Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update

Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing. 2024-04-04 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNotice of clarificationdrug manufacturerssponsorsRisk Management Planscontrolled distribution programsCanadian Reference Productsgeneric drugconducting comparative testing Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - UpdateHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/notice-clarification-drug-manufacturers-sponsors-risk-management-plans.html Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - UpdateHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/avis-clarification-fabricants-promoteurs-medicaments-plans-gestion-risques.html

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing.

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