In Canada, nicotine pouches containing 4 mg nicotine or less per dosage unit are considered Nicotine Replacement Therapy (NRT) Natural Health Products (NHPs); pre-market authorization from Health Canada is required for legal sale. Product quality, safety and efficacy must be demonstrated to Health Canada via a class III product licence application (PLA). Product safety and efficacy must either be supported by a long-term cessation study or Bioequivalence (BE) to a Reference Product (a licensed NHP supported by a long-term cessation study). Health Canada has also recently implemented NRT-specific restrictions on product flavor, labelling, and marketing. Chemular and Gowling teams have combined their know-how on multiple applications, leveraging on Chemular’s product development and testing knowledge plus Gowling’s scientific, legal and regulatory expertise. This poster presents an optimized pathway to ensure a time-efficient development and tests strategy in line with Health Canada requirements and review approach.
October 21, 2026
