On September 4, 2025, Health Canada released Version 4.0 of the Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs). This updated GMP guide takes effect on March 4, 2026. Until then, Version 3 remains in force and will continue to be referenced by inspectors.
If your business manufactures, imports, packages, or distributes NHPs, this update directly affects you. Understanding the changes in the new GMP guide is key to staying compliant, avoiding costly delays, and keeping your products on the market. Keep reading to see what’s new, why it matters, and how to prepare.
What Has Changed in Version 4.0
Health Canada clarified that Version 4.0 is not a new framework. Instead, it provides more prescriptive detail and clearer expectations across all GMP activities. These changes reflect Health Canada’s goal of improving quality assurance practices across the NHP sector. Key updates include:
- A new structure that follows the Natural Health Product Regulations
- Greater emphasis on company-wide quality systems and senior management accountability
- Expanded requirements for stability programs, corrective and preventive actions (CAPA), and recall systems (including mock recalls)
- More specific guidance for importers, including testing, documentation, and control of labels
- Detailed requirements for records management, including electronic systems, electronic signatures, and bilingual documentation (English or French)
- Clarification on reduced testing approaches and quantification by input, with stronger documentation requirements
Transition Timeline
The transition to Version 4.0 will not happen overnight. Health Canada has provided a defined period for businesses to adapt their systems and procedures.
- September 4, 2025 – March 4, 2026: Transition period. Companies should start reviewing and updating their procedures now.
- March 4, 2026: Version 3 will be retired, and Version 4 becomes the sole reference document for GMP compliance.
This six-month window is crucial. Businesses that fail to adapt risk non-compliance once inspectors fully enforce the new version.
Why This Matters for Your Business
Strong GMP systems are more than a regulatory requirement. They protect consumers, safeguard product quality, and reduce the risk of recalls or enforcement actions. With Health Canada placing new emphasis on management accountability and record-keeping, the responsibility is no longer limited to compliance teams; senior leadership must take an active role.
For importers and manufacturers, the updated GMP guide also highlights the importance of thorough documentation and bilingual records. This means you’ll need reliable systems and processes in place to meet expectations consistently.
Key Takeaways
- Version 4.0 of the GMP guide takes effect on March 4, 2026
- Expect more detailed requirements for quality systems, CAPA, recalls, and stability programs
- Importers face additional requirements for testing, documentation, and label control
- Stronger emphasis on records management, including electronic records and bilingual documentation
- Senior management is now explicitly accountable for GMP compliance across the company
GMP Guide FAQ
Is Version 4.0 a completely new framework
No. Health Canada confirmed that it’s not a brand-new framework. Instead, it provides clearer expectations and more detail to support compliance. Companies that are already following Version 3 will find the transition easier, but they will still need to update procedures and documentation.
Do small businesses need to follow the same requirements?
Yes. The GMP guide applies to all natural health product companies, regardless of size. Smaller businesses may face more challenges in adapting but are still expected to comply. This might mean investing in additional training or outsourcing some compliance functions to meet expectations.
When should my company start making changes?
Now. Although the new GMP guide will not be enforced until March 4, 2026, Health Canada encourages businesses to start transitioning immediately to avoid last-minute gaps. Early adoption also allows time for mock audits, system upgrades, and staff training.
Can I still use Version 3 of the GMP guide?
Only until March 4, 2026. After that, inspectors will refer exclusively to Version 4, so companies should not delay in aligning with the new requirements.
Where can I read the full GMP guide?
You can access the official Health Canada publication here.
Ready to Take Action?
The release of Health Canada’s GMP guide Version 4.0 marks an important step for the natural health product industry. While the changes bring new challenges, they also provide clearer pathways to compliance. Companies that prepare early will be better positioned to meet expectations, avoid enforcement risks, and maintain consumer trust.
Ready to make the transition smoothly? Alongside our NHP licensing services we also provide GMP training solutions to help your team build the knowledge needed to stay compliant. Get expert support from Quality Smart Solutions and let our regulatory specialists guide you every step of the way.
