Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality Document (French, HTML)

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HTML

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Publisher-reported update

2023-09-29

This guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. In the absence of a guidance specific to Quality changes to drugs which were approved through a Drug Identification Application - Biologics (DIN-B drugs), this guidance document applies to those products. This guidance also applies to those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

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