Health Canada's New Rules for Natural Health Products
Health Canada is rolling out major changes for Natural Health Products (NHPs) including new fees, labelling rules, and GMP updates starting in 2025. Eurofins Biopharma Product Testing Toronto, Inc. offers tailored solutions to help NHP companies navigate new Health Canada regulations efficiently and cost-effectively. Health Canada has updated its proposal for new fees, labeling requirements and Good Manufacturing Practices (GMP) for Natural Health Products (NHPs). These changes are designed to improve the safety, efficacy and transparency of NHPs for Canadians.
NEW FEES FOR NHPS
Health Canada has revised the initial proposal, targeting an implementation date of December 1, 2025 phased in over 7 years. Products authorized before June 21, 2025 have until June 22, 2028 to comply.
NEW LABELLING REQUIREMENTS
Effective June 21,2025 all new NHPs must comply with updated labelling standards. Key changes include:
- Product Facts Table: A standardized table providing essential information.
- Priority Allergen Labelling: Clear identification of allergens.
- Increased Font Size and Contrast: Improved readability.
- Modernized Contact Information: Inclusion of a website or other contact details.
GOOD MANUFACTURING PRACTICES (GMP) UPDATES
Health Canada has released a new draft GMP guide for NHPs, marking significant changes to ensure the safety and quality of products. The release of this update can be expected any time after Spring 2025. Key updates:
- Quality Risk Management (OOS, Deviations, Change control, CAPA)
- Expectations on Confirmatory testing program
- Requirements for the usage of “Quantification by input”
- Expectations on process validation
- Products imported from MRA-PIC/s (batch certification requirements)
- Details on Electronic signatures and Data integrity
Eurofins Biopharma Product Testing Toronto, Inc. Services
Improve Your Regulatory Compliance with Our Expert Services. We Offer Tailored Solutions Based on Recent Regulatory Changes:
- Site License Application (SLA) submissions
- Fee remission applications for small businesses
- Product License Application (PLA) submissions (Class I – III)
- Product Label Updates
- Product Facts Tables
- Allergen Labelling
- Check Readability
Improve Your Quality and Compliance with Our Expert Services. We Offer Tailored Solutions Based on Recent Regulatory Changes:
- QMS Assessment & Gap Analysis for improvement in line with QRM requirements.
- Testing Matrix Design for NHPs
- Data Governance Assessment
- NHP Product Database Reviewfor release requirements and compliance.
ACT NOW
In view of the upcoming fees, we encourage you to speed up your submissions to save on costs. Early submissions can help you take advantage before the new fees come into force.
Eurofins Biopharma Product Testing Toronto, Inc. is committed to supporting companies through this transition with customized regulatory and quality solutions. Whether you're updating product labels, submitting license applications, or strengthening your GMP framework, our team is here to help you navigate the changes confidently and cost-effectively.