Guidance Document: Notice of Compliance with Conditions (NOC/c)

Description

This guidance document combines and supercedes the policy and guidance documents for Notices of Compliance with Conditions (NOC/c) dated June 12, 2007. The revisions to this document incorporate the provision for the filing of Abbreviated New Drug Submissions (ANDSs) or Supplement to an Abbreviated New Drug Submissions (SANDSs) that reference a Canadian Reference Product (CRP) with NOC/c indications.

Resources

Name Format Description Link
Guidance Document: Notice of Compliance with Conditions (NOC/c) HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/notice-compliance-conditions.html
Guidance Document: Notice of Compliance with Conditions (NOC/c) HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/avis-conformite-conditions.html

Tags

Topics

Categories