COVID-19 Interim Site License Transition

In March 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) introduced interim measures to enable expedited site licensing for alcohol-based hand sanitizers. As of August 2020 the NNHPD stopped accepting new site license applications under the expedited regulatory pathway. NNHPD also indicated that moving forward, any site licenses issued under the interim measures would no longer be valid after a 60 day notice by the NNHPD.

In July of 2021, NNHPD communicated to all interim COVID-19 site licence holders (licences denoted by the prefix “COV####”) that they are required to submit a complete application for a site licence by September 30, 2021 in order to continue activities beyond that date.

If you’ve received communication from the Natural and Non-prescription Health Products Directorate regarding the upcoming expiry of your site licence, the transition to full site license holder should be started in order to meet the application deadline of September 30, 3021 at midnight. Those that do not file an application will be required to cease manufacturing, packaging, labelling and/or importing activities with respect to NHPs by that date. Health Canada may undertake compliance actions to ensure that activities have ceased.

When applying for a full site license, the most recent version of the web SLA form should be used, which now includes a choice for “COVID-10 SL Transition” on the first page of the form. Applicants should complete and submit an .html version of the SLA form, in addition provide evidence of their compliance with Good Manufacturing Practices (GMPs) requirements outlined in Part 3 of the Natural Health Product Regulations.