Enhanced Pre-Licensing Review for Certain Non-Prescription Drug Products

Overview

Food and Drug Law
Food and Drug Regulatory LawHealth Canada is revising its process for approving non-prescription drug products supported entirely by one of the following eight established product monographs: Sunscreen Monograph; Acne Therapy; Anti-Dandruff Products; Antiseptic Skin Cleansers; Athletes Foot Treatments; Medicated Skin Care Products; Diaper Rash Products; or Throat Lozenges (known as Category IV DIN (DINF) submissions). 

Specifically, drug identification numbers (DINs) for these products will no longer be issued immediately following an attestation by the manufacturer that the products comply with the applicable drug monograph. Rather, in addition to the attestation, Health Canada will be validating all of the drug product applications prior to DIN issuance to ensure key elements (such as unacceptable medicinal or non-medicinal ingredient, unacceptable brandname, missing warning statements, etc.) are addressed prior to approval.

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