Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only)
Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) is an open dataset from Health Canada with 2 files (HTML); catalogue record updated 2021-07-07. On CanQuery you can follow the original downloads. Files are available in English and French.
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, including those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.
- Publisher
- Health Canada
- Resources
- 2
- Catalogue metadata updated
- 2021-07-07
Data overview
- Formats
- HTML
- File languages
- English, French
Official sources and licences
Resources
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) (English, HTML) HTML · Download HTML
- Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (for pharmaceutical, biologic and radiopharmaceutical drugs for human use only) (French, HTML) HTML · Download HTML