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An NHP Master File (NHP-MF) is a valuable regulatory option for suppliers wishing to keep novel and proprietary manufacturing/processing information about their product or ingredient confidential. NHP Master Files allow your customers to cross-reference your file for their own Product Licence Application (PLA) submissions without having to disclose proprietary information to them.
NHP Master Files are held in strict confidence by Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD), allowing information to remain confidential. Our regulatory affairs team will review all quality, manufacturing, generic, and product-specific data for applicability, and then compile a Master File that substantiates safety, efficacy, and quality. Explore our additional services for NHPs.
Learn how we can help you secure a Master File for your NHP in Canada.
