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.

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Title (French) Avis de clarification aux fabricants et promoteurs de médicaments - Plans de gestion des risques - Mise à jour
Update Frequency as_needed
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Sensitivity Level unrestricted
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Open Canada Date Published 2020-08-13 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["Avis de clarification", "fabricants de médicaments", "promoteurs", "plans de gestion des risques", "programmes de distribution contrôlée", "produits de référence canadiens", "médicament générique", "réalisation d'essais comparatifs"], "en": ["Notice of clarification", "drug manufacturers", "sponsors", "Risk Management Plans", "controlled distribution programs", "Canadian Reference Products", "generic drug", "conducting comparative testing"]}
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