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Health Canada's FPS Submission Change: 5 Steps NHP Companies Should Take Now
Antonella Maggio
Health Canada's recent update to the Natural Health Product (NHP) licensing process has reduced one administrative requirement for Class II and Class III applications: Finished Product Specifications (FPS) no longer need to be submitted as part of the initial license application package.
While this change may simplify submissions, it should not be interpreted as a reduction in regulatory expectations. Manufacturers remain fully responsible for establishing, maintaining, and providing product specifications when requested by Health Canada.
What Has Changed?
Previously, applicants submitting certain NHP license applications were required to include Finished Product Specifications with their submission.
Under the revised process, these specifications are no longer routinely submitted at the time of application. However, Health Canada may still request FPS documentation during application review, compliance activities, inspections, or post-market assessments.
The regulatory expectation surrounding product quality has not changed - only the timing of document submission has. For NHP companies, now is an ideal time to evaluate internal quality systems and ensure documentation practices remain inspection-ready.
Why Finished Product Specifications Remain Critical
Finished Product Specifications define the quality attributes a product must meet before release to market. They establish acceptance criteria for elements such as:
- Identity and potency of medicinal/active ingredients
- Purity requirements
- Microbial limits
- Contaminant thresholds
- Physical and chemical characteristics
- Applicable analytical methods
- Specific test methods/acceptance criteria pertaining to non-medicinal ingredients
Robust specifications provide documented evidence that products consistently meet established quality standards and support ongoing compliance with Good Manufacturing Practice (GMP).
5 Actions NHP Companies Should Take
- Continue Developing FPS Early in Product Development
Although FPS documents no longer accompany initial submissions, organizations should still develop specifications during product development - not after Health Canada requests them.
Waiting until a regulatory request is received can lead to delays, resource strain, and gaps in supporting documentation.
- Review Existing Specifications for Completeness
Companies should assess whether existing specifications accurately reflect current formulations, manufacturing processes, and analytical methodologies – to ensure that the product risk profile is holistic and understood. As such, outdated specifications may create compliance risks during inspections or regulatory reviews.
- Strengthen Supporting Documentation
An FPS is only as strong as the evidence supporting it. Analytical data, method validation/verification reports, certificates of analysis, and stability information should be organized and readily accessible.
Health Canada may request supporting records to substantiate specification limits and testing approaches.
- Ensure Inspection Readiness
As regulatory oversight continues to evolve toward risk-based approaches, maintaining inspection readiness remains essential.
Organizations should periodically evaluate whether manufacturing traceability, data integrity, documentation systems, and quality records can be retrieved efficiently if requested.
- Evaluate Quality Systems Holistically
This regulatory update provides an opportunity for companies to review broader quality management practices, including:
- Change control procedures
- Supplier qualification programs
- SOP management
- CAPA processes
- Internal audit programs
- GMP compliance systems
- Risk management
Strong quality systems support both regulatory compliance and long-term business success.
Industry Perspective
Health Canada's updated approach reflects a broader regulatory trend: reducing unnecessary administrative burden while maintaining expectations for product quality and compliance.
For the industry, this means that fewer submission requirements do not equate to reduced accountability. Organizations with mature quality systems and well-maintained documentation will be best positioned to respond efficiently to regulatory requests and inspections.
The Bottom Line
The elimination of routine FPS submission may streamline the NHP licensing process, but companies should resist viewing the change as a relaxation of quality requirements.
Product specifications remain a foundational element of compliance. Maintaining accurate, scientifically justified, and inspection-ready documentation remains essential for bringing and keeping products on the Canadian market.
About the Author
Antonella Maggio 
Program Director, Quality Services
With more than 25 years of cross-functional experience in quality and compliance, Antonella has contributed across the pharmaceutical, biotechnology, consumer health, cosmetic, dietary supplement/natural health product, and medical device sectors. Her career spans a range of leadership and advisory roles focused on the implementation, optimization, and continuous improvement of Quality Management Systems.
Throughout her career, Antonella has guided teams through complex compliance and remediation initiatives, helping organizations navigate regulatory challenges, strengthen operational frameworks, and establish sustainable quality practices.
She has been an active member of the Parenteral Drug Association since 2009 and joined the Regulatory Affairs and Quality Advisory Board (RAQAB) in 2025. Antonella holds a Certified Quality Auditor (CQA) credential, along with several additional industry certifications that reflect her extensive expertise and commitment to the field. She also holds a Bachelor of Science degree and an MBA.
In her role as Program Director, Quality Services, Antonella combines deep technical expertise with a forward-thinking business perspective to support clients in achieving and maintaining quality excellence.
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