Who needs a Foreign Site Reference Number (FSRN)?
For Natural Health Products (NHPs) manufactured, packaged, and/or labeled 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).
This can be demonstrated using pre-cleared pieces of evidence or other acceptable evidence by the Site Licensing Guidance document. Foreign sites can be added to the site license application of Canadian importers by providing GMP evidence from the foreign site. This evidence is intended to demonstrate that manufacturing, packaging, and/or labeling operations carried out at foreign sites are in accordance with Part 3 of the NHPR.
FSRN thus helps in eliminating the need for a foreign site to provide the 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 authorization for the direct export of NHPs to Canada.
In a recently issued 4-page bulletin, the Natural and Non-prescription Health Products Directorate (NNHPD) has advised stakeholders regarding the interim measures on new Foreign Site Reference Number applications and renewal/modification of existing FSRNs. This bulletin also sheds light on interim measures for the validity of the Foreign Site Reference Number. If your FSRN meets certain criteria, you may be eligible for a longer validity period (extension).
- New Foreign Site Reference Number Applications – These applications will be reviewed upon annexation submission. Application for FSRN will be refused if not linked to a Canadian Importer. This measure is effective until further notice. Approval in the form of a Notice of Acceptance (NOA) will be issued if these conditions are met and the site is compliant. Previously FSRN submissions were reviewed and approved as their own application. Now the Foreign site must be linked to a Canadian importer upfront. Previously lower priority was placed on Foreign Site Reference Number applications that did not link to an importer’s site license. Now there is no mention of priority.
2. 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 there have been no risk issues flagged by a recognized authority (e.g., FDA). FSRNs that were issued based on QAR or SNC from 2020-to 2023 will also be extended.
FSRN holders are required to notify the NNHPD if there are any changes to the 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.
3. 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.
As per these interim measures, the Foreign Site Reference Number holder is responsible for the following:
- Providing FSRNA (authorization) form to each Canadian importer
- Providing required records to site license holders in a timely manner
- Providing required records at the time of site license submission, annexation, and renewal
These requirements are the same as earlier and there are no changes to previous requirements.
According to the interim measures, the Site License holder’s (Canadian Importer) responsibilities include:
- Finished product testing and stability studies are conducted in accordance with Part 3 of NHPR and the relevant records are held by the importer
- Ensuring that records are available from Foreign Sites in one of the official languages (i.e., English and/or French)
- Ensuring that relevant records for production and quality such as Master production documents, recalls, complaints, etc. are retained and readily available
Planning is a critical component of any site licensing activities; hence it is crucial to keep abreast with the impacts of these changes to the plans for your products, sites, and their operational activities. Our experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, Natural Health Products, NHP Site Licensing, OTC drugs, and medical devices for North America.