In attempt to eliminate the recent issue of site license renewal backlogs, the Natural and Non-Prescription Health Products Directorate (NNHPD) is implementing a new risk based approach to the site license application. With an ambitious goal of removing all backlog by December 1st of this year, the NNHPD created a detailed and well-structured three step plan.
The first of these three stages involves introducing a new web form for all site license applications. The NNHPD is planning to launch the new version of the form on November 12, 2020, implementing a 1-2 week grace period, after which all old versions of the web form will be removed. It should also be noted that due to current on-site limitations cause by the COVID-19 pandemic, the NNHPD has also been requesting that applicants using the paper submission method resubmit their application using the electronic system in order to lessen any delays as much as possible.
In addition, in cases of foreign sites that have no identified risk issues, the NNHPD will “align with the Regulatory Operations and Enforcement Branch (ROEB)’s approach for Finished Dosage Form Foreign Building compliance by extending the authorization period of foreign sites until further notice (or until reviewed by Health Canada)”. Foreign site applications that are not linked to at least one importer or where there is no inspection evidence are being considered low priority for the time being and will not be reviewed within NNHPD’s current service standards.
Lastly, NNHPD has a plan to implement operational efficiencies for sites with no known risk issues. NNHPD will now take a risk-based approach to its review of renewals for sites that were recently renewed and have no known compliance issues. However, it is important to note that, as per usual, “should a risk to health be identified subsequent to the renewal, Health Canada may take compliance action, which may include such actions as the issuance of an intent to suspend or immediate suspension of the site license, as deemed appropriate”.
Other key reminders that the NNHPD is asking applicants to keep in mind during this transition process include, for site licenses set to expire post December 1st, an application to renew the license is required at least 30 days before its expiry date. Furthermore, if an application is not received by the NNHPD to renew a site license by December 1st (for those sites that were extended until December 1st), the site will not be renewed. For more information regarding these upcoming changes and the site license application and renewal processes, visit the Health Canada website.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.
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