Canada NHP Compliance Update: Ending the Foreign Site Reference Number Process and What It Means for Site Licence Holders

Health Canada has recently published a new bulletin under the Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin platform, announcing an important change related to foreign site references and foreign warehouses.

This update directly impacts Natural Health Product site licence holders, foreign manufacturers, and companies relying on foreign sites or warehouses as part of their Canadian supply chain.

The Health Product Compliance Directorate has clarified that the Foreign Site Reference Number process is being ended, signaling a shift in how Health Canada manages oversight of foreign sites associated with Natural Health Products. This change reinforces Health Canada’s move toward stronger compliance, traceability, and accountability within the NHP supply chain.

For companies holding or applying for a Natural Health Product Site Licence, this update highlights the importance of maintaining accurate, up-to-date site information and ensuring that all manufacturing, packaging, labeling, and importing activities remain fully compliant with Canadian GMP and site licensing requirements.

Foreign sites and warehouses play a critical role in the Canadian NHP market. With the end of the Foreign Site Reference Number process, site licence holders must reassess how foreign operations are referenced, documented, and supported within their licensing framework. Failure to align with updated Health Canada expectations may lead to compliance observations, inspection findings, or delays in licensing activities.

This bulletin also underscores Health Canada’s continued focus on risk-based inspections, GMP compliance, and clear communication between regulators and regulated parties. Site licence holders should proactively review their foreign site arrangements, supplier documentation, and quality agreements to ensure readiness for inspections and regulatory inquiries.

At Fiducia Globus, we support Natural Health Product companies, site licence holders, and international manufacturers with regulatory strategy, site licensing support, GMP compliance advisory, and inspection preparedness. Our team closely monitors regulatory updates and helps clients interpret and implement changes efficiently, minimizing compliance risk and business disruption.

As Health Canada continues to strengthen oversight of the NHP sector, staying informed and proactive is essential. Companies that adapt early to regulatory changes are better positioned to maintain uninterrupted access to the Canadian market.

For guidance on how this update may impact your site licence, foreign manufacturing arrangements, or compliance strategy, Fiducia Globus provides practical, regulatory-focused support tailored to your business needs.