Getting your site license application approved for natural health products just got a little bit easier in Canada. After much anticipation the Natural and Non-Prescription Health Products Directorate (NNHPD) published their new Site License Guidance Document, Version 3.0 in December of 2015.
Highlights of the new document include:
- Explanation of the different types of deficiencies that may be noted during review of your site license application so you can understand what NOT to do.
- Target review times for NNHPD approval of your site license application, and site license amendments such as addition of new foreign sites to your license.
- Confirmation that an NSF Certificate (International Standard 173, Section 8 for Dietary Supplements) is acceptable as GMP evidence for participating facilities outside of Canada.
- Details on how foreign sites can make use of Health Canada’s Foreign Site Reference Number process to get their facilities involved in exporting natural health products to Canada.
One of the most exciting changes has been the site license review group’s acceptance of Health Canada’s secure on-line submission system (ePost Connect™) for site license applications and site license amendments. This will allow for faster Health Canada approvals, and it eliminates the need for printers, papers, couriers, and CDs.
For facilities involved in the supply chain process of manufacturing and importation of natural health products into Canada, these are some definite improvements that will reduce the regulatory burden and time to approval of your site license applications.