Entries by admin

Finished Product Specifications and NHP Product Licenses

The Natural and Non-prescription Health Products Directorate has made a significant update to requirements for natural health product license applications. The June 15, 2026, Natural Health Product Licensing Bulletin has confirmed thatfinished product specifications (FPS) are no longer required for Class II and Class III product license applications and amendments. This change, effective June 25, […]

Foreign Site Reference Numbers

Foreign manufacturers planning to export natural health products to Canada face a challenging and somewhat complex procedure based on the requirements of the Natural Health Product Regulations. Foreign sites must be deemed compliant with Health Canada’s Good Manufacturing Practices (GMP) in addition to being listed on an importers site license, all before selling products to […]

Product License Amendments – Natural Health Products

In order to sell natural health products in Canada, a product license with an associated Natural Product Number (“NPN”) is required from Health Canada’s Natural and Non-prescription Health Products Directorate. An NPN is specific to a product’s brand name, ingredients, and recommended conditions of use. These elements may undergo changes during the time a natural […]

Natural Health Product Licensing – Application Tips

The Natural and Non-Prescription Health Products Directorate (NNHPD) provided valuable application tips at the recent Stakeholder Meeting of October 28, 2021. Applicants that follow these suggestions will have a better chance of receiving licenses without having to resubmit or face delays in processing. Site licence applications should be submitted using the most recent Web based […]

COVID-19 Interim Site License Transition

In March 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) introduced interim measures to enable expedited site licensing for alcohol-based hand sanitizers. As of August 2020 the NNHPD stopped accepting new site license applications under the expedited regulatory pathway. NNHPD also indicated that moving forward, any site licenses issued under the interim measures would […]

Inspector Roles Under the Food & Drugs Act

Whether you are importing health products into Canada or preparing to import, the latest policies on Health Canada inspectors and their rights offer valuable insight into compliance and enforcement programs under the Food & Drugs Act. The inspection provisions in the Act are designed to protect consumers who are vulnerable to risks posed by unauthorized […]

 Natural Health Product GMP Inspection Pilot

The Natural and Non-Prescription Health Products Directorate of Health Canada has announced the introduction of a GMP Inspection pilot program for natural health product facilities. The program is anticipated to begin in February/March of 2021.  Site inspections are planned to complement the current paper-based process for site licensing (GMP). Goals of the pilot inspection program […]