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