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 […]
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 […]
Completing the web-based natural health product licence application form can be a vexing experience for applicants in pursuit of a product license from Health Canada. Below we list some dos and don’ts to keep in mind when working with the application form. Dos Don’ts
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 […]
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 […]
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 […]
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 […]
The Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) was announced in Canada on November 27, 2020. This interim order (IO) introduces new measures to help prevent bulk importation programs, such as the one recently established by the U.S., from causing or worsening a drug shortage in Canada. Under the IO, certain drugs intended […]
Regulatory Compliance Just Got Easier
