Submitting risk management plans draft guidance document: RMP summary template

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The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.

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Submitting risk management plans draft guidance document: RMP summary template HTML https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans/summary-template.html
Submitting risk management plans draft guidance document: RMP summary template HTML https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/presentation-plans-gestion-risques/modele-sommaire.html

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