Natural Health Products Licensing

Natural health products licensing holds no secrets to the dicentra team, since the inception of the Natural health products Regulations in Canada in 2004, we have successfully acted on behalf of hundreds of clients world-wide and filed thousands of NHP product license applications (PLAs) to the Natural Health Products Directorate (NHPD) of Health Canada. Consistently achieving a natural health product licensing success rate that is well above the industry average, we have become recognized as the leading natural health products consultant.

Our services in Natural Health Products Licensing include:

• Initial Product Classification (to verify product qualifies as an NHP)
• Preparation of Ingredient Issue Forms
• Preparation of Safety & Efficacy Summary Reports
• Preparation of Finished Product Specifications & Quality Summary Reports
• Preparation of compliant draft labels
• Preparation of submissions in ePLA format
• Filing Notifications and Amendments
• Responding to government Clarification Requests (CRs)
• Responding to government Information Request Notices (IRNs)
• Health Claim Substantiation Assessment and Product Development (See also Health Claim Substantiation Assessment page)
• Preparing Master File Applications
• Arranging pre-submission meetings with the NHPD

Our highly qualified team is experienced in the preparation of all submission types, including traditional, non-traditional, homeopathic, combination, and compendial, and in all submission categories, including plant or animal materials, extracts, isolates, synthetics, probiotics, and enzymes.