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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. In the absence of a guidance specific to Quality changes to drugs which were approved through a Drug Identification Application - Biologics (DIN-B drugs), this guidance document applies to those products. This guidance also applies to those submissions for which a NOC has been recommended but issuance of the NOC has been placed on hold.

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.

The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were introduced originally by Industry Canada under the Patent Act. The PM(NOC) Regulations intersect with drug approval under the Food and Drugs Act and Division 8 of the Food and Drug Regulations.

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice

Notice of Compliance with Conditions - Qualifying Notice.

Notice of Compliance with Conditions - Qualifying Notice