Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans

Description

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for certain drug products. This notice describes what is required for certain drug products.

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Name Format Description Link
Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/profile-guidance-document-submission-risk-management-plans-follow-commitments/notice-clarification-drug-manufacturers-sponsors.html
Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/profil-ligne-directrice-presentation-plans-gestion-risques-engagements-matiere-suivi/avis-clarification-fabricants-promoteurs-medicaments.html

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