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

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.

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Additional Info

Field	Value
Last Updated	April 17, 2026, 21:49 (UTC)
Created	April 17, 2026, 21:49 (UTC)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2013-04-10 00:00:00
open_canada_keywords	{"fr": ["Avis", "adoption de l'International Conference on Harmonisation", "ICH", "guidance on Periodic Benefit Risk Evaluation Report", "ICH Topic E2C(R2)", "titulaire de l'autorisation de mise sur le marché", "données sur les effets indésirables des médicaments", "rapport de synthèse annuel sur les effets indésirables des médicaments"], "en": ["Notice", "adoption of the International Conference on Harmonisation", "ICH", "guidance on Periodic Benefit Risk Evaluation Report", "ICH Topic E2C(R2)", "market authorization holder", "adverse drug reaction data", "adverse drug reaction annual summary report"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Avis - L'adoption de la directive de l'International Conference on Harmonisation (ICH) intitulée: rapport périodique d'évaluation des avantages et des risques - ICH EC2 (R2), à partir du 1er mars 2013
update_frequency	as_needed