Drug Identification Numbers (DIN) are issued to prescription and non-prescription pharmaceuticals, disinfectants (e.g., contact lens disinfectants) and sanitizers with disinfectant claims (e.g., hand rubs), and pre-marketing approval of pharmaceutical products is required. A DIN uniquely identifies the manufacturer, brand name, active ingredients (identity and strength), dosage form, and route of administration of a drug product. In order to qualify as a non-prescription (OTC) drug, a product must be free from all substances identified on Health Canada’s Prescription Drug List.
DIN applications are evaluated by Health Canada’s Therapeutic Products Directorate (TPD) for safety, efficacy, and quality, and the TPD’s requirements for a DIN application depend on the type of product being made available for sale. Products that comply with a labelling standard or category IV monograph published by Health Canada are eligible for a simplified application process, expedited review, and reduced assessment fees. Products that do not conform to a labelling standard or category IV monograph require more extensive review with Health Canada, including the submission of independent clinical trials and/or comparative pharmacological investigations of the drug in question.
NHP Consulting can advise on the application requirements for your specific product and prepare DIN applications to the TPD, including the assembly of evidence packages for health claim substantiation, safety, and efficacy.