What Canada Natural Health Products Regulations 2003 - NPN Product Licence, GMP Site Licence and Health Canada Compliance requires
Canada's Natural Health Products Regulations SOR/2003-196 (NHPR, in force January 1, 2004, under the Food and Drugs Act R.S.C. 1985 c. F-27) created a comprehensive licensing regime for natural health products (NHPs) including vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and amino acids; every NHP sold in Canada must hold a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) granted by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD); market authorisation requires safety and efficacy evidence from pharmacopoeias, traditional use data, or clinical studies; manufacturers, packagers, labellers, and importers must hold a Site Licence (SL) and comply with GMP standards in Schedule 2 of the NHPR; adverse reaction reports must be filed with Health Canada within 15 days (serious unexpected) and 30 days (serious expected); label must bear NPN number, recommended use, recommended dose, risk information, storage conditions, and lot number; Health Canada may issue compliance orders, seize products, and require recalls for non-compliance; 2023 amendments under Bill S-5 (Strengthening Environmental Protection for a Healthier Canada Act) introduced new NHP oversight provisions.
Pillar: Pharmaceuticals & Life Sciences · Authority: Natural and Non-prescription Health Products Directorate (NNHPD), Health Canada; Government of Canada · Version: 1.0.0 · Last updated:
Primary source: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html
SHA-256 integrity: 1e94919889c670050d264578a035ff68e297f02d25c2f2310ce35dd02cdb9854
Primary Citations — 6 traced to source
- Part 2 (product licence - NPN application, evidence requirements, 60/180-day review timelines); Part 3 (site licence - GMP requirements, importation); Part 4 (adverse reaction reporting - 15-day serious unexpected; 30-day serious expected); Part 5 (labelling - mandatory elements including NPN, bilingual, lot number, expiry, risk information); Part 8 (compliance and enforcement - compliance orders, recall) — Natural Health Products Regulations SOR/2003-196 - Justice Laws Canada
- NPN online application portal; Health Canada NHP Monographs database; Licensed Natural Health Products Database (NPN verification); GMP site licence application process; adverse reaction reporting (MedEffect Canada); post-market review programme — Health Canada - Natural and Non-prescription Health Products Directorate (NNHPD)
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