In October 2024, Health Canada launched a consultation to update the 2015 Good Manufacturing Practices (GMP) Guidance Document (Version 3.0). That draft focused on simplifying language, aligning with international quality system principles, and introducing flexibility for small and medium-sized enterprises.

On September 4, 2025, Health Canada published the finalized Good Manufacturing Practices Guide for Natural Health Products (GUI-0158, Version 4.0). This 165-page guide comes into force on March 4, 2026, and replaces Version 3.0. While the draft set the stage, the final guidance introduces new obligations and clarifications that will have a significant impact on companies operating in the NHP sector.

Scope and Purpose

The updated guidance interprets Part 3 of the Natural Health Products Regulations and applies to all activities related to NHPs, including manufacturing, packaging, labelling, importing, distributing, storing, testing, and holding a product licence.

The scope covers both non-sterile NHPs—such as enzymes, probiotics, amino acids, herbal remedies, vitamins, minerals, traditional medicines, and certain personal care products like toothpastes, antiperspirants, shampoos, and mouthwashes—as well as sterile NHPs, including ophthalmic products and sterile water for irrigation.

Although distribution and storage are not licensable activities under Part 2 of the regulations, the new guidance makes clear that GMP requirements must still be followed when these functions are carried out by importers, warehouse operators, or e-commerce distributors.

What Are the Changes?

Version 4 incorporates feedback from the 2024 consultation while adding substantial new requirements. Key updates include:

• Clearer expectations for quality systems, with a required quality manual, defined management roles, and active involvement from senior or executive management.
• Expanded applicability of GMP across the supply chain, with distributors and storage facilities now explicitly covered.
• A strengthened role for the Quality Assurance Person (QAP), who must review and approve each batch of NHPs before release.
• Broader and more detailed record-keeping obligations for manufacturers, packagers, labellers, importers, and distributors, ensuring traceability across the entire product lifecycle.
• Clarifications on finished product testing, which is now positioned as an integral element of product release.
• More detailed stability period requirements to demonstrate that NHPs remain compliant through their shelf life.
• A dedicated supplementary section addressing GMP requirements for homeopathic medicines.
• Expanded guidance on risk classification and the Corrective and Preventive Action (CAPA) process, emphasizing the use of science-based quality risk management tools such as those found in the ICH Q9 Quality Risk Management – Scientific Guideline.

Taken together, these changes represent more than refinements—they signal a fundamental shift in how compliance will be assessed. For many companies, especially those with complex supply chains or smaller operations, the breadth of new expectations may feel overwhelming.

How to Be Prepared

With the compliance date set for March 4, 2026, companies have a defined transition period to adapt—but the scale of the changes means that action should begin now. Practical steps include:

• Conducting a full gap assessment against the requirements in Good Manufacturing Practices Guide for Natural Health Products (GUI-0158, Version 4.0.
• Updating or developing a comprehensive quality manual that defines management roles, responsibilities, and accountability.
• Engaging senior leadership to ensure adequate resources and oversight are in place to support compliance.
• Reviewing and strengthening supplier qualification, monitoring, and oversight programs.
• Enhancing record-keeping systems to ensure full traceability, including batch records, importer documentation, distributor records, and recall reporting.
• Implementing or updating stability testing programs to verify quality throughout product shelf life.
• Integrating formal quality risk management practices and ensuring CAPA processes are robust and well documented.

For many organizations, particularly small and medium-sized enterprises, the scope of these requirements may feel overwhelming. The transition period is short in regulatory terms, and preparation will require significant planning and resources.

Get Expert Advice

The finalization of Version 4 of the GMP guidance marks a new era for NHP compliance in Canada. The updates go beyond simple clarifications—this is a redefinition of how GMP and quality systems will be assessed and enforced across the industry.

dicentra has completed over 24,000 projects in regulatory and quality compliance. We support NHP companies with site licensing, NPN applications, GMP audits, and quality system design. Our expertise ensures that your operations are not only compliant with the new guidance but also positioned for long-term success in the Canadian market.

If you would like to understand what these changes mean for your business and how to prepare effectively, connect with us today.