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 SLA form to support the application. NNHPD no longer accepts PDF versions of the application form and using the PDF forms may result in a refusal of the application.
As per Health Canada’s Site License Guidance Document each site in the site license application must be supported by evidence of Good Manufacturing Practices (GMP). As a result of these requirements, there could be a high number of files submitted with a site license application. Appropriate submission document identification and structure can help avoid delays in processing of site license applications. File names should be no longer than 15 characters.
Site license renewals are required on a yearly basis after licensing and involve the submission of GMP evidence to demonstrate ongoing GMP compliance. Renewals should be submitted using the “New NHP Applications Conversation” of the ePost Connect system rather than the “Application Review Conversation”.
Site license renewals should proactively provide an update on corrective and preventative actions implemented in response to GMP observations noted during the site license review. This will facilitate review of site license renewals where the issuance letters included Risk 2 and Risk 3 GMP observations.
In addition to the Site Licensing Guidance Document, the Good Manufacturing Practices Guidance and the Quality of Natural Health Products Guide should be consulted when preparing a site license application.
For product licenses, applicants should ensure that the application cover letter identifies which Class of application is being submitted. For Class III applications the cover letter should include the reason why the application has been deemed to be a Class III submission.
The correct web-based PLA form should be used to support product license applications based on the criteria provided by the NNHPD. Version 3 and Version 4 are available on the Health Canada website, Natural Health Product License Application Form to support applications
The NNHPD issues Information Request Notices (IRN) during review of both site license and product license applications if additional information or clarification is required to complete the review. All comments/requests within the IRN must be addressed when responding to the IRN in to avoid refusals or delays. When responding to an IRN, NNHPD suggests referencing the relevant IRN question number to facilitate review of IRN responses.
