Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality Document
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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
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Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality DocumentHTMLEnglish publication HTML
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Guidance Document : Post-Notice of Compliance (NOC) Changes: Quality DocumentHTMLFrench publication HTML
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