Summary: Guidance Document - Post-Notice of Compliance (NOC) Changes: Framework Document (Pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
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| Title (French) | Sommaire : Ligne directrice - Changements survenus après l'avis de conformité (AC) : Document cadre (Médicaments pharmaceutiques, biologiques et radiopharmaceutiques à usage humain seulement) |
| Update Frequency | as_needed |
| Geographic Scope | [] |
| Criticality Level | [] |
| Sensitivity Level | unrestricted |
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| Open Canada Date Published | 2020-11-19 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", "AC", "document-cadre", "produits pharmaceutiques", "biologiques", "radiopharmaceutiques", "médicaments à usage", "humain uniquement", "cadre", "documents", "d'orientation", "sur l'innocuité", "efficacité", "qualité s'appliquent", "promoteurs", "qui ont l'intention", "de faire", "une approbation", "postérieure", "changements apportés", "aux nouveaux médicaments"], "en": ["summary guidance document", "post-notice-of-compliance-changes", "NOC", "framework document", "Pharmaceutical", "biologic", "radiopharmaceutical", "drugs for human-use-only", "framework", "Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs"]} |
| Open Canada Collection | publication |
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