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Foreign Site Reference Number (FSRN) Interim Measures

For natural health products (NHPs) manufactured, packaged and/or labelled by sites located outside of Canada, Canadian importers are required to provide evidence that these sites will be at par with Canadian Good Manufacturing Practices (GMP) under Part 3 of the Natural Health Products Regulations (NHPR). <br>https://qualitysmartsolutions.com/nhp-licensing-and-consulting-experts/<br>https://qualitysmartsolutions.com/gmp-training/

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Foreign Site Reference Number (FSRN) Interim Measures

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  1. Foreign Site Reference Number (FSRN) Interim Measures (26 April 2022)

  2. Who needs FSRN? Who needs FSRN? For natural health products (NHPs) manufactured, packaged and/or labelled by sites located outside of Canada, Canadian importers are required to provide evidence that these sites will be at par with Canadian Good Manufacturing Practices (GMP) under Part 3 of the Natural Health Products Regulations (NHPR). Foreign sites can be added to site licence application of Canadian importers by providing GMP evidence from the foreign site. Foreign Site Reference Number (FSRN) helps in eliminating the need of a foreign site to provide same GMP evidence multiple times for each importer’s Site License. It is important to note that a Foreign Site Reference Number is not a site license and hence cannot be regarded as an authorization for direct export of NHPs to Canada.

  3. Impact of interim measures on new Foreign Site Reference Number (FSRN) Applications § New FSRN applicationswill beonlyreviewed upon annexation submission. Application for FSRN will be refused if not linked to a Canadian Importer. Previously FSRN submissions were reviewed and approved as their own application. § Now foreign sites must be linked to a Canadian importer upfront. Previously lower priority was placed on Foreign Site Reference Number (FSRN) applications that did not link to an importer’s site license. Now there is no mention of priority.

  4. Impact of interim measures on Foreign Site Reference Number Renewal Application • FSRN will be extended until further notice if the site has been inspected by a qualified authority in the last 5 years (e.g., FDA) and that there have been no risk issues flagged by a recognized authority (e.g., FDA). FSRNs that were issued based on QAR or SNC since 2020 (to 2023) will also be extended. • FSRN holders are required to notify the NNHPD if there are any changes to site’s GMP that may cause a risk to health, such as a regulatory action. • Each FSRN will be re-reviewed when it is included/linked to a new importer’s submission to ensure there is no risk associated with the site. Previously FSRN sites having expiry dates were required to be renewed prior to that date.

  5. Impact of interim measures on modifications to an existing Foreign Site Reference Number • When submitting changes to FSRN, the information will only be evaluated (in parallel) when the change is also submitted/ initiated by an importer or site license holder. Previously FSRNs were updated and reviewed without being triggered by a site license amendment.

  6. Working with a third-party consultancy • www.qualitysmartsolutions.com • www.NHPLicenseExperts.com • www.QualityIMPORTSolutions.com • www.CannabisLicenseExperts.com 1.800.396.5144

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