Health Canada Updates Site License Holders List

Two important lists regarding the manufacture and import of natural health products into have been updated on the Health Canada website.
The first list, the Site License Holders List, provides information on those facilities located in Canada that have received approval by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) for the following activities related to natural health products (dietary supplements):
○ manufacturing
○ packaging
○ labelling
○ importing
The second list, the Foreign Site Reference Number Holders List, provides a listing of reference numbers for buildings located outside of Canada that may be able to export their natural health products (NHPs) into one of the approved import sites located within Canada.
In order to receive an FSRN, foreign groups may file their application directly to Health Canada’s NNHPD. This application would consist of evidence that the building for which a license is sought complies Part 3 of the Natural Health Product Regulations (GMPs). Once Health Canada receives an FSRN application by foreign applicants, a reference number will be assigned to the foreign building. This number can then be used by importers in their amendment applications to add that same foreign manufacturer.
One pitfall to be wary of is partially approved FSRNs. While Health Canada may provide foreign applicants with a reference number for use in association with a designated importer, there may still be some outstanding items to be provided by the foreign group in order for them to be recognized as fully compliant with good manufacturing practices. These outstanding items frequently centre around finished product testing and stability testing, both of which require attention by applicants in order to receive Health Canada approval of amendments to add foreign suppliers of NHPs.
It is therefore crucial for groups entering into supply relationships for Canada to understand whether or not there are any outstanding items as a result of the FSRN application process. By investigating these deficiencies at the outset of business relationships, the likelihood of approval of an importers application to start importing from their chosen export site will be greatly increased. Failure to address deficiencies identified during review of FSRN applications will result in delay of Health Canada approval.
Note a facility outside of Canada can not apply to be a site license holder. Only those facilities located in Canada may apply for a site license. Both lists can be read at the following link: