Regulatory Overview: Non-prescription drugs in Canada: Post-market activities
On this page
- Post-market activities
- Complaints, recalls, and safety alerts
- Adverse reaction reporting
- Compliance and enforcement
Post-market activities
For a Drug Establishment Licence (DEL) holder conducting activities in respect of a drug under the Food and Drug Regulations, there are specific record-keeping and retention obligations that apply beyond pre-market submission or clinical trial record requirements. For example, finished product and drug production (quality) records must be kept for at least 1 year after the expiration date of the drug lot/batch. Records of sale and distribution must also be kept for at least 1 year after drug expiration date. These obligations help ensure product quality, traceability, and the ability to respond to compliance, safety or recall issues. The Regulatory Operations and Enforcement Branch of Health Canada is responsible for conducting compliance and enforcement activities.
If manufacturers identify any quality issues, they are required to notify Health Canada and take appropriate action, such as initiating a recall. The Marketed Health Products Directorate of Health Canada is responsible for monitoring the safety and effectiveness of authorized health products in Canada.
Complaints, recalls, and safety alerts
Health Canada issues safety alerts to inform Canadians about potential risks linked to health products, such as contamination or unexpected side effects. Complaints about a health product (e.g., labelling error, product quality concern) can be shared with Health Canada by submitting a Health product complaint form. Complaints are managed on a priority basis according to the risk to people's health and safety, with those considered high-risk receiving first priority.
Safety alerts are posted in the Recalls and Safety Alerts Database, where they can be quickly accessed alongside information on other health products. Recalls are public information and recall information can be found on Health Canada's Recalls and safety alerts page.
Industry is required to report drug recalls they initiate. For information on how to initiate a drug recall, visit Health Canada's Drug, natural health products and biocides recall guide. By providing timely updates, Health Canada helps Canadians make informed choices and protect their health.
Adverse reaction reporting
Adverse reactions are harmful and unintended responses to a drug product. Anyone who witnesses or experiences an adverse reaction can report it. However, market authorization holders and hospitals are required to report serious adverse reactions known to them to the Canada Vigilance Program of Health Canada.
For more information on adverse reaction reporting:
- Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals
- Reporting adverse reactions to marketed health products - Guidance document for industry - Canada.ca
- Preparing and submitting summary reports for marketed drugs and natural health products – Guidance for industry
Compliance and enforcement
Compliance and enforcement activities are a key element of safeguarding the drugs and health products to which Canadians have access. As part of its regulatory responsibilities, Health Canada is responsible for compliance monitoring and enforcement activities related to health products in order to verify that regulatory requirements are being applied appropriately.
For information on compliance and enforcement: