If you would like to receive a Site License for natural health products you must operate in compliance with Division 3 of the Natural Health Product Regulations (which pertain to Good Manufacturing Practices), and you must be located in Canada. While this precludes any group outside of Canada from actually receiving their own site license, interested parties may still be able to demonstrate their GMP compliance to Health Canada by making use of the Foreign Site Reference Number system of Health Canada.
The foreign site reference number (FSRN) is a natural first step for any group looking to export their natural health products and dietary supplements to Canada.
Here’s the answers to some frequently asked questions on the FSRN process:
Q. How does a manufacturing group, packager or labeller apply for a foreign site reference number?
A. An application can be made directly to the Natural and Non-Prescription Health Products Directorate of Health Canada.
Q. How long does it take to receive a foreign site reference number?
A. That depends on the type of GMP evidence submitted, but approval can be received in as little as 30 days after an application is submitted.
Q. Will any other party be able to view the applications?
A. Health Canada maintains confidentiality of all information provided. A Canadian designate is not required to submit this information on your behalf.
Q. What are the advantages of having an foreign site reference number?
A. You will be a more attractive partner and a sought-after exporter for those groups in Canada wishing to import natural health products. Once a foreign site receives their reference number, the number can be used immediately to support any Canadian importer site license application.
Q. How long is a foreign site reference number valid for?
A. One to three years, depending on the type of evidence submitted with your foreign site reference number application.