What is a Foreign Site Reference Number: Guide to Compliance

By: Matthew Lai, REGULATORY SPECIALIST, email

A Foreign Site Reference Number (FSRN) is a valuable tool for foreign companies looking to sell their Natural Health Products in Canada. Issued to manufacturers, packagers, and/or labellers with operations based outside of Canada, an FSRN is recognized by Health Canada as pre-cleared Good Manufacturing Practices (GMP) evidence. This recognition simplifies the site licence application process and facilitates collaboration between licensed Canadian importers and foreign site owners. Canadian importers can reference the FSRN obtained by a foreign site, which allows them to show compliance with NHP regulations in a more efficient manner. By obtaining an FSRN, a foreign site can make a single application to Health Canada instead of submitting information for each importer, saving time and resources for the companies involved.

Our article provides a general overview of the Foreign Site Reference Numbers, their benefits, and ways to obtain one for your site.

Foreign Site Reference Number Overview

Foreign sites have the option to submit facility records and procedure documents to the Natural Health Products Directorate (NNHPD) in a “New FSRN Application.” These applications include the specific activities associated with their physical site, including manufacturing, packaging, and labelling. For instance, any foreign site that labels natural health products can pre-register with an FSRN for that activity before working with a Canadian importer.

If foreign sites plan to work with homeopathic medicines or sterile products in Canada, they must provide acceptable evidence related to the manufacture of these product types to Health Canada. Health Canada will then review the GMP documentation and assess whether the site complies with Canadian Natural Health Product regulations.

If the foreign site can adequately demonstrate that they meet GMP requirements, Health Canada will provide a Notice of Acceptance, which will have the Foreign Site Reference Number assigned to the physical site. This indicates that the foreign site was found to be in compliance with Natural Health Product Regulations. This would then be considered as pre-cleared evidence by Health Canada when the FSRN is referenced in a Canadian site licence application. Some benefits of this include a shorter review period and a lesser number of documents needed in the initial site licence application.

Foreign companies with a Foreign Site Reference Number can more easily collaborate with Canadian importers. Obtaining an FSRN removes the need for foreign sites to share all documentation associated with their activities. Since information is submitted to Health Canada during the FSRN application review process, foreign sites can simply provide an authorization letter instead of an extensive list of documents to their Canadian partners. This FSRN Authorization form, signed by the Senior Official of the foreign site, grants permission for the Canadian site licence applicant to reference the Foreign Site Reference Number and the information submitted to Health Canada. This, in turn, allows Health Canada to access the documents submitted by the foreign site applicant internally, helping the foreign site maintain confidentiality by limiting the information shared with the Canadian importer.

Site Licensing and FSRNs

In all cases, Canadian companies interested in working with Natural Health Products (NHPs) must obtain a site licence. This licence is required for companies that manufacture, package, label, or import NHPs for sale. During the site licence application or amendment process, Canadian sites must obtain Good Manufacturing Practices (GMP) evidence from the foreign companies supplying the products for import into Canada.

If the foreign site already has a Foreign Site Reference Number (FSRN), the Canadian company can reference this number in their site licence application. By providing the FSRN along with an authorization letter from the holder, the Canadian company can avoid submitting the GMP evidence itself during the site licensing process. Once the Canadian company obtains a site licence and adds the foreign manufacturer, they can import and sell NHPs manufactured outside of Canada.

At the time of writing, Health Canada will only accept FSRN-related applications if they are linked with a Canadian site licence application due to their interim measures. If a foreign site owner wishes to submit a FSRN application, there must be a Canadian site licence holder working to add this foreign site before the application is reviewed by Health Canada.

Obtaining a Foreign Site Reference Number

To obtain a Foreign Site Reference Number (FSRN), a “New FSRN Application” must be completed and submitted to Health Canada for review as a part of the FSRN application process. Alongside the application, foreign site owners must provide evidence of Good Manufacturing Practices (GMP) compliance. This evidence can include a Drug Establishment Licence (DEL) or an audit report on dietary supplement manufacturing from a Qualified Authority (such as the NSF or FDA). Additional documents may include examples of finished product and stability testing, demonstrating the use of pharmacopeial methods outlined in the United States or European Pharmacopoeias.

Once the necessary documentation is provided, Health Canada will review the application and supporting evidence. If approved, the FSRN will be issued and will remain valid for one or three years from the date of issuance, depending on the type of GMP evidence provided.

Summary of FSRNs

In summary, Health Canada offers FSRN registration for foreign sites interested in collaborating with Canadian business partners to bring their Natural Health Products to the Canadian market. Like all foreign sites, FSRN holders must regularly provide GMP evidence to Health Canada to demonstrate compliance with Canadian requirements. However, the FSRN registration makes it easier for foreign site owners to work with multiple Canadian importers and simplifies the site licence application process.

Site licensing is essential for selling natural health products in Canada, for both local and foreign companies. At Dell Tech, our experts guarantee a smooth process to secure your site licence or Foreign Site Reference Number, ensuring full compliance with Natural Health Product Regulations. Contact us today to get started!

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