PV Bulletin

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Country Guides

Country pharmacovigilance requirements, QPPV obligations, EU QPPV, reporting timelines, and local affiliate compliance guides.

publicHealth Canada · Canada · Updated May 23, 2026

Health Canada updates RMP submission guidance effective 1 July 2025

Urgency: High

1) Retrieve and review the updated “Submitting risk management plans guidance document” (PDF) and linked templates referenced from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a summary in English and French and use of the RMP summary attestation/acknowledgment form. 3) Ask Regulatory Intelligence/RA to brief PV leadership on the Agile Licensing notice timeline (RMP provisions in force 1 April 2027) and confirm how transitional provisions will be operationalized for existing RMPs submitted prior to that date.

Label GovernanceRisk ManagementLocal Safety Officer
SOP Impact5 SOPs
ConfidenceHigh
Relevant for: Local Safety Officer, Signal Management Lead, Labeling Lead
verifiedRegulatory action: Country Guides
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