person in charge of the place being inspected. A metal badge may also be produced.
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 acts and regulations under which an inspection is being conducted, the inspector may observe, measure, test or use other means to verify compliance. For example, the inspector may:
- ask questions to anyone in the place being inspected
- open and examine any container, receptacle or package
- examine any article, product, material, substance or device
- take measurements or photographs and make recordings or sketches
- take samples of articles, products, materials or substances for further analysis
- ask anyone in the place being inspected to produce identification, when inspecting under some acts
- examine electronic data, including viewing, printing, copying or exporting data from any computer system
- examine, copy or photocopy any books, reports, test data, shipping bills, bills of lading, labels, advertising and promotional material or other documents and records (such as inventory records)
During an inspection, the inspector may seize and detain items if:
- they believe these are related to a non-compliance with the acts or regulations under which the inspection is being conducted or
- their purpose is to prevent non-compliance
We expect our inspectors to be reasonable, professional and transparent when carrying out inspections. Inspectors must apply our acts and regulations fairly, consistently and without prejudice and bias. They are also required to follow the Values and ethics code for the public sector as a whole and our own department's code.
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Our inspectors will conduct the inspections in a manner that does not put their safety or that of the regulated party at increased risk.
Inspections and the rights and responsibilities of a regulated party
Regulated parties have certain rights and responsibilities.
Rights of regulated parties
Regulated parties have the right to:
- ask Health Canada inspectors to identify themselves and explain why they are contacting them
- 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. Depending on the program or legislation, there are several mechanisms a regulated party can use to contest an inspection result or process. The inspector's original decision is valid until a re-assessment or re-inspection has been completed.
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Responsibilities of regulated parties
Regulated parties are expected to:
- be prepared to be inspected at any reasonable time
- treat Health Canada inspectors with courtesy and respect
- understand the law as it applies to them (know their legal obligations)
- ensure their products, activities and processes comply with applicable laws
- assist the inspector (includes providing any information the inspector requests)
Zero tolerance for harassment and violence
A respectful work environment is one 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.
We are also taking stronger action to create a safe workplace free from harassment and violence, including sexual harassment and sexual violence, for our employees as a result of:
- changes to the Canada Labour Code, Part II and
- the Work Place Harassment and Violence Prevention Regulations
Federal and provincial human rights laws also prohibit harassment and violence based on identity characteristics such as:
- sex
- age
- race
- colour
- religion
- disability
- 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
- the laws and regulations that apply to them
- for example, the Criminal Code and Health Canada acts
Health Canada has a zero tolerance policy for harassment and violence 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 toward a Health Canada inspector that prevent them from doing their job may result in an obstruction or hindrance charge or other enforcement actions.
Examples of these behaviours include:
- extreme anger, hostility and threatening gestures
- serious or repeated rude, degrading or offensive remarks
- includes put-downs and insults
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