COVID NHP Site License expiration: Less than16 weeks away!
By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
If you are one of over 1900 companies given a COVID Temporary Site License to manufacturer, package, label, or import Alcohol-based Hand Sanitizers (Natural Health Products) earlier this year, that license is set to expire in March 2021.
That is less than 16 weeks away! With vaccine trials well underway and showing excellent outcomes so far, this March 21 deadline will likely not be extended. If you plan to apply for a Permanent Site License, our recommendation is that you consider submitting your dossier now, before the other 1900 companies jump into the same queue! Your application will be an entirely NEW submission. While the process to apply is similar to what you provided for your temporary COVID license, the documentation required will be more involved. Your approval from NNHPD will take 35 – 65 days. You will need to provide more detailed information on your entire quality management system and that of your foreign manufacturers. This will include details about premises, operations, quality inspection protocols, recall, and adverse event protocols, and stability data to support your shelf life and expiry date.
Dell Tech can help you navigate the Site Licensing documentation and provide you recommendations to help move your Site License application through NNHPD quickly and easily. We look forward to being of service.
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