Regulatory AffairsNatural Health Products require a site license and a product license to be marketed in Canada. License applications are submitted for review through Health Canada’s Natural Health Product Directorate (NHPD). Once a product is found to be in compliance with the requirements of the Natural Health Product Regulations and is approved for safety and efficacy, its label will bear a natural product number (NPN) or a homeopathic identification number (DIN-HM).
Product LicenseWe assist clients in evaluating the efficacy, safety and quality information of their products with the goal of making them eligible for licensing. The first step in this process is a preliminary product review and recommendations. We identify critical gaps in the standards of evidence for the efficacy, safety and quality of the product within the framework of Canada’s Natural Health Product Regulations. We provide recommendations on how to proceed with the NHP license application process and whether changes must be carried out in order to make an appropriate health claim for the product.
We upload completed NHP Product License applications and supporting documentation to the E-Submission Builder software. Once in “hcs.” format, the application is submitted securely online to the NHPD via Canada Post ePoste.
Site LicenseWe facilitate the NHP site license application process by providing advice and support. A site license application will require six months of quality assurance records and details concerning a product’s manufacture, packaging, labelling and distribution. In order to be licensed, manufacturers, packagers, labellers and importers must show that they follow good manufacturing practices (GMPs).
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