Side Effect Reporting Form

Protected when completed - B^{Footnote 1}

Instructions to Complete the Side Effect Reporting Form

How do I complete the Side Effect Reporting Form?

• All sections of the form should be filled in as completely as possible. Use a separate form for each patient. Attach an additional form if there is more than one suspected health product. Additional pages may be attached if more space is required. Please provide the product label where possible.
• Follow-up information for a side effect that has already been reported can be submitted using a new form, indicating that it consists of follow-up information, including, if known, the date of the original report and the report number provided in the acknowledgement.

What is a side effect?

A side effect (also known as adverse reaction) is a harmful and unintended response to a health product. Health products include prescription and non-prescription medications; natural health products; biologics (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs) radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims. This includes any undesirable patient effect suspected to be associated with health product use. An unintended effect, health product abuse, overdose, interaction (including drug-drug and drug-food interactions) and unusual lack of therapeutic efficacy are all considered to be reportable side effects.

What is considered a serious side effect?

A serious side effect is one that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Side effects that result in significant medical intervention to prevent one of these listed outcomes are also considered to be serious.

What types of side effects should be reported?

All suspected side effects should be reported, especially those that are:

• unexpected, regardless of their severity (i.e. not consistent with product information or labelling);
• serious, whether expected or not;
• reactions to I health products (on the market less than five years), regardless of their nature or severity.

How to submit your completed form

• Fax: 1-866-678-6789
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Health Canada
  Address locator 1908C
  Ottawa ON K1A 0K9

Other ways to report a side effect

• Online: canada.ca/medeffect
• Telephone: 1-866-234-2345

Do not send reports by e-mail. Health Canada is not able to ensure secure transfer of information by e-mail.

Other information

• Reporting a side effect does not constitute an admission that medical personnel or the product caused or contributed to it.
• Side effect reports are, for the most part, only suspected associations. A temporal or possible association is sufficient for a report to be made. Reporting of a side effect does not imply a definitive causal link.
• Health professionals and consumers may also report side effects to the market authorization holder. Indicate on your form sent to Health Canada if a case was also reported to the product's market authorization holder.

For more information about side effect reporting, call Health Canada at 1-866-234-2345 or contact a regional office directly:

• British Columbia
  CanadaVigilance_BC@hc-sc.gc.ca
• Alberta, Northwest Territories and Yukon
  CanadaVigilance_AB@hc-sc.gc.ca
• Saskatchewan and Nunavut
  CanadaVigilance_SK@hc-sc.gc.ca
• Manitoba
  CanadaVigilance_MB@hc-sc.gc.ca
• Ontario
  CanadaVigilance_ON@hc-sc.gc.ca
• Québec
  CanadaVigilance_QC@hc-sc.gc.ca
• New Brunswick, Nova Scotia, Prince Edward Island, and Newfoundland and Labrador
  CanadaVigilance_ATL@hc-sc.gc.ca