Summary: Guidance Document- Post-Notice of Compliance (NOC) Changes: Safety and Efficacy

The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.

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Title (French)	Sommaire : Ligne directrice - Changements survenus après l'avis de conformité (AC) : Document sur l’innocuité et efficacité
Update Frequency	as_needed
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
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Open Canada Date Published	2021-05-26 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["document d'orientation", "sommaire", "modifications post-avis de conformité", "innocuité et efficacité", "cadre", "innocuité et efficacité", "sur la qualité", "aux nouveaux", "médicaments"], "en": ["summary guidance document", "post-notice of-compliance-changes", "safety-and-efficacy", "framework", "safety-and-efficacy", "quality guidance documents", "post-approval changes to-new-drugs"]}
Open Canada Collection	publication
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