Canada’s approach to onsite inspections during COVID-19: Notice

From: Health Canada
Date published: 2021-04-07

Health Canada regulates health products, such as drugs and medical devices. We also regulate consumer and commercial products and substances, such as cosmetics, pesticides, tobacco, cannabis and controlled substances. As part of our regulatory activities, we conduct inspections to mitigate risks and protect the health and safety of Canadians. Learn more about what Health Canada does as a regulator.

During the COVID-19 pandemic, we continue to take a risk-based approach to inspections.

Onsite work remains a key tool in helping us fulfill our mandate to deliver essential inspection activities. Health Canada uses remote or virtual tools to complement onsite inspection activities. We're using these tools, where appropriate and without compromising the ability to verify and assess compliance, for all of the products and substances that we regulate.

When onsite activities are conducted, Health Canada is implementing appropriate COVID-19 mitigation measures in adherence with public health guidance. Along with COVID-19 screening self-assessments, such measures include:

• practising social distancing
• practising good respiratory etiquette and hand hygiene
• equipping inspectors with sanitation supplies, non-medical masks and other required PPE
• making adjustments for additional provincial, territorial, local and community specific public health guidance, where applicable

Health Canada inspectors are governed by applicable acts and regulations and follow procedures referenced in A Guide to Health Canada Inspections. As such, inspectors continue to have the power to enter any place or premises at any reasonable time where:

• a regulated activity is being conducted or
• a regulated product, article, device or thing, or relevant document is located

Anyone at the place of the inspection is legally required to give the inspector all reasonable assistance.

To stay safe and help limit the spread of COVID-19, Health Canada expects that public health guidance and mitigation measures will be followed while the inspector is onsite. Consideration for the health and safety of inspectors and regulated parties is a joint responsibility. Where it isn't possible to reduce the risks of COVID-19, we may explore other options.

Health Canada will continue to monitor developments regarding COVID-19 and adjust plans for onsite delivery, as needed.

Related links

• A guide to Health Canada inspections
• What Health Canada does as a regulator
• What's new: Compliance and enforcement
• Compliance and enforcement: Drug and health products
• Health Canada's regulatory response to COVID-19: Access to health products
• Policy on accessing the premises of a regulated party remotely to verify compliance