NNHPD NPN

Canada regulates supplements as Natural Health Products under the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD) within Health Canada — distinct from US DSHEA, EU food supplements and Australia therapeutic goods frameworks. Every NHP sold or imported into Canada requires a Natural Product Number (NPN, 8 digits) or DIN-HM (Drug Identification Number-Homeopathic Medicine) issued by NNHPD through Product Licence Application review. The NNHPD Compendium of Monographs (~1,000 monographs spanning single ingredients, multi-ingredient products and traditional system products) drives PLA evidence class: Class I (60-day review target) for fully monograph-compliant products, Class II (90 days) for monograph deviations, Class III (210 days) for products without monograph requiring full custom evidence dossier. Manufacturing, packaging, labelling, importation and wholesale sites require Site Licence under Canadian GMP for NHPs (Part 3 of the Regulations) — foreign manufacturers do not hold direct Canadian Site Licences; the Canadian importer holds Site Licence with import scope and assumes GMP equivalence verification responsibility for foreign manufacturers (FDA, TGA, NSF, USP or equivalent evidence). Bilingual English and French label content is mandatory for every mandatory element — sloppy French translation is a frequent compliance finding; Quebec Charter of the French Language may require French-primary labelling for Quebec-distributed SKUs. Lifecycle obligations include 15-day serious adverse reaction reporting to Canada Vigilance, annual adverse reaction summary, Health Canada Recall and Safety Alerts compliance, post-market compliance review, and Product Licence Amendment for any change to licensed product (formula, claim, dose, target population, manufacturer) before implementation. US DSHEA compliance does not substitute for NPN — selling unlicensed NHP triggers Health Canada Stop Sale, CBSA import refusal and potential prosecution.