Description

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.

Resources

Name	Format	Description	Link
Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update	HTML		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 - Update	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/avis-clarification-fabricants-promoteurs-medicaments-plans-gestion-risques.html

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