Adverse Reaction Reporting Information
Who Can Report an Adverse Reaction?
Anyone -- including consumers, patients, caregivers, physicians, pharmacists, nurses, and dentists can report an adverse reaction to drugs or health products on the Canadian market.
Reporting is voluntary for the general population, but is mandatory for Market Authorization Holders (MAH) as required by Canada's Food and Drugs Act.
What to Report?
You do not have to be certain that a health product caused the reaction in order to report it. Adverse reaction reports are, for the most part, only suspected associations. Health Canada wants to know about all suspected adverse reactions, but especially if they are:
- unexpected (not consistent with product information or labelling), regardless of their severity;
- serious, whether expected or not; or
- related to a health product that has been on the market less than 5 years.
When to Report an Adverse Reaction?
You should report an adverse reaction soon after the reaction occurred, even if you are not certain that a particular health product was the cause.
Why Report an Adverse Reaction?
All marketed drugs and health products have benefits and risks. Although health products are carefully tested before they are licensed in Canada, some adverse reactions may become evident only after a product is in use by the general population.
When you submit a suspected adverse reaction report, you contribute to the ongoing collection of information that occurs once health products are on the market.
Your report may contribute to:
- the identification of previously unrecognized rare, or serious adverse reactions;
- changes in product safety information, or other regulatory actions such as the withdrawal of a product from the Canadian market;
- international data regarding benefits, risks or effectiveness of drugs and health products; and,
- health product safety that benefits all Canadians.
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