How Long is My COVID-19 NHP Site License Valid?
By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
Many manufacturers and importers of Alcohol-based Hand Sanitizers continue to manufacture under a Temporary COVID-19 Site License (SL). This is still perfectly acceptable and, as of today, there is no indication of this changing. If and when it does change, Health Canada will provide all temporary COVID-19 Site License holders with a 60-day advanced notice of when temporary COVID-19 Site Licenses will be deemed no longer acceptable. At that time, temporary COVID-19 Site License holders will have two options:
1. DISCONTINUE Natural Health Product (NHP) ACTIVITIES:
If your company does not want to continue the activities covered by the temporary COVID-19 Site License you need to relinquish your COVID-19 Site License within 60 days of the notice date. In doing so, you will be required to confirm that you have ceased all activities previously authorized under the temporary COVID-19 Site License.
2. CONTINUE Natural Health Product (NHP) ACTIVITIES:
If your company wants to continue the activities covered by the temporary COVID-19 Site License you need to submit a completely new application for a site license in full compliance with the Natural Health Products Regulations (NHPR) within 60 days of the notice date. You may submit an application to the Natural and Non-prescription Health Products Directorate (NNHPD) in advance of receiving the notice; however, a licensing decision may not be issued to you within our usual service standards (35 – 65 days). If Health Canada refuses to issue you a new site license, activities must cease immediately upon receipt of the decision. If you take no action (neither 1 or 2), you are expected to cease all activities under the temporary COVID-19 Site License by the end of the 60-day notice period. Health Canada will initiate follow-up action to ensure you have ceased all activities.
If your company wants to get ahead of the competition and pursue a permanent Site License, Dell Tech can help you navigate the NHP Site Licensing requirements and help you put together a full package that meets the regulations. We can submit the application on your behalf or just review your Standard Operating Procedures (SOP’s) and records to ensure they will meet the Good Manufacturing Practice (GMP) requirements. Call us today.
Dell Tech Laboratories
Senior Regulatory Affairs Specialist
519-858-5021 x 2028
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.