Health Canada has released a new bulletin clarifying its updated expectations for Finished Product Specifications (FPS) submitted in support of Natural Health Product (NHP) licence applications. Starting June 25, 2026, it will no longer be required to submit an FPS with Class II and III product licence applications (PLAs) and amendment applications.
The purpose of this decision is to reduce the administrative burden posed by these forms and harmonize the FPS approach across all PLA classes (Note: FPSs do not need to be submitted with Class I PLAs and amendments), while at the same time serving as a reminder that FPS are still a critical component of demonstrating product quality and regulatory compliance.
Key Takeaways for Industry
- No FPS component with Class II and III submissions (starting June 25th)
- FPS only changes (post-licence) do not have to be submitted to Health Canada
- FPS must be available upon request during an application review
- requests will be limited to risk‑related quality issues (e.g. cannabis‑containing NHPs)
- requests will come in the form of an Information Request Notice (IRN)
What This Means for Licence Holders
Manufacturers and licence holders should continue to review their FPS documents to ensure they remain compliant with current guidance and accurately reflect how product quality is controlled throughout the product lifecycle. Particular attention should be paid to potency specifications, assay strategies, and justification for any reliance on input-based quantification.
This action does not change NHP Good Manufacturing Practices (GMP) requirements and as Health Canada continues to focus on product quality and regulatory compliance, robust Finished Product Specifications remain a key element of a successful NHP submission. Companies preparing new applications or managing post-licensing quality changes should proactively assess their specifications to minimize regulatory delays and reduce the risk of information requests during review.
Blog Author
Madelyn Martinez, H.BSc.
Madelyn Martinez is a Regulatory Affairs Specialist with nearly 7 years of experience in regulatory consulting. She specializes in natural health products, cosmetics, and food regulations, with a strong background in public health and policy.
