NHPD has released two data extracts online. These data extracts consist of a comprehensive listing of Site Licence and Foreign Site Reference Number (FSRN) holders1.
In early August of this year the NHPD made available online two data extracts – one providing a comprehensive list of Site Licence holders, the other providing a comprehensive list of Foreign Site Reference Number (FSRN) holders. This development has been a long time coming, ever since the NHPD’s site licence database went off-line over five years ago, and should be welcomed news for the industry. Each data extract consists of the site name, address, activity types and site licence number or FSRN for domestic and foreign sites, respectively.
Having a comprehensive list of approved facilities means that a company wishing to source a contract manufacturer, packager, labeller, or importer, whether domestic or foreign, can readily verify whether or not a prospective vendor holds a valid Site Licence or FSRN. In the case of a domestic facility, holding a valid site licence means that the company’s quality system was assessed by the NHPD against the Canadian natural health products Good Manufacturing Practices (NHP GMPs) requirements and deemed to be compliant. Likewise, in the case of a foreign facility, holding an FSRN means that the facility was deemed to be compliant with the NHP GMPs or their equivalent. Implementing a quality system and preparing a Site Licence Application can be a potentially onerous undertaking, but having a vendor who is already approved may cut down on delays and uncertainties that can affect planned product launches
One, however, should be cautious when using the data extracts for several reasons. First, the databases do not provide the expiration date of the Site Licence or FSRN. Licences must be renewed in accordance with an established cycle and failure to renew will mean the cancellation of a licence. Second, the databases are updated only periodically and not in real time. Therefore, one may not be viewing the most up-to-date information concerning the site licence status of a particular company.
Bear in mind that not all approved foreign sites appear in the data extract. One, therefore, should not assume that an importer is not authorized to import from a particular manufacturer simply because the foreign site does not appear on the published list. All foreign sites must be annexed to an importer’s site licence; however, obtaining an FSRN is voluntary and is simply a way for a foreign site to obtain pre-approval of their GMP status. Some importers prefer to keep their manufacturers secret, particularly those who have invested a lot of time vetting their manufacturers and/or who invested time, effort and capital in helping them to become compliant with Canadian requirements. It is, therefore, understandable that these importers would prefer that their manufacturers not be listed as “approved” in a public database, even though the name of a manufacturer in the data extracts are never linked to a particular importer.
Nevertheless, the data extracts, like the online Product Licence Database, is a useful tool for industry to monitor its own status when it comes to complying with regulatory requirements.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com
References:
1. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-site-exploit/sl-list-le-eng.php