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, 2026, may be one of the most significant revisions to the program since the introduction of The Natural Health Product (NHP) Regulations in Canada.

Finished product specifications, which refer to quality testing for purity, level of ingredients and other product attributes, have been historically required for Class II and Class III product license applications. Submission of FPS at the development stage can be challenging for some applicants, as the details of the program may not yet be finalized at the time of application. As a result, the finished product testing program may be revised during regulatory review and during marketing of the product in Canada. Revisions to the FPS would trigger the requirement to file an amendment, increasing regulatory burden. The removal of the FPS requirement for Class II and Class III product license amendments will result in reduced regulatory filings and delays.

In the Bulletin, Health Canada reminds licence holders and applicants that a request for FPS may be issued for any NHPs at any time. A risk-based approach will be in place to guide these decisions and requests, as there is wide variation in product types and safety profiles of natural health products.

Finished product specifications continue to be required with site license applications however. Providing details of the FPS program including test methods and tolerance ranges are required as evidence that NHPs will be tested according to Good Manufacturing Practices. Although product license holders will no longer be required to submit FPS with product license applications, they are still responsible for the safety and quality of their natural health products. When working with another organization responsible for manufacturing and testing, written agreements and close collaboration regarding the FPS program will support ongoing compliance, and will ensure products manufactured and distributed in Canada are identical to those registered under the current product license.