Monitoring health products on the Canadian market

We monitor the compliance of health products on the market through proactive activities such as compliance monitoring projects. Learn more about these activities below.

How we monitor compliance

Health Canada is responsible for helping Canadians maintain and improve their health. Our compliance and enforcement activities help protect you against health and safety risks. We monitor the compliance of health products on the market in different ways. One way we do this is through proactive compliance monitoring projects (CMP).

Health products must meet legislative and regulatory requirements in order to be legally sold in Canada. 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 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)

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. Through these projects, we collect information that helps us to determine if there are additional problems with products on the market.

What we do as part of our monitoring

During compliance monitoring, 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 is conducted to complement our complaint-based verifications and routine inspection programs for health products. We use compliance monitoring to gather more information on specific issues or as opportunity for compliance promotion. Many regulated parties involved in our compliance monitoring projects use them as a chance to clarify the requirements in order to follow them better.

After we review compliance

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

clarify what's necessary to achieve compliance
take action according to our Compliance and Enforcement Policy (POL-0001) such as;
- requesting a voluntary stop of sale
- recalls
- suspensions of a company's site or establishment licence
- suspension of 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
reports outlining the findings from compliance monitoring projects

Completed reports on compliance monitoring

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

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 conduct activities such as 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 regulatory requirements
applying for and receiving a product licence before a product can be legally sold in Canada
keeping their product licences up to date

Product licences include a Drug Identification Number (DIN) for drugs, a Natural Product Number (NPN) or a homeopathic Drug Identification Number (DIN-HM) for NHPs or a 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 prior to conducting 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 license 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

It's our responsibility to regulate the safety and quality of health products. We use a number of ways to confirm that health products are meeting regulatory requirements, such as:

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

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

Usually, we achieve compliance through a cooperative approach with the regulated party, but if needed, we will take the necessary actions to address non-compliance to reduce the risk to Canadians. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians 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.

Adverse reactions to health products can be reported to Canada Vigilance using the online reporting form.

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