Reporting complaints about health products
Health Canada encourages individuals to send in their complaints about health products to the Regulatory Operations and Enforcement Branch (ROEB). ROEB manages health product complaints on a priority basis according to the risk to people's health and safety, with those considered high-risk receiving first priority.
On this page
- Health products
- Examples of health product complaints
- How to report a health product complaint
- What happens after you submit a health product complaint
- Examples of other types of complaints and where to report
Health products are regulated under the Food and Drugs Act and its Regulations. Health products include the following:
Medical devices are health or medical instruments used to treat, mitigate, diagnose or prevent a disease or abnormal physical condition. Devices range from adhesive bandages, toothbrushes and contact lenses to complex devices, such as x-ray units, insulin pumps and pacemakers. They also include in vitro diagnostic devices, such as cancer screening tests, blood glucose monitors and pregnancy test kits.
pharmaceutical drugs (human and animal)
Pharmaceutical drugs include prescription drugs (require a medical prescription to be dispensed) and non-prescription drugs (obtained without a prescription).
human biological products
cells, tissues and organs for transplantation
Cells are the basic building blocks of all humans. Cells used for transplantation include stem cells.
Tissues are a group of cells that have similar structure and that function together as a unit. Tissues used in transplantation include:
- cardiovascular tissues (for example, veins)
- connective tissue (for example, fascia, which support structures in the body)
- musculoskeletal tissues (for example, bone, cartilage, tendon, ligaments)
- ocular tissues (for example, cornea, sclera, whole globe)
Organs are a group of tissues that have been adapted to perform a specific function. An organ (for example, kidneys, liver, heart, lungs, pancreas) is transplanted to someone whose organ has failed and is no longer functioning as required.
blood for transfusion or plasma for use in the manufacture of a drug for human use
Blood includes whole blood that is donated and then separated into blood components (for example, red blood cells, plasma, platelets).
biotechnology products and blood products
Biotechnology and blood products refer to drugs that come from living organisms or from their cells. They are used to treat medical conditions such as diabetes and some forms of cancer.
Vaccines are products that produce immunity to a specific disease. Most vaccines are given by injection (needle) but some are given orally (by mouth) or nasally (sprayed into the nose). They protect people against serious and potentially deadly diseases, such as diphtheria, measles, polio and tetanus.
natural health products (including homeopathic medicines)
Natural health products are naturally occurring substances. They are often made from plants, but can also be made from animals, micro-organisms and marine sources. They are used to prevent or treat an illness or condition, reduce a health risk or maintain good health. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.
veterinary health products
Veterinary health products (such as vitamins and minerals) are used to maintain or promote the health and welfare of pets and food-producing animals. They are not used to diagnose, treat or prevent diseases.
Radiopharmaceuticals are pharmaceutical drugs that have been made radioactive for the purpose of diagnosing illness.
Examples of health product complaints
The following are examples of typical health product complaints:
- counterfeit products
- unauthorized sale of health products
- product mix-ups and incorrect components
- particulate matter, foreign materials and contamination
- labelling errors
- concerns about the safety of a medical device or its ability to perform as claimed
- concerns with the conduct of a clinical trial or the health product of a clinical trial
- violations of the Food and Drugs Act and associated Regulations related to health products
How to report a health product complaint
To report a health product complaint, fill out the appropriate form from the following list:
- medical devices
- pharmaceutical drugs (human and animal)
- human biological products (human blood, cells, tissues, organs)
- biological drugs (such as vaccines)
- natural health products (including homeopathic medicines)
- veterinary health products
- clinical trial health products
Need help to complete or submit your health product complaint? Please contact ROEB at 1-800-267-9675.
When reporting a complaint, you should provide certain information to help ROEB assess what priority to assign your complaint. This will also help reduce delays in taking the necessary compliance action(s).
Please provide the following information:
- your contact information
- response to the privacy notice questions in the complaint form
- a description of the issue
- the product's name
- where the health product was advertised, purchased, obtained, used or seen available for sale
- the product licence number, catalogue or model number, lot number, expiry date (if available)
Also provide the following items:
- photos of the product showing labels
- invoices, sales receipts
- website links
- brochure, advertising materials
- any additional information you wish to include (such as correspondence with the manufacturer or retailer)
Your personal information is protected under the Privacy Act. It's only shared if you have given your consent in the form, unless the disclosure is required or otherwise authorized by law.
What happens after you submit a health product complaint
ROEB verifies complaints from consumers and industry about the quality and safety of health products in Canada. ROEB deals with complaints on a priority basis according to the level of risk to people's health and safety. High-risk complaints receive first priority. Please note that not all complaints will lead to further action from ROEB.
ROEB does not provide ongoing feedback on the status and outcome of compliance actions taken. However, we do post health and safety information on our website. This includes recalls and safety alerts about health products that may have occurred because of a complaint. This is the best mechanism for the public to stay informed of health and safety information from Health Canada.
The compliance and enforcement actions taken by ROEB are consistent with our compliance and enforcement policies for health products (POL-0001). Our goal is to achieve compliance using the most appropriate level of intervention.
Examples of other types of complaints and where to report
To submit a complaint about other issues, please use the following links:
- side effects (adverse events) in humans or animals for prescription and non-prescription medicines
- side effects (adverse events) in humans for clinical trials
- consumer products
- tobacco and vaping products
- drug or device marketing (advertising) complaints
- special access program for drugs and health products
- controlled drugs and substances
- human reproductive materials (for example, donor sperm and ova) or activities related to assisted human reproduction in Canada (for example, reimbursement of surrogate mothers)
- cannabis and medical marijuana (including side effects)
- importation of human pathogens
To submit a complaint about a health care professional, please use the following links:
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