Monitoring health products on the Canadian market

Learn more about how we monitor the compliance of health products on the market.

How we monitor compliance

Health Canada is responsible for helping people in Canada maintain and improve their health. Our compliance and enforcement activities help protect you against health and safety risks.

In Canada, health products must meet legislative and regulatory requirements to be legally sold. These requirements are outlined in the Food and Drugs Act and its regulations. For example, a product licence is required for:

drugs
natural health products (NHPs)
medical devices (except Class I devices)

When we issue a licence, it means we have reviewed the safety, efficacy and quality of the product before it goes to market.

Companies must also meet requirements when they perform certain activities related to health products.

For example, a licence is required to:

fabricate, package, label, distribute, import, wholesale or test a drug (drug establishment licence)
fabricate, import, package or label a natural health product (site licence)
with some exceptions, fabricate, sell or import medical devices (medical device establishment licence)

We monitor the compliance of health products on the market in different ways.

One way we do this is through proactive compliance monitoring projects, where inspectors may check that health products:

don't pose a risk to health
contain what they say they should
list necessary information on their label
are licensed for sale in Canada (if a licence is required)
make only health claims that they're authorized to make (called terms of market authorization)

Inspectors may also verify that a regulated party's activities are conducted in accordance with relevant requirements.

Compliance monitoring projects complement our complaint-based verifications and routine inspection programs for health products. Through these projects, we can gather more information on specific issues or use them as an opportunity for compliance promotion. Many regulated parties involved in our compliance monitoring projects use them as a chance to clarify the requirements to follow them better.

How we select products and activities for compliance monitoring

Compliance monitoring projects are usually focused on specific types of products or activities. For example, we may choose a product that has had an increasing number of complaints or an activity that can have a large impact on product quality.

The information we collect through compliance monitoring projects helps us to determine if there are problems with products on the market.

After we review compliance

When an inspector finds that a product or an activity doesn't meet legislative and regulatory requirements, we:

clarify what's necessary to achieve compliance
take action according to our compliance and enforcement policy, which can involve:
- requesting a voluntary stop of sale
- recalling a product
- suspending a company's site or establishment licence
- suspending a product's licence

It's then the regulated party's responsibility to take timely and appropriate action to comply with requirements.

We will inform you about any unsafe products by posting:

recall notices and public advisories

Once a project is completed, we make the results available to the public.

We use the results to:

ensure that people in Canada have access to health products that are safe, effective and meet quality standards
help us improve our regulatory oversight of health products
provide guidance to industry to help them meet their regulatory requirements

Completed compliance monitoring projects

Who is responsible for the safety of health products in Canada

The safety of heath products, including human drugs, NHPs and medical devices, is a shared responsibility between:

product licence holders
companies that manufacture, package, label or import health products
retailers
Health Canada

Product licence holders

Product licence holders are responsible for:

ensuring that they're complying with Canada's legislative and regulatory requirements
applying for and receiving a licence before selling a product in Canada
keeping their product licences up to date

Product licences include a:

drug identification number (DIN) for drugs
natural product number (NPN) or a homeopathic drug identification number (DIN-HM) for NHPs
medical device licence (Class II, III or IV) for medical devices

Companies

Companies that conduct activities related to health products such as manufacturing, packaging, labelling or importing are responsible for:

applying for, receiving and maintaining the appropriate establishment or site licence before they conduct their activities
follow the requirements for good manufacturing practices or ISO, which are described in the relevant regulations
ensure the products they handle follow all other requirements set out in the regulations, including those about product quality

Retailers

Retailers must verify whether they require an establishment or site licence if they conduct activities beyond selling health products (for example, importation). They are responsible for making sure that the health products they sell have a valid product licence.

Health Canada

We regulate the safety and quality of health products. We use several ways to confirm that health products are meeting regulatory requirements, such as:

responding to complaints
examining products at the border
testing products at our laboratories
monitoring international information
conducting compliance monitoring projects

We take action when a company or product isn't in compliance with the Food and Drugs Act or its regulations. Actions taken are based on the risk posed to the people of Canada.

We try to achieve compliance by working with the regulated party. But we will take the necessary actions to address non-compliance to reduce the risk to people in Canada if needed. Our main goal is to manage the risks to individuals by using the most appropriate level of intervention.

How to report a complaint

We want to hear from you if you have a complaint about a health product or a company that handles health products. Report it by using the health product complaint form.

You can report adverse reactions to health products to Canada Vigilance using the online reporting form.

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Date modified:: 2025-02-28

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