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The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs (ie. changes to a drug that have received a NOC pursuant to section C.08.004 of the Food and Drug Regulations). This guidance document provides overarching authorities, a general description of the reporting categories and drug submission filing information.
The Framework, Safety and Efficacy and Quality guidance documents apply to sponsors intending to make post approval changes to new drugs.
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.
The purpose of this Notice of Amendment is to notify the addition of avilamycin to both the Human and Veterinary Prescription Drug List (PDL).
The purpose of this Notice of Amendment is to notify about the addition of casirivimab and imdevimab to the Prescription Drug List (PDL) for human and veterinary use.
The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for diclofenac on the Prescription Drug List (PDL). Only the Human part of the PDL was revised; the listing for Veterinary use will remain unchanged.
The purpose of this Notice of Amendment is to notify that Health Canada will switch certain uses of Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL). The Veterinary List will remain unchanged.