Site Licence and Foreign Site Reference Number
Site Licence
For any Canadian companies that are involved in manufacturing, packaging, labelling, or importing a Natural Health Product (NHP) for sale, a Site Licence is required.
Issued by Natural and Non-prescription Health Products Directorate (NNHPD), the purpose of the Site Licence is to ensure the site is known to Health Canada and is in compliance with the Good Manufacturing Practices (GMP).
This Site Licence even applies to importers that ship products directly to any sort of retailers (e.g. Amazon Canada) without first storing the products themselves. Amazon’s policy now mandates all NHPs that are sold through its platform to comply with regulations set by Health Canada.
Foreign Site Reference Number (FSRN)
A foreign site reference number is issued by NNHPD of Health Canada to a foreign site that manufactures, packages and/or labels natural health products outside of Canada that can meet GMP requirements.
Once issued a FSRN, foreign site owners may authorize Canadian importers to reference their FSRN as an alternative to providing GMP evidence for their site.
A FSRN is considered pre-cleared evidence when referenced in support of an importer's Site Licence applications, and is therefore subject to a shorter service standard for the Site Licence application. Having a FSRN could easily make you the preferred supplier among all your competitors.
Obtain a Site Licence or Foreign Site Reference Number
We have helped clients in preparing NHP and FSRN license applications to assure they can comply with the regulations and GMP.
Our consultants will assist you with all aspects of natural health product site licensing, including:
Prepare Quality Assurance Reports
Apply for a new Site Licence/FSRN
Renew or amend your existing Site Licence/FSRN
Improve and Complie evidence of GMP-compliance for your site
Conduct on-site GMP Audit