Post-Notice of Compliance (NOC) Changes: Safety and Efficacy 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. These new drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceutical and certain biotechnological products for veterinary use, including 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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