Post-Notice of Compliance (NOC) Changes – Quality Guidance (English, HTML)

Post-Notice of Compliance (NOC) Changes – Quality Guidance: English HTML file. From Health Canada, updated Jul 2021. View metadata, licence and the direct download on CanQuery.

Format

HTML

Access

Original download only

Publisher-reported update

2021-07-07

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. This may include pharmaceuticals, biologics and radiopharmaceuticals for human use and pharmaceutical, radiopharmaceutical and certain biotechnological products for veterinary use.

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