When foreign facilities manufacture, package, or label Natural Health Products (NHPs) for the Canadian market, Health Canada requires proof of Good Manufacturing Practices (GMP) compliance. To simplify this process and reduce administrative duplication, the Natural and Non-prescription Health Products Directorate (NNHPD) issues a Foreign Site Reference Number (FSRN).
An FSRN acts as pre-cleared GMP evidence that Canadian importers can reference in their site licence applications. It protects confidential information, streamlines regulatory compliance, and provides foreign manufacturers with a competitive advantage when supplying NHPs to Canada. This post provides an executive overview of FSRNs, including their purpose, application process, benefits, and common pitfalls to avoid.
What is an FSRN?
A Foreign Site Reference Number (FSRN) is a unique identifier assigned by Health Canada’s NNHPD to non-Canadian facilities that manufacture, package, label, or warehouse NHPs. It confirms that the site has been assessed and found compliant with Part 3, Good Manufacturing Practices (GMP), of the Natural Health Products Regulations.
Unlike a site licence, an FSRN does not authorize direct export of products to Canada. Instead, it serves as a reference number demonstrating that the foreign facility meets Health Canada’s GMP standards. Canadian importers must hold a valid site licence that includes the foreign site to legally import NHPs.
Why is an FSRN Important?
Before importing NHPs into Canada, Canadian companies must demonstrate that the foreign sites supplying their products meet GMP requirements. Traditionally, each importer would submit duplicate GMP evidence for every foreign site. The FSRN simplifies this process by allowing multiple importers to reference a single, pre-cleared GMP evaluation, reducing administrative burden and protecting confidential information.
For foreign manufacturers, holding an FSRN signals compliance and reliability, making them preferred partners for Canadian importers. It also enables direct communication with Health Canada, facilitates faster review timelines, and supports long-term market access.
Benefits of Obtaining an FSRN
- Pre-cleared GMP Evidence: Canadian importers can reference the FSRN in site licence applications, eliminating duplicate submissions.
- Confidentiality: Sensitive site information, such as manufacturing processes or quality systems, remains protected.
- Reduced Administrative Burden: Especially beneficial for foreign sites supplying multiple Canadian importers.
- Faster Processing: Site licence applications referencing a valid FSRN are generally subject to shorter service standards.
- Competitive Advantage: Importers prefer working with sites that have validated GMP compliance.
FSRNs are typically valid for one year when based on a Quality Assurance Report (QAR) or three years when supported by pre-cleared GMP evidence. Maintaining an up-to-date FSRN ensures continued compliance and uninterrupted market access.
Application Process
Foreign facilities can apply for an FSRN directly through Health Canada’s online system, WebSLA, or ePost Connect. Linking the FSRN application to an active Canadian site licence improves prioritization and review speed.
Step 1: Obtain a Company Code
Each company must first obtain a unique five-digit company code from NNHPD. This code identifies the company in Health Canada’s system and is required on all applications.
Step 2: Complete the Application Form
Foreign sites submit the official FSRN application form, detailing activities such as manufacturing, packaging, labelling, or warehousing. The form should clearly indicate product types handled, including sterile, non-sterile, or homeopathic products.
Step 3: Prepare Supporting GMP Documentation
Applicants must provide GMP evidence demonstrating compliance with Canadian regulations. Accepted documentation may include:
- Quality Assurance Reports (QARs)
- Certificates from recognized GMP authorities
- Standard Operating Procedures (SOPs)
- Batch and inspection records
- Training and quality system documentation
Incomplete or outdated documentation is the most common cause of delays or refusals.
Step 4: Submit and Track the Application
Once complete, applications are submitted electronically through ePost Connect. Health Canada may request additional information, which must be provided promptly to avoid delays.
Step 5: Approval and Issuance
Approved sites are assigned an FSRN, which can then be referenced by Canadian importers in their site licence applications.
Step 6: Renewal and Maintenance
FSRNs are not permanent. Renewal is required to maintain validity, with timelines dependent on the type of GMP evidence submitted. Regular updates, including amendments for operational changes and minor notifications, are essential for continuous compliance.
Renewals, Amendments, and Notifications
Renewals:
- Required to demonstrate ongoing GMP compliance.
- Must be submitted at least 30 days before expiry, although early submission is recommended.
- FSRN validity: 1 year (QAR-based) or 3 years (pre-cleared GMP evidence).
Amendments:
- Necessary for significant changes such as adding new activities, relocation, or introducing sterile manufacturing.
- Requires updated GMP documentation and notification to Canadian importers.
Notifications:
- Minor updates like legal name changes, new contact information, or minor process adjustments can be submitted as notifications within 60 days.
- Keeps Health Canada records accurate without full reassessment.
Common Pitfalls
Incomplete Documentation
Missing audit reports, unsigned agreements, or outdated SOPs can delay or reject applications.
Inconsistent Site Information
Legal names, addresses, and activities must match exactly across all documents.
Insufficient Activity-Specific Evidence
GMP evidence must cover each activity performed at the site.
Using Outdated Forms
Ensure all forms, cover letters, and authorizations are current.
Avoiding these pitfalls ensures smoother Health Canada review and reduces delays.
Final Remarks
A Foreign Site Reference Number (FSRN) is a critical tool for Canadian importers and foreign manufacturers of NHPs. It provides pre-cleared GMP evidence, protects confidential information, streamlines compliance, and supports uninterrupted market access.
Success with FSRNs depends on accuracy, preparation, and timeliness. Maintaining up-to-date documentation, managing renewals, and proactively addressing amendments and notifications are essential for compliance and operational continuity.
Need Support?
At Source Nutraceutical Inc. (SNI), we help brands navigate Canadian regulatory requirements with confidence. With over 20 years of experience supporting natural health products, foods, cosmetics, medical devices, and pet products, our team provides tailored guidance for FSRN submissions and renewals, site licence applications, clinical trials and evidence generation, as well as compliant labelling and packaging.
Whether you are an emerging start-up or a global brand, SNI delivers the regulatory expertise, clinical knowledge, and creative services needed to launch, grow, and expand in Canada.
✔️ More about our services here.
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Learn more about FSRNs in our detailed blog here.
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