Description

Section C.01.018 of Division 1 of the Food and Drug Regulations requires the Market Authorization Holder (MAH) to analyze adverse drug reaction data and prepare an annual summary report. Annual summary reports are to be submitted when requested by Health Canada. In addition, Section C.01.018(4) requires that the MAH notify Health Canada without delay if there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report.

Resources

Name	Format	Description	Link
Notice - Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report - ICH Topic E2C(R2), as of March 1, 2013	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/notice-adoption-international-conference-harmonisation-guidance-periodic-benefit-risk-evaluation-report-topic-march-1-2013.html
Notice - Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report - ICH Topic E2C(R2), as of March 1, 2013	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/avis-adoption-directive-international-conference-harmonisation-intitulee-rapport-periodique-evaluation-avantages-risques-partir-1er-mars-2013.html

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