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Pharmacovigilance Requirements in Canada





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Patient Identifier - Four Minimum Criteria - Canada

One or more of the following should automatically qualify a patient as identifiable: age or age category (e.g., adolescent, adult, elderly), gender, patient identification number, or reference to "a patient".

PSUR or Aggregate Reports in Canada

The manufacturer shall prepare an annual summary report of all information relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months. These are also known as CAR or Canadian Annual Reports.

NOT routinely required to be submitted to Health Canada. However, while preparing the annual summary report, the manufacturer concludes that there has been a significant change, it shall notify the Minister (Health Canada) without delay, in writing, unless this has already been done.

Discontinued Products in Canada - Reporting Requirements

In accordance with the Regulations, the MAH must report any AR information received prior to the discontinuation of the sale in Canada. Although the MAH is not obliged to report any new cases of adverse reactions received following the product's discontinuation, Health Canada strongly encourages the reporting of all serious adverse reactions and may request the provision of this information. If a serious AR was known to the MAH before the discontinuation of sale, they must still report as per the expedited reporting requirements even if the end of the 15-day reporting timeframe as required by the Regulations is after the date on which sales were discontinued. Follow-up information for cases known to the MAH prior to the discontinuation of sale should be reported to MHPD in accordance with the Regulations and should be sought as part of the follow-up practices described under Section 3.4.

When expired and unexpired lots of a discontinued product continue to be available in pharmacies, the MAH is still under obligation to report ARs to MHPD if this information was received by the MAH prior to the discontinuance. As mentioned above, Health Canada may still request the MAH to provide information that it receives following the discontinuation of sales.

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