Foreign Site Reference Number (FSRN)
What is a foreign site reference number(FSRN)?
A foreign site reference number (FSRN) is issued by NNHPD of Health Canada to a foreign site that manufactures, packages and/or labels natural health products outside of Canada meets the GMP requirements.
Who needs FSRN?
When applying for site licence, Canadian importers of natural health products are also required to obtain a FSRN authorization from the foreign manufacturer, packager and/or labeller of NHPs , to demonstrate that natural health products coming from that foreign site meet Canadian GMP requirements.
A separate application process is required in order to obtain the FSRN. The application must be accompanies by acceptable evidence of GMP compliance to adequately demonstrate the foreign site's ability to manufacture, package and/or label NHPs in accordance with the 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.
The FSRN is valid for a period of one or three years from the date of issuance, depending on the type of supporting GMP evidence provided in support of the foreign site.
The FSRN application
process will benefit foreign sites by:
- Allowing direct
communication between Health Canada and the foreign site, maintaining
confidentiality of the information provided;
- Saving time, money and
resources for foreign sites engaged with multiple Canadian importers by
eliminating the need to supply the site GMP information to each importer
several times a year. The FSRN is valid for a period of one year or three years
depending on the type of supporting GMP evidence provided in the application;
- Assessing the GMP compliance of a foreign site in advance, will also benefit the importer's subsequent site licence application. 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 as per section 3.1.1 of this guide.