Verifying compliance of health products on the market: April 1, 2015 to March 31, 2016
In Canada, health products are regulated under the Food and Drugs Act and its Regulations. Read about how Health Canada protected the health and safety of Canadians by verifying the compliance of health products found on the Canadian market.
Note that the information below spans April 1, 2015 to March 31, 2016 and complements other information that the Department also publishes, such as pre-market reviews, facility inspections for Good Manufacturing Practices as well as monitoring of adverse events.
Health products include:
- Drug products such as over-the-counter drugs, prescription drugs and veterinary drugs.
- Natural health products such as vitamins, supplements, homeopathic medicines and traditional medicines.
- Medical devices such as bandages, toothbrushes, pacemakers, pregnancy kits and hospital beds.
Actively preventing unsafe health products from entering Canada
A large volume of health products come into Canada from other countries. These can include products purchased online by individuals or company supply chains that start outside of Canada. Not everything arriving at the border meets Canadian law.
Health Canada works with the Canada Border Services Agency (CBSA) to prevent unauthorized health products from entering Canada.
Health Canada participates in the annual Operation Pangea which is an international week of action coordinated by INTERPOL that combats the sale of illegal medicines online. The focus for 2015 was on unauthorized and unregulated internet sites that sell illegal drugs and medical devices. The products on these sites may be cheaper and easily purchased but riskier because they may be counterfeit (i.e. "fake"), contain the wrong level of an active ingredient, or contain toxic substances. During the week, the CBSA referred suspected non-compliant shipments of drugs and medical devices to Health Canada for inspection. Where warranted, Health Canada referred shipments to the Royal Canadian Mounted Police for investigation of intellectual property right infringements.
Following up on complaints
Health Canada hears from consumers when they have a complaint about a health product that they use.
Companies are also required to report any recalls of health products to Health Canada which they undertake. Health Canada monitors the effectiveness of a company's recall and any necessary steps they take to correct the issue and prevent it from happening again.
The Food and Drugs Act contains a provision on recalls.
For drugs, a recall is any action taken by a company to remove product from further sale or use, or correction of a product.
Under the Medical Devices Regulations, the definition is broader and includes notifying users of a defective or potentially defective device.
Finding problems early
Health Canada is also interested in identifying problems before it hears about them from another source. Health Canada carries out proactive surveys (planned reviews) of health products on the market as a way to verify that industry and health products are following Canadian laws. Starting in 2016, Canadians are able to read about these planned reviews for the first time.
Health Canada laboratories proactively review the quality of authorized human drugs through its Drug Quality Surveillance Program. They also test health products that inspectors identify through their daily work.
When Health Canada finds a product that does not meet the Food and Drugs Act, the department takes appropriate action to minimize the risk to Canadians and to correct non-compliance by industry. Consumers, patients and industry can learn more about unsafe products through our recall notices and public advisories.
Unauthorized health products are risky
Every year, we come across many unauthorized health products at the Canadian border and in the marketplace. Unauthorized products have not been reviewed for safety, quality or efficacy by Health Canada and can include counterfeit products. These can be dangerous to your health because they may contain hidden ingredients not listed on the label, dangerous additives or contaminated ingredients.
Examples of more common counterfeit or adulterated products that we saw include sexual enhancement products and weight management products (including workout supplements and fat burning pills).
Play an active role in staying safe
Everyone plays a part in the safety of health products.
Be informed and careful about where your health products come from.
Check that health products you use are authorized in Canada:
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